Needle-knife lumbosacral therapy for Lumbar Disc herniation: A Single-Center, Multi-Sample, Single-Blind Randomized Controlled Trial

Needle-knife lumbosacral therapy for Lumbar Disc herniation: A Single-Center, Multi-Sample, Single-Blind Randomized Controlled Trial | Research Square window.SnipcartSettings = { analytics: { enabled: false } }; (function() { var accessVector = localStorage.getItem('access_vector') || ''; window.dataLayer = window.dataLayer || []; if (accessVector) { window.dataLayer.push({ user: { profile: { profileInfo: { snid: accessVector } } } }); } })(); (function(w,d,s,l,i){w[l]=w[l]||[];w[l].push({'gtm.start':new Date().getTime(),event:'gtm.js'});var f=d.getElementsByTagName(s)[0],j=d.createElement(s),dl=l!='dataLayer'?'&l='+l:'';j.async=true;j.src='https://www.googletagmanager.com/gtm.js?id='+i+dl;f.parentNode.insertBefore(j,f);})(window,document,'script','dataLayer','GTM-K279D39R'); Browse Preprints In Review Journals COVID-19 Preprints AJE Video Bytes Research Tools Research Promotion AJE Professional Editing AJE Rubriq About Preprint Platform In Review Editorial Policies Our Team Advisory Board Help Center Sign In Submit a Preprint Cite Share Download PDF Research Article Needle-knife lumbosacral therapy for Lumbar Disc herniation: A Single-Center, Multi-Sample, Single-Blind Randomized Controlled Trial Yiming Zhang, Ruiguo Li, Xiaohong Zhang, Zhanyou Wang, Ziwei Zhang, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-9323687/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 4 You are reading this latest preprint version Abstract Background Lumbar disc herniation (LDH) is a common spinal disorder causing significant pain and dysfunction. Traditional acupuncture is a widely used non-pharmacological treatment for LDH. Recently, needle-knife therapy has emerged as a potential alternative. Objective Exploring the clinical efficacy of needle-knife lumbosacral therapy for LDH and comparing its advantages with conventional acupuncture therapy. Methods A total of 74 patients with LDH were enrolled and randomly assigned to either the experimental group (n = 37), receiving needle-knife lumbosacral therapy, or the control group (n = 37), treated with conventional acupuncture, with the same treatment location in both groups. Recruitment occurred between February 15, 2025, and June 15, 2025, with the final follow-up conducted on October 18, 2025. Both groups underwent a two-week therapeutic intervention. Outcome measures included treatment efficacy rate, Visual Analog Scale (VAS) scores, Oswestry Disability Index (ODI), and lumbar functional mobility (LFM), assessed at baseline, post-treatment, and three-month follow-up. Additionally, serum levels of inflammatory cytokines were measured. Adverse events were monitored throughout the treatment period. Results The total effective rate in the experimental group was significantly higher than that in the control group ( P < 0.05). Both groups demonstrated reductions in VAS and ODI scores post-treatment, with the experimental group displaying lower values [VAS score: -1.16 (0.16); P < 0.05; ODI score: -3.78 (0.37); P < 0.05]. Serum concentrations of inflammatory biomarkers were attenuated in both groups, with more reductions observed in the experimental group [TNF-α: -0.18 (-0.22); P < 0.05; IL-1β: -0.13 (-0.05); P < 0.05; IL-6: -0.47 (-0.28); P < 0.05]. LFM scores improved in both groups, with greater improvement in the experimental group [lumbar flexion: 2.81 (-0.12); P < 0.05; left lateral flexion: 0.70 (0.24); P < 0.05; right lateral flexion: 0.41 (0.06); P < 0.05]. At the 3-month follow-up, both groups showed further improvements in VAS, ODI, and LFM scores, with greater improvements in the experimental group ( P < 0.05). No serious adverse events were reported. Conclusion Two weeks of needle-knife lumbosacral therapy for LDH has a good therapeutic effect in relieving patients' lumbar pain and improving their lumbar mobility disorders. Moreover, the therapeutic effect is superior to that of traditional acupuncture treatment. Lumbosacral Co-Treatment Needle-Knife Lumbar Disc Herniation Clinical Observation Controlled Trial Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 Introduction Lumbar disc herniation (LDH) is a prevalent clinical condition, with global epidemiological studies reporting an annual incidence of approximately 2–3% and a lifetime risk of 5–10%. It exhibits a male-to-female ratio of about 7:1 and most commonly affects individuals aged 30–50 years [ 1 ] . Based on the extent of nucleus pulposus protrusion, LDH is categorized into bulging, protrusion, and extrusion types (Fig. 1 ) [ 2 ] . The fundamental pathogenesis of LDH involves intervertebral disc degeneration and mechanical stress [ 3 ] . With advancing age, the nucleus pulposus loses proteoglycans and water, diminishing its elasticity. Concurrently, the annulus fibrosus also undergoes changes, including collagen breakdown and fissure formation [ 4 ] . Under prolonged axial loading, rotational forces, or flexion stress, the degenerated nucleus pulposus herniates through weakened areas of the annulus fibrosus (often posterolaterally), compressing nerve roots or the dural sac [ 5 ] . This mechanical compression is accompanied by the release of inflammatory mediators such as IL-6, TNF-α, and PGE₂, leading to nerve root ischemia, edema, and pain sensitization [ 6 ] . Clinical manifestations include low back pain accompanied by radiating lower limb pain, exacerbated by coughing, prolonged sitting, or flexion movements, significantly impairing patients' daily work and life. Current treatment of LDH primarily relies on conservative treatments, including traditional acupuncture, manual therapy, and oral medications [ 7 ] . While these modalities demonstrate certain efficacy, they have some limitations, such as extended treatment duration, failure to alleviate mechanical compression of nerve roots, and a high recurrence rate following discontinuation of therapy [ 8 ] . Given these constraints, the desire to explore alternative approaches with high feasibility and few adverse effects is growing in Western societies. Needle-knife therapy evolved from traditional acupuncture therapy, compensating for the limitation of conventional acupuncture in effectively releasing the tension of soft tissue surrounding the spine [ 9 ] . A recent clinical study demonstrated that needle-knife therapy significantly reduces VAS and ODI scores in LDH patients, suggesting superior efficacy compared to traditional acupuncture [ 10 ] . The sacroiliac joint serves as a foundational component in the spine–pelvis–lower limb mechanical chain [ 11 ] . During the acute phase of LDH, approximately 68–85% of patients develop sacroiliac joint dysfunction, resulting in the persistence and chronicity of low back pain symptoms [ 12 ] . Thus, treatment of the sacroiliac joint should be prioritized in LDH therapy. Based on these considerations, we conducted a single-blind randomized controlled trial to evaluate the effect of needle-knife lumbosacral therapy in patients with LDH and to compare its therapeutic advantages over conventional acupuncture. Method Study Design This study was a single-blind clinical trial. Considering the particularity of the treatment methods in needle-knife therapy and acupuncture, therapists and patients were aware of the group assignments and specific treatment methods. Therefore, blinding was implemented only for the outcome assessors. Participants with LDH were randomly allocated at a 1:1 ratio into either an experimental group or a control group using a random number table method. Both groups received standard treatment (ST). The experimental group received needle-knife lumbosacral therapy (NKT), while the control group received acupuncture therapy (AT). The trial protocol was approved by XXX (Approval No: 2025HL-003) and monitored by a safety oversight committee. The study protocol and statistical analysis plan are available in Supplement 1. All participants provided written informed consent under the principles of the Declaration of Helsinki [ 13 ] . The trial was designed and reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT [ 14 ] ) guidelines and the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA [ 15 ] ). The study was registered with the International Traditional Medicine Clinical Trial Registration Platform (Registration ID:XXX), and the protocol has been made publicly accessible. Participants Patients from the Acupuncture Department of the Third Affiliated Hospital of Henan University of Chinese Medicine were screened according to the following inclusion and exclusion criteria. Inclusion Criteria: 1. Patients who met the diagnostic criteria for LDH in the "Diagnostic Criteria for Traditional Chinese Medicine Diseases" in China (low back pain accompanied by radiating leg pain). 2. Aged between 20 and 65 years old. 3. With symptoms lasting for 3 months or longer. 4. Visual Analog Scale (VAS) score > 5 points. Exclusion Criteria: 1. Patients with vertebral fractures, spinal infections, or active inflammatory diseases within the past year. 2. Patients who were unable to complete the assessment. 3. Patients suffering from serious diseases (such as cancer, severe cardiovascular diseases like heart failure, advanced liver diseases including liver cirrhosis and liver failure, severe blood diseases like leukemia, and other life-threatening diseases). 4. Pregnant women, women planning to conceive, or lactating women. 5. Patients who had participated in other acupuncture therapies within the past month. Withdrawal Criteria: 1. Patients who did not follow the treatment protocol or received additional treatments not specified in the study during the treatment period. 2. Patients who experienced serious adverse reactions during the treatment process. 3. Patients who were unable to cooperate with the treatment for other reasons and voluntarily withdrew from the study. Randomization and blinding Randomization was performed by a statistician not involved in the study using SPSS Statistics Version 26.0 (IBM). Random numbers were generated using the SPSS 26.0 software to create randomization cards, which were then placed in sealed opaque envelopes. The attending physician randomly distributed these envelopes to participants, who were assigned to the experimental group or the control group in a 1:1 ratio—based on the randomization card information within the envelope. All efficacy assessments were conducted by a clinician unaware of the study design or patient allocation. Intervention All participants in both the experimental and control groups received ST (comprised of controlled management of hypertension and hyperglycemia, supplemented with oral methylcobalamin, 500 µg three times daily). Both groups underwent a systematic treatment course lasting two weeks. Acupuncture procedures were performed by a licensed practitioner with over five years of clinical experience, while needle-knife therapy was conducted by a chief physician. Prior to the study, all therapists received standardized training focusing on precise localization of acupoints and needle-knife release techniques. The control group received acupuncture treatment four times per week (Monday-Thursday), with each session lasting 40 minutes. A complete treatment course consists of two weeks. The acupoint prescription was determined based on theories of Traditional Chinese Medicine and previous literature related to acupuncture for LDH [ 16 ] . Treatment sites were selected at the transverse processes of L3, L4, and L5 bilaterally, corresponding to the acupoints Shen shu (BL23), Da chang shu (BL25), and Qi hai shu (BL21), as well as bilaterally at the sacral foramina Ci liao (BL32) and Zhong liao (BL33). Acupoint nomenclature and localization followed the National Standard of the People’s Republic of China (GB/T 12346 − 2006). Detailed information regarding the locations of these acupoints can be found in Supplement2, e Fig. 1 . All treatments were performed with participants in a prone position. Sterile, single-use stainless steel acupuncture needles (manufactured by Bangde Medical Equipment Co., Maanshan, China; specifications: 0.30 × 25 mm, 0.30 × 40 mm, and 0.30 × 75 mm) were used. Needle gauge selection and acupuncture depth reference Supplement 2, eTable 1. For each acupoint, employ needling techniques such as lifting and thrusting, twisting, and rotating for one minute to induce the sensation of deqi, characterized by local soreness, numbness, distension, and pain. After achieving deqi, retain the needles for 30 minutes. Participants in the experimental group received needle-knife treatment four times per week (Monday-Thursday). Each treatment session targeted two specific acupoints. The entire intervention lasted two weeks as one treatment course. 1. Localization: The treatment location in the experimental group was the same as that in the control group. 2. Patient's position: Patients were placed in a prone position with the face resting in the face hole of the treatment table to ensure neck relaxation. The upper limbs were positioned alongside the body or allowed to hang freely from both sides of the table. 3. Disinfection: The skin around the treatment site was disinfected using iodophor-saturated cotton swabs, wiping in three concentric circles outward from the treatment point, ensuring no gaps are left. The disinfection area extended radially at least 10 cm from the site. A sterile aperture drape was then applied to expose the target area while maintaining an aseptic field. 4. Anesthesia: Local anesthesia was administered using a 0.5% lidocaine solution. A volume of 1 mL was injected per treatment site. During the procedure, patients were instructed to breathe normally. The needle was advanced slowly until bony contact was achieved. A retrograde injection technique was employed, distributing the 1 mL solution gradually from deep to superficial tissue. 5. The needle-knife therapy was performed using a Zhougong-brand Type I No. 3 needle-knife (1.0 mm × 80 mm) The shape and specification of the needle-knife are shown in Fig. 2 . The “three-step slow stratified needle insertion technique” [ 17 ] was employed to advance the needle-knife gradually to the bony surface. During needle-knife insertion, longitudinal cutting and transverse stripping were performed at the superficial, intermediate, and deep soft tissue. Emphasis was placed on soft tissue adhesions around the spinal vertebrae. A detailed description of the operational method is provided in Supplement 2, eTable 2. Primary outcome measure 1. Treatment efficacy rate; 2. The VAS score was used to evaluate the pain intensity. This scale, ranging from 0 to 10, defines 0 as "no pain" and 10 as "the worst pain imaginable." During assessment, patients were presented with the unmarked side of the scale and asked to slide the cursor to a position corresponding to their perceived pain level. The physician then recorded the score based on the cursor’s position. 3. The ODI score was employed to evaluate functional impairment associated with LDH. Scores were classified as follows: 0%–20% Mild dysfunction: daily activities largely maintained; 21%–40% Moderate disability: some activities require assistance; 41%–60% Severe disability: daily life significantly affected, often requiring medical intervention; 61%–80% Crippling disability: most activities cannot be performed; 81%–100% Complete disability: bedbound or fully dependent on others. The detailed ODI assessment form is presented in Supplement 2, e Fig. 2 . VAS and ODI scores were evaluated at baseline, post-treatment, and at the 3-month follow-up. Secondary outcome measures 1. Lumbar Functional Mobility (LFM): A digital protractor was used to measure changes in lumbar flexion and bilateral lateral flexion in both groups before treatment, after one course of treatment, and at a 3-month follow-up to evaluate clinical efficacy. 2. Serum levels of TNF-α, IL-1β, and IL-6 were measured in both groups before treatment and after one course of treatment. Quantification was performed using enzyme-linked immunosorbent assay (ELISA). Detailed methodological procedures are described in Supplement 2, e Table 3. All treatment-related adverse events (AEs), including needle fainting, needle breakage, hematoma, and infection, were monitored and recorded. The severity of each AE (mild, moderate, or severe) was assessed by the investigators to determine whether treatment could be continued. This study reports the number and severity of all observed AEs. Efficacy Evaluation Criteria The therapeutic effects were classified into four grades according to the subsequent criteria: 1. Cured: Complete resolution of lumbago and leg pain, straight leg raise (SLR) test ≥ 70°, and no restrictions in activities of daily living. 2. Markedly Effective: Significant pain reduction, substantial functional improvement, SLR test ≥ 60°, and the capacity to return to daily activities and work. 3. Effective: Moderate pain relief, partial functional recovery, and an increase in SLR. 4. Ineffective: Absence of improvement or exacerbation of symptoms, with persistent functional impairment. Sample Size The sample size for this study was carefully calculated based on prior clinical research regarding needle-knife therapy for LDH [ 18 ] and our clinical experience. The mean VAS score after treatment in the experiment group was 3.11, while that in the control group was 5.06. The standard deviation observed in the experiment group was 1.23, whereas the control group exhibited a standard deviation of 2.10. The study design incorporated two groups, each adhering to a 1:1 allocation ratio to ensure equitable representation. Employing the sample size formula n = 2(Zα/2 + Zβ)² × δ²/(µt + µc-Δ)², with reference values α = 0.05 and β = 0.20, the calculated sample size was 35. A total of 70 patients were required across both groups. Accounting for potential attrition, a total of 74 patients were enrolled. Statistical Analysis Data processing and analysis were performed using IBM SPSS Statistics 26 software. Normally distributed continuous variables are presented as mean ± standard deviation (x ± s). Independent samples t-tests were used for between-group comparisons, and paired samples t-tests were used for within-group comparisons at different time points. Non-normally distributed quantitative data are expressed as median [M(P25,P75)]. The Wilcoxon signed-rank test or Friedman test was used for intergroup and intragroup comparisons. Categorical data were analyzed using the chi-square test. P < 0.05 indicated statistically significant differences. Results Patients and characteristics Between February 15, 2025, and June 15, 2025, a total of 74 eligible patients were enrolled, including 32 females and 42 males. Among them, 70 patients (95%) completed the intervention and the 3-month follow-up, consisting of 30 females (42.8%) and 40 males (57.2%), with a mean (SD) age of 44.26 (8.35) years. The participant flow diagram is presented in Figure 3. Baseline demographic and clinical characteristics of the included patients are summarized in Table 1. Primary outcome Table 2 provides a comparative analysis of the primary outcomes within both groups pre- and post-treatment, along with follow-up changes in VAS and ODI scores for both groups. A total of 70 patients completed all assessments. Following one treatment cycle, the experiment group exhibited a mean (SD) VAS score of 2.25 (1.38), representing a 4.5 (0.15) reduction from baseline. The control group demonstrated a mean (SD) post-treatment VAS score of 3.41 (1.22), with a reduction of 2.91 (0.58) from baseline. The disparity is statistically significant ( P <0.05). The experiment group's mean (SD) ODI score was 16.35 (2.55), a decrease of 24.3 (0.66) from baseline, whereas the control group's score was 20.13 (2.18), a decrease of 21.38 (0.25) from baseline. The disparity is statistically significant ( P <0.05). The experiment group showed a greater reduction in VAS score by 1.16 points and in ODI score by 3.78 points compared to the control group post-treatment ( P <0.05). The overall effective rate in the experiment group was 90%, and in the control group, it was 87%. At the 3-month follow-up, both groups showed further improvement in VAS and ODI scores compared to post-treatment scores, with the experiment group demonstrating greater improvement ( P <0.05). The specific score changes before and after treatment are shown in Figure 4. Secondary outcome Regarding LFM, the experiment group demonstrated higher scores compared to the control group across all components, with notable differences in lumbar flexion 2.81 (-0.12), left lateral flexion 0.70 (0.24), and right lateral flexion 0.41 (0.06). The disparity is statistically significant ( P <0.05). In terms of inflammatory markers, including TNF-α, IL-1β, and IL-6, the experiment group exhibited greater reductions than the control group: TNF-α: -0.18 (-0.22); IL-1β: -0.13 (-0.05); IL-6: -0.47 (-0.28). At the 3-month follow-up, both groups showed further improvements in lumbar flexion and bilateral lateral flexion compared to post-treatment measurements. The degree of improvement was greater in the experiment group than in the control group ( P < 0.05). The specific score changes before and after treatment are shown in Figure 4. Adverse event In the experimental group, one patient developed a subcutaneous hematoma after treatment, which resolved following brief local massage. In the control group, two patients experienced mild needle syncope (fainting during acupuncture) during the first acupuncture session, presenting with dizziness, nausea, and vomiting. These patients were immediately placed in a supine position with their legs elevated to promote venous return and were given warm sugar water to drink. Their symptoms resolved completely after 5 minutes of rest. Discussion This single-center randomized controlled trial demonstrated that a 14-day needle-knife lumbosacral therapy significantly reduced patients' VAS and ODI scores while also improving LFM. Compared to the control group (AT), the clinical efficacy was notably better ( P <0.05). A three-month follow-up revealed that improvements in VAS, ODI, and LFM persisted at the end of the follow-up period, indicating that needle knife lumbosacral therapy has long-term effects. Additionally, no severe reactions were reported during the trial, suggesting that needle knife lumbosacral therapy is a safe and effective treatment. In this study, the within-group changes with a large effect size in pain intensity exceeded the minimal clinically important difference (> 10%) for VAS, indicating clinically meaningful improvements [19] . These results suggest that needle knife lumbosacral therapy effectively reduces localized pain in LDH patients, with sustained therapeutic effect throughout the 3-month period. The similar findings have been found in the previous studies regarding the positive role of the needle-knife therapy. A single-blind randomized controlled trial has demonstrated that needle-knife therapy provides more significant short- and long-term pain reduction and recovery of local dysfunction compared with acupuncture therapy [20] .Currently, needle-knife therapy for LDH primarily focuses on the release of tension in soft tissue surrounding the spinal column. For example, Lin et al. have indicated that release targeting the transverse processes of L 3 , L 4 , and L 5 is a key aspect of this therapy [21] Meanwhile, Liu et al. have emphasized the importance of releasing the ligamentum flavum during needle-knife therapy [22] . Building on previous research, this study further emphasized treatment of the sacroiliac joint. The results revealed that needle-knife lumbosacral therapy achieved more significant improvements in both pain relief and functional recovery compared to previous studies. The results of this study are as follows: Regarding VAS scores, prior research indicated an intra-group reduction from 6.17 to 2.48 [23] . In the present study, the NKT group demonstrated a 4.5-point reduction in VAS scores within the group. For ODI scores, previous studies reported a 15-point reduction from baseline. Our findings indicate that the intergroup difference in the NKT group post-treatment was 4 points, with a reduction of 24.3 points from baseline. These results not only confirmed the therapeutic efficacy of needle-knife intervention in managing LDH but also demonstrated the clinical advantage of needle-knife lumbosacral therapy over conventional needle-knife therapy. The therapeutic mechanisms underlying needle-knife intervention in LDH operate through four interconnected pathways. Structurally, precise percutaneous release of paravertebral soft tissue constraints alleviates mechanical nerve root compression by disrupting adhesive scar tissue and myofascial contractures [24] . At the cellular level, mechanical stimulation of nociceptive fibers triggers TRPV1 channel opening, initiating intracellular calcium influx that subsequently dampens NF-κB nuclear translocation and downstream pro-inflammatory gene transcription—manifesting as reduced circulating IL-6 and TNF-α alongside elevated IL-10 [25] . Biomechanically, capsular release of zygapophyseal joints and intertransverse ligament mobilization corrects segmental rotational dysfunction (3°–5°) and pelvic obliquity (2°–3°), reestablishing lumbopelvic-lower extremity kinetic chain alignment [26] . Neurochemically, paraspinal afferent stimulation engages spinal cord μ-opioid receptor populations and precipitates β-endorphin secretion (2–3-fold elevation), generating prolonged antinociception that reaches maximal intensity at 24 hours post-procedure and persists 50% beyond conventional acupuncture duration [27] . LDH is closely related to chronic soft tissue injuries [28] . In the early stage of LDH, it mostly presents as multifidus muscle atrophy and adhesion of the thoracolumbar fascia, resulting in instability of the lumbar segments, microcracks in the annulus fibrosus, and gradually accumulating micro-damage [29] . Subsequently, the sacrospinous ligament and the gluteus maximus undergo compensatory hypertrophy to maintain the stability of the lumbar segments, and the additional tension is continuously transmitted through the fascial chain to the intervertebral disc [30] . Once the compensatory muscle groups become fatigued or form scar contractures, the accumulated stress in the intervertebral disc will exceed the degeneration threshold, thereby causing the nucleus pulposus to protrude [31] .Therefore, during the treatment, needle-knife therapy emphasizes the release of tension in soft tissues surrounding the spine to restore the dynamic biomechanical balance of the spine [32] . Based on extensive clinical experience, our team has proposed the “Iceberg Theory” [33] of chronic soft tissue injury (Figure 5). We believe that most chronic soft tissue injuries evolve gradually. As the patient's physiology adapts to the localized pathological changes, the clinical presentation becomes less prominent. Consequently, chronic soft tissue injury can be divided into visible and hidden parts. The “tip of the iceberg” signifies the most symptomatic region—the area eliciting the greatest discomfort or functional impairment—and is readily apparent to clinicians. Submerged “beneath the waterline are subclinical soft tissue injuries, which may be vaguely perceived or entirely unnoticed by the patient and often missed by physicians. These concealed injuries represent the continuous progression of the disease. For diseases related to soft tissue injuries, the covert component is the primary target of clinical intervention. Just as “the center of gravity of an iceberg lies below the water level rather than above it,” the core pathogenesis often lies beyond the patient's overt symptoms. This necessitates a focus beyond superficial manifestations to address the root cause of the disease, identifying the true source of the patient's pain. The “needle-knife lumbosacral therapy” is established based on this rationale. The sacral dorsal root ganglion (DRG) is a key sensitization center for chronic low back pain and lower extremity radicular pain [34] . Chronic inflammatory or mechanical stimulation of the surrounding soft tissues, including the multifidus muscle, sacrospinalis muscle, and sacroiliac ligament, can result in sustained DRG activation, contributing to the chronicity and refractoriness of low back pain symptoms [35] . Consequently, soft tissue release in the sacral region can reduce mechanical sensitization of the DRG, thereby mitigating low back pain symptoms. This study has several strengths. the use of blinding in the trial design and execution, which improved the reliability and validity of the results. Standardized training for practitioners before the intervention, along with standardization for manipulation techniques and needling depth, minimized operator-dependent variability and enhanced the evidence's quality. Moreover, a comprehensive battery of outcome measures, such as pain scores, dysfunction assessments, range of motion, and inflammatory markers, enabled a thorough evaluation of the needle-knife's clinical efficacy in treating LDH. However, several limitations should be acknowledged. The unique characteristics of needle-knife and acupuncture therapies precluded the blinding of participants and practitioners, potentially introducing performance bias. Furthermore, the three-month follow-up period restricted the assessment of long-term effects and the durability of the intervention. Finally, the relatively small sample size and single-center recruitment may limit the generalizability of the results. Future research should consider conducting multi-sample and multi-center clinical studies to ensure the applicability of the results to a wider range of patients with LDH. Conclusion The study's results indicate that lumbosacral needle-knife therapy is effective in reducing low back pain and improving local dysfunction in individuals with LDH. These findings support its potential for wider clinical implementation. Abbreviations LDH Lumbar disc herniation VAS Visual analog scale ODI Oswestry Disability Index NKT Needle knife therapy AT = acupuncture therapy LFM Lumbar Functional Mobility Declarations Acknowledgements Not applicable Ethics approval This retrospective study was conducted as part of the [XXX] project, which was approved by the Institutional Review Board of [XXX] (Approval No. [2025-HL003]). We have also registered with the International Traditional Medicine Clinical Trial Registration Platform (https://itmctr.ccebtcm.org.cn/mgt/dashboard ). Consent to participate All participants provided written informed consent under the principles of the Declaration of Helsinki. Funding This work was supported by the project of the Henan Province Chinese medicine research project (2024ZY2095). Conflict of interest The author declares no competing interests in this work. Author Contribution Yiming Zhang and Ruiguo Li participated in the design of this study . Xiaohong Zhang and Zhanyou Wang drafted the manuscript. Ziwei Zhang, Huanhuan Xu and Xiaofan Li critically revised the manuscript for important intellectual content. All authors read and approved the final manuscript. References Hincapié CA, Kroismayr D, Hofstetter L et al (2025) Incidence of and risk factors for lumbar disc herniation with radiculopathy in adults: a systematic review. 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Int J Mol Sci 25(7):3591. https://doi.org/10.3390/ijms25073591 Tables Table 1. Baseline Demographic and Clinical Characteristics of the Included Participants Characteristic Total sample (n = 74) NKT (n = 37) AT(n = 37) Pvalue Female 32 (43.2) 14 (37.8) 18 (45.71) >0.05 Male 42 (56.8) 23(62.2) 19 (54.29) 0.05 Yes 29 (39.2) 12 (32.4) 17 (45.9) >0.05 Age, mean (SD) 44.26 (8.35) 43.76 (9.23) 44.76 (7.39) >0.05 BMI, mean (SD) 22.23 (14.06) 22.40 (12.41) 22.05 (15.59) >0.05 Duration of illness (SD) 3.34 (3.05) 3.98 (3.5) 2.70 (2.5) >0.05 VAS, mean (SD) 6.53 (1.67) 6.75 (1.53) 6.32 (1.80) >0.05 ODI, mean (SD) 41.08 (2.87) 40.65 (3.21) 41.51 (2.43) <0.05 LFM (lumbar flexion) , mean (SD) 46.84 (7.28) 45.42 (8.63) 48.27 (5.30) <0.05 LFM (Left lateral flexion), mean (SD) 22.56 (3.31) 21.27 (3.53) 23.85 (3.10) 0.05 Blood serum levels of, TNF - α/ng ·L - 1 8.87 (1.51) 8.54 (1.35) 9.21 (1.60) <0.05 Blood serum levels of, IL - 6/ng ·L - 1 14.51 (2.19) 14.51 (2.23) 13.50 (2.09) <0.05 Blood serum levels of, IL - 1β/ng ·L - 1 6.51 (0.42) 6.60 (0.50) 6.43 (0.31) <0.05 Abbreviations: NKT: Needle knife therapy, AT: Acupuncture therapy， VAS: Visual Analogue Scale, ODI：Oswestry Disability Index, LFM: Lumbar Functional Mobility, BMI:Body Mass Index Table 2 Treatment Effects of NKT and AT group one course of treatment and 3 months of Follow-Up Outcome assessment NKT group(n=35) AT group(n=35) Score after treatment mean (SD) Pvalue Intra-group Score after treatment mean (SD) Pvalue Inter-group VAS Post treatment 2.25(1.38) <0.05 3.41(1.22) <0.05 Follow-up 1.93(0.55) <0.05 2.36(0.48) <0.05 ODI Posttreatment 16.35(2.55) <0.05 20.13(2.18) <0.05 Follow-up 13.17(1.72) <0.05 15.06(1.29) <0.05 Effective rate Posttreatment 90% 87% <0.05 LFM (lumbar flexion) Posttreatment 75.39(5.36) <0.05 72.58(5.48) <0.05 Follow-up 79.16(2.57) <0.05 76.21(2.13) <0.05 LFM (Left lateral flexion) Posttreatment 26.35(3.18) <0.05 25.65(1.62-2.45) <0.05 Follow-up 27.67(3.38) <0.05 26.93(2.79) <0.05 LFM (right lateral flexion) Posttreatment 26.74(2.95) <0.05 26.33(2.71) <0.05 Follow-up 28.05(2.34) <0.05 27.65(2.28) <0.05 Blood serum levels of, TNF - α/ng ·L – 1 Posttreatment 3.75(0.60) <0.05 3.93(0.82) <0.05 Blood serum levels of, IL - 6/ng ·L – 1 Posttreatment 3.35(0.47) <0.05 3.82(0.75) <0.05 Blood serum levels of, IL - 1β/ng ·L – 1 Posttreatment 3.52(0.48) <0.05 3.65(0.53) <0.05 Table 3 CONSORT 2025 checklist item description Section/topic No CONSORT 2025 checklist item description Reported on page no. Title and abstract Title and structured abstract 1a Identification as a randomised trial page4 line 88 1b Structured summary of the trial design, methods, results, and conclusions page2 Open science Trial registration 2 Name of trial registry, identifying number (with URL) and date of registration page4 line 102 Protocol and statistical analysis plan 3 Where the trial protocol and statistical analysis plan can be accessed page5 line 123 Data sharing 4 Where and how the individual de-identified participant data (including data dictionary), statistical code and any other materials can be accessed page 5 Funding and conflicts of interest 5a Sources of funding and other support (eg, supply of drugs), and role of funders in the design, conduct, analysis and reporting of the trial page14 line379 5b Financial and other conflicts of interest of the manuscript authors page 13 Introduction Background and rationale 6 Scientific background and rationale page4 Objectives 7 Specific objectives related to benefits and harms page13 Methods Patient and public involvement 8 Details of patient or public involvement in the design, conduct and reporting of the trial page9 line231 Trial design 9 Description of trial design including type of trial (eg, parallel group, crossover), allocation ratio, and framework (eg, superiority, equivalence, non-inferiority, exploratory) page 4-6 Changes to trial protocol 10 Important changes to the trial after it commenced including any outcomes or analyses that were not prespecified, with reason page9 Trial setting 11 Settings (eg, community, hospital) and locations (eg, countries, sites) where the trial was conducted page4 line106 Eligibility criteria 12a Eligibility criteria for participants page4 12b If applicable, eligibility criteria for sites and for individuals delivering the interventions (eg, surgeons, physiotherapists) page6 line137 Intervention and comparator 13 Intervention and comparator with sufficient details to allow replication. If relevant, where additional materials describing the intervention and comparator (eg, intervention manual) can be accessed page6-7 Outcomes 14 Prespecified primary and secondary outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome page5-7 Harms 15 How harms were defined and assessed (eg, systematically, non-systematically) page5 line123 Sample size 16a How sample size was determined, including all assumptions supporting the sample size calculation page8 line212 16b Explanation of any interim analyses and stopping guidelines page8 line199 Randomisation: Sequence generation 17a Who generated the random allocation sequence and the method used page5 line123 17b Type of randomisation and details of any restriction (eg, stratification, blocking and block size) page5 Reported on page no. Allocation concealment mechanism 18 Mechanism used to implement the random allocation sequence (eg, central computer/telephone; sequentially numbered, opaque, sealed containers), describing any steps to conceal the sequence until interventions were assigned page5 Implementation 19 Whether the personnel who enrolled and those who assigned participants to the interventions had access to the random allocation sequence page5 Blinding 20a Who was blinded after assignment to interventions (eg, participants, care providers, outcome assessors, data analysts) page4 line105 20b If blinded, how blinding was achieved and description of the similarity of interventions page5 Statistical methods 21a Statistical methods used to compare groups for primary and secondary outcomes, including harms page6 21b Definition of who is included in each analysis (eg, all randomised participants), and in which group page5 21c How missing data were handled in the analysis page7 21d Methods for any additional analyses (eg, subgroup and sensitivity analyses), distinguishing prespecified from post hoc page8-9 Results Participant flow, including flow diagram 22a For each group, the numbers of participants who were randomly assigned, received intended intervention, and were analysed for the primary outcome page9-10 22b For each group, losses and exclusions after randomisation, together with reasons page9-10 Recruitment 23a Dates defining the periods of recruitment and follow-up for outcomes of benefits and harms page9-10 23b If relevant, why the trial ended or was stopped page9 line264 Intervention and comparator delivery 24a Intervention and comparator as they were actually administered (eg, where appropriate, who delivered the intervention/comparator, how participants adhered, whether they were delivered as intended (fidelity)) page6 24b Concomitant care received during the trial for each group page7 Baseline data 25 A table showing baseline demographic and clinical characteristics for each group page9 line238 Numbers analysed, outcomes and estimation 26 For each primary and secondary outcome, by group: ● the number of participants included in the analysis ● the number of participants with available data at the outcome time point ● result for each group, and the estimated effect size and its precision (such as 95% confidence interval) ● for binary outcomes, presentation of both absolute and relative effect size page10 Harms 27 All harms or unintended events in each group page10 Ancillary analyses 28 Any other analyses performed, including subgroup and sensitivity analyses, distinguishing pre-specified from post hoc page9 Discussion Interpretation 29 Interpretation consistent with results, balancing benefits and harms, and considering other relevant evidence page10-11 Limitations 30 Trial limitations, addressing sources of potential bias, imprecision, generalisability, and, if relevant, multiplicity of analyses page12 Citation: Hopewell S, Chan AW, Collins GS, Hróbjartsson A, Moher D, Schulz KF, et al. CONSORT 2025 Statement: updated guideline for reporting randomised trials. BMJ. 2025; 388:e081123. https://dx.doi.org/10.1136/bmj-2024-081123 © 2025 Hopewell et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. *We strongly recommend reading this statement in conjunction with the CONSORT 2025 Explanation and Elaboration and/or the CONSORT 2025 Expanded Checklist for important clarifications on all the items. We also recommend reading relevant CONSORT extensions. See www.consort-spirit.org. Additional Declarations No competing interests reported. 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Also discoverable on Platform About Our Team In Review Editorial Policies Advisory Board Help Center Resources Author Services Accessibility API Access RSS feed Manage Cookie Preferences © Research Square 2026 | ISSN 2693-5015 (online) Privacy Policy Terms of Service Do Not Sell My Personal Information {"props":{"pageProps":{"initialData":{"identity":"rs-9323687","acceptedTermsAndConditions":true,"allowDirectSubmit":false,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":622885127,"identity":"071f83e3-625b-493b-b743-5d0d74194ac0","order_by":0,"name":"Yiming Zhang","email":"","orcid":"","institution":"Henan University of Traditional Chinese Medicine","correspondingAuthor":false,"prefix":"","firstName":"Yiming","middleName":"","lastName":"Zhang","suffix":""},{"id":622885128,"identity":"e71ed528-7641-4f00-bb8d-3052917ac632","order_by":1,"name":"Ruiguo 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lumbar disc herniation\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage1.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-9323687/v1/f9ab84cd0fb0ae56ce7cf883.jpeg"},{"id":107490156,"identity":"72fc9e33-bfa1-43ab-b73d-2457baabdd3b","added_by":"auto","created_at":"2026-04-22 02:50:50","extension":"jpeg","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":359138,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eshape and specification of the needle knife\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage2.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-9323687/v1/15a5ea599390a01fdb4c4cc9.jpeg"},{"id":107490137,"identity":"fb7d43eb-0e7b-4e14-a31b-da82d32bc42f","added_by":"auto","created_at":"2026-04-22 02:50:34","extension":"jpeg","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":468925,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003ePatient inclusion process\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage3.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-9323687/v1/299b076c3ed825f469504249.jpeg"},{"id":107448779,"identity":"3aefc41c-542c-4ef9-9d0d-2ed3bfa8697e","added_by":"auto","created_at":"2026-04-21 14:59:26","extension":"jpeg","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":246823,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eGraph showing changes in primary and secondary outcomes\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"floatimage4.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-9323687/v1/977100e687b68ed43c44580e.jpeg"},{"id":107487757,"identity":"82fa0e63-79ec-420b-b3e3-67b6948aae2b","added_by":"auto","created_at":"2026-04-22 02:42:41","extension":"jpeg","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":89831,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eiceberg theory\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe \"tip of the iceberg\" signifies the most symptomatic region—the area eliciting the greatest discomfort or functional impairment—and is readily apparent to clinicians. Submerged \"beneath the waterline\" are subclinical soft tissue injuries, which may be vaguely perceived or entirely unnoticed by the patient and often missed by physicians\u003c/p\u003e","description":"","filename":"floatimage5.jpeg","url":"https://assets-eu.researchsquare.com/files/rs-9323687/v1/c4e115f080009018ce675a92.jpeg"},{"id":108181034,"identity":"17ebdd3d-849b-4eb4-a595-daf72317fe56","added_by":"auto","created_at":"2026-04-30 08:56:27","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2044334,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-9323687/v1/67e0a5e7-a968-490b-9f0a-45959e1262e5.pdf"},{"id":107868295,"identity":"801e9c5c-7ea7-4af5-8a11-dde192546fb1","added_by":"auto","created_at":"2026-04-27 07:09:51","extension":"docx","order_by":1,"title":"","display":"","copyAsset":false,"role":"supplement","size":1047038,"visible":true,"origin":"","legend":"","description":"","filename":"Supplement1.docx","url":"https://assets-eu.researchsquare.com/files/rs-9323687/v1/39118adaca36828c40917f4d.docx"},{"id":107448777,"identity":"fc9fbda5-e31e-48de-967d-9efa2accffc8","added_by":"auto","created_at":"2026-04-21 14:59:26","extension":"docx","order_by":2,"title":"","display":"","copyAsset":false,"role":"supplement","size":1230529,"visible":true,"origin":"","legend":"","description":"","filename":"Supplement2.docx","url":"https://assets-eu.researchsquare.com/files/rs-9323687/v1/bb19025fa0041e6e70e1083a.docx"}],"financialInterests":"No competing interests reported.","formattedTitle":"Needle-knife lumbosacral therapy for Lumbar Disc herniation: A Single-Center, Multi-Sample, Single-Blind Randomized Controlled Trial","fulltext":[{"header":"Introduction","content":"\u003cp\u003eLumbar disc herniation (LDH) is a prevalent clinical condition, with global epidemiological studies reporting an annual incidence of approximately 2\u0026ndash;3% and a lifetime risk of 5\u0026ndash;10%. It exhibits a male-to-female ratio of about 7:1 and most commonly affects individuals aged 30\u0026ndash;50 years \u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]\u003c/sup\u003e. Based on the extent of nucleus pulposus protrusion, LDH is categorized into bulging, protrusion, and extrusion types (Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e)\u003csup\u003e[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/sup\u003e. The fundamental pathogenesis of LDH involves intervertebral disc degeneration and mechanical stress\u003csup\u003e[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e. With advancing age, the nucleus pulposus loses proteoglycans and water, diminishing its elasticity. Concurrently, the annulus fibrosus also undergoes changes, including collagen breakdown and fissure formation\u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e. Under prolonged axial loading, rotational forces, or flexion stress, the degenerated nucleus pulposus herniates through weakened areas of the annulus fibrosus (often posterolaterally), compressing nerve roots or the dural sac\u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e. This mechanical compression is accompanied by the release of inflammatory mediators such as IL-6, TNF-α, and PGE₂, leading to nerve root ischemia, edema, and pain sensitization\u003csup\u003e[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e. Clinical manifestations include low back pain accompanied by radiating lower limb pain, exacerbated by coughing, prolonged sitting, or flexion movements, significantly impairing patients' daily work and life.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003eCurrent treatment of LDH primarily relies on conservative treatments, including traditional acupuncture, manual therapy, and oral medications\u003csup\u003e[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/sup\u003e. While these modalities demonstrate certain efficacy, they have some limitations, such as extended treatment duration, failure to alleviate mechanical compression of nerve roots, and a high recurrence rate following discontinuation of therapy\u003csup\u003e[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/sup\u003e. Given these constraints, the desire to explore alternative approaches with high feasibility and few adverse effects is growing in Western societies.\u003c/p\u003e \u003cp\u003eNeedle-knife therapy evolved from traditional acupuncture therapy, compensating for the limitation of conventional acupuncture in effectively releasing the tension of soft tissue surrounding the spine\u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e. A recent clinical study demonstrated that needle-knife therapy significantly reduces VAS and ODI scores in LDH patients, suggesting superior efficacy compared to traditional acupuncture\u003csup\u003e[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/sup\u003e. The sacroiliac joint serves as a foundational component in the spine\u0026ndash;pelvis\u0026ndash;lower limb mechanical chain\u003csup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003e. During the acute phase of LDH, approximately 68\u0026ndash;85% of patients develop sacroiliac joint dysfunction, resulting in the persistence and chronicity of low back pain symptoms\u003csup\u003e[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]\u003c/sup\u003e. Thus, treatment of the sacroiliac joint should be prioritized in LDH therapy. Based on these considerations, we conducted a single-blind randomized controlled trial to evaluate the effect of needle-knife lumbosacral therapy in patients with LDH and to compare its therapeutic advantages over conventional acupuncture.\u003c/p\u003e"},{"header":"Method","content":"\u003cdiv id=\"Sec3\" class=\"Section2\"\u003e \u003ch2\u003eStudy Design\u003c/h2\u003e \u003cp\u003eThis study was a single-blind clinical trial. Considering the particularity of the treatment methods in needle-knife therapy and acupuncture, therapists and patients were aware of the group assignments and specific treatment methods. Therefore, blinding was implemented only for the outcome assessors. Participants with LDH were randomly allocated at a 1:1 ratio into either an experimental group or a control group using a random number table method. Both groups received standard treatment (ST). The experimental group received needle-knife lumbosacral therapy (NKT), while the control group received acupuncture therapy (AT). The trial protocol was approved by XXX (Approval No: 2025HL-003) and monitored by a safety oversight committee. The study protocol and statistical analysis plan are available in Supplement 1. All participants provided written informed consent under the principles of the Declaration of Helsinki\u003csup\u003e[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e. The trial was designed and reported in accordance with the Consolidated Standards of Reporting Trials (CONSORT\u003csup\u003e[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]\u003c/sup\u003e) guidelines and the Standards for Reporting Interventions in Clinical Trials of Acupuncture (STRICTA\u003csup\u003e[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/sup\u003e). The study was registered with the International Traditional Medicine Clinical Trial Registration Platform (Registration ID:XXX), and the protocol has been made publicly accessible.\u003c/p\u003e \u003c/div\u003e\n\u003ch3\u003eParticipants\u003c/h3\u003e\n\u003cp\u003ePatients from the Acupuncture Department of the Third Affiliated Hospital of Henan University of Chinese Medicine were screened according to the following inclusion and exclusion criteria. Inclusion Criteria: 1. Patients who met the diagnostic criteria for LDH in the \"Diagnostic Criteria for Traditional Chinese Medicine Diseases\" in China (low back pain accompanied by radiating leg pain). 2. Aged between 20 and 65 years old. 3. With symptoms lasting for 3 months or longer. 4. Visual Analog Scale (VAS) score\u0026thinsp;\u0026gt;\u0026thinsp;5 points. Exclusion Criteria: 1. Patients with vertebral fractures, spinal infections, or active inflammatory diseases within the past year. 2. Patients who were unable to complete the assessment. 3. Patients suffering from serious diseases (such as cancer, severe cardiovascular diseases like heart failure, advanced liver diseases including liver cirrhosis and liver failure, severe blood diseases like leukemia, and other life-threatening diseases). 4. Pregnant women, women planning to conceive, or lactating women. 5. Patients who had participated in other acupuncture therapies within the past month. Withdrawal Criteria: 1. Patients who did not follow the treatment protocol or received additional treatments not specified in the study during the treatment period. 2. Patients who experienced serious adverse reactions during the treatment process. 3. Patients who were unable to cooperate with the treatment for other reasons and voluntarily withdrew from the study.\u003c/p\u003e \u003cp\u003e \u003cb\u003eRandomization and blinding\u003c/b\u003e \u003c/p\u003e \u003cp\u003eRandomization was performed by a statistician not involved in the study using SPSS Statistics Version 26.0 (IBM). Random numbers were generated using the SPSS 26.0 software to create randomization cards, which were then placed in sealed opaque envelopes. The attending physician randomly distributed these envelopes to participants, who were assigned to the experimental group or the control group in a 1:1 ratio\u0026mdash;based on the randomization card information within the envelope. All efficacy assessments were conducted by a clinician unaware of the study design or patient allocation.\u003c/p\u003e\n\u003ch3\u003eIntervention\u003c/h3\u003e\n\u003cp\u003eAll participants in both the experimental and control groups received ST (comprised of controlled management of hypertension and hyperglycemia, supplemented with oral methylcobalamin, 500 \u0026micro;g three times daily). Both groups underwent a systematic treatment course lasting two weeks. Acupuncture procedures were performed by a licensed practitioner with over five years of clinical experience, while needle-knife therapy was conducted by a chief physician. Prior to the study, all therapists received standardized training focusing on precise localization of acupoints and needle-knife release techniques.\u003c/p\u003e \u003cp\u003eThe control group received acupuncture treatment four times per week (Monday-Thursday), with each session lasting 40 minutes. A complete treatment course consists of two weeks. The acupoint prescription was determined based on theories of Traditional Chinese Medicine and previous literature related to acupuncture for LDH\u003csup\u003e[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]\u003c/sup\u003e. Treatment sites were selected at the transverse processes of L3, L4, and L5 bilaterally, corresponding to the acupoints Shen shu (BL23), Da chang shu (BL25), and Qi hai shu (BL21), as well as bilaterally at the sacral foramina Ci liao (BL32) and Zhong liao (BL33). Acupoint nomenclature and localization followed the National Standard of the People\u0026rsquo;s Republic of China (GB/T 12346\u0026thinsp;\u0026minus;\u0026thinsp;2006). Detailed information regarding the locations of these acupoints can be found in Supplement2, e Fig.\u0026nbsp;\u003cspan refid=\"Fig1\" class=\"InternalRef\"\u003e1\u003c/span\u003e. All treatments were performed with participants in a prone position. Sterile, single-use stainless steel acupuncture needles (manufactured by Bangde Medical Equipment Co., Maanshan, China; specifications: 0.30 \u0026times; 25 mm, 0.30 \u0026times; 40 mm, and 0.30 \u0026times; 75 mm) were used. Needle gauge selection and acupuncture depth reference Supplement 2, eTable 1. For each acupoint, employ needling techniques such as lifting and thrusting, twisting, and rotating for one minute to induce the sensation of deqi, characterized by local soreness, numbness, distension, and pain. After achieving deqi, retain the needles for 30 minutes.\u003c/p\u003e \u003cp\u003eParticipants in the experimental group received needle-knife treatment four times per week (Monday-Thursday). Each treatment session targeted two specific acupoints. The entire intervention lasted two weeks as one treatment course. 1. Localization: The treatment location in the experimental group was the same as that in the control group. 2. Patient's position: Patients were placed in a prone position with the face resting in the face hole of the treatment table to ensure neck relaxation. The upper limbs were positioned alongside the body or allowed to hang freely from both sides of the table. 3. Disinfection: The skin around the treatment site was disinfected using iodophor-saturated cotton swabs, wiping in three concentric circles outward from the treatment point, ensuring no gaps are left. The disinfection area extended radially at least 10 cm from the site. A sterile aperture drape was then applied to expose the target area while maintaining an aseptic field. 4. Anesthesia: Local anesthesia was administered using a 0.5% lidocaine solution. A volume of 1 mL was injected per treatment site. During the procedure, patients were instructed to breathe normally. The needle was advanced slowly until bony contact was achieved. A retrograde injection technique was employed, distributing the 1 mL solution gradually from deep to superficial tissue. 5. The needle-knife therapy was performed using a Zhougong-brand Type I No. 3 needle-knife (1.0 mm \u0026times; 80 mm) The shape and specification of the needle-knife are shown in Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. The \u0026ldquo;three-step slow stratified needle insertion technique\u0026rdquo;\u003csup\u003e[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]\u003c/sup\u003e was employed to advance the needle-knife gradually to the bony surface. During needle-knife insertion, longitudinal cutting and transverse stripping were performed at the superficial, intermediate, and deep soft tissue. Emphasis was placed on soft tissue adhesions around the spinal vertebrae. A detailed description of the operational method is provided in Supplement 2, eTable 2.\u003c/p\u003e \u003cp\u003e \u003c/p\u003e \u003cp\u003e \u003cb\u003ePrimary outcome measure\u003c/b\u003e \u003c/p\u003e \u003cp\u003e1. Treatment efficacy rate; 2. The VAS score was used to evaluate the pain intensity. This scale, ranging from 0 to 10, defines 0 as \"no pain\" and 10 as \"the worst pain imaginable.\" During assessment, patients were presented with the unmarked side of the scale and asked to slide the cursor to a position corresponding to their perceived pain level. The physician then recorded the score based on the cursor\u0026rsquo;s position. 3. The ODI score was employed to evaluate functional impairment associated with LDH. Scores were classified as follows: 0%\u0026ndash;20% Mild dysfunction: daily activities largely maintained; 21%\u0026ndash;40% Moderate disability: some activities require assistance; 41%\u0026ndash;60% Severe disability: daily life significantly affected, often requiring medical intervention; 61%\u0026ndash;80% Crippling disability: most activities cannot be performed; 81%\u0026ndash;100% Complete disability: bedbound or fully dependent on others. The detailed ODI assessment form is presented in Supplement 2, e Fig.\u0026nbsp;\u003cspan refid=\"Fig2\" class=\"InternalRef\"\u003e2\u003c/span\u003e. VAS and ODI scores were evaluated at baseline, post-treatment, and at the 3-month follow-up.\u003c/p\u003e \u003cp\u003e \u003cb\u003eSecondary outcome measures\u003c/b\u003e \u003c/p\u003e \u003cp\u003e1. Lumbar Functional Mobility (LFM): A digital protractor was used to measure changes in lumbar flexion and bilateral lateral flexion in both groups before treatment, after one course of treatment, and at a 3-month follow-up to evaluate clinical efficacy. 2. Serum levels of TNF-α, IL-1β, and IL-6 were measured in both groups before treatment and after one course of treatment. Quantification was performed using enzyme-linked immunosorbent assay (ELISA). Detailed methodological procedures are described in Supplement 2, e Table\u0026nbsp;3.\u003c/p\u003e \u003cp\u003eAll treatment-related adverse events (AEs), including needle fainting, needle breakage, hematoma, and infection, were monitored and recorded. The severity of each AE (mild, moderate, or severe) was assessed by the investigators to determine whether treatment could be continued. This study reports the number and severity of all observed AEs.\u003c/p\u003e\n\u003ch3\u003eEfficacy Evaluation Criteria\u003c/h3\u003e\n\u003cp\u003eThe therapeutic effects were classified into four grades according to the subsequent criteria: 1. Cured: Complete resolution of lumbago and leg pain, straight leg raise (SLR) test\u0026thinsp;\u0026ge;\u0026thinsp;70\u0026deg;, and no restrictions in activities of daily living. 2. Markedly Effective: Significant pain reduction, substantial functional improvement, SLR test\u0026thinsp;\u0026ge;\u0026thinsp;60\u0026deg;, and the capacity to return to daily activities and work. 3. Effective: Moderate pain relief, partial functional recovery, and an increase in SLR. 4. Ineffective: Absence of improvement or exacerbation of symptoms, with persistent functional impairment.\u003c/p\u003e\n\u003ch3\u003eSample Size\u003c/h3\u003e\n\u003cp\u003eThe sample size for this study was carefully calculated based on prior clinical research regarding needle-knife therapy for LDH\u003csup\u003e[\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e and our clinical experience. The mean VAS score after treatment in the experiment group was 3.11, while that in the control group was 5.06. The standard deviation observed in the experiment group was 1.23, whereas the control group exhibited a standard deviation of 2.10. The study design incorporated two groups, each adhering to a 1:1 allocation ratio to ensure equitable representation. Employing the sample size formula n\u0026thinsp;=\u0026thinsp;2(Zα/2\u0026thinsp;+\u0026thinsp;Zβ)\u0026sup2; \u0026times; δ\u0026sup2;/(\u0026micro;t\u0026thinsp;+\u0026thinsp;\u0026micro;c-Δ)\u0026sup2;, with reference values α\u0026thinsp;=\u0026thinsp;0.05 and β\u0026thinsp;=\u0026thinsp;0.20, the calculated sample size was 35. A total of 70 patients were required across both groups. Accounting for potential attrition, a total of 74 patients were enrolled.\u003c/p\u003e \u003cdiv id=\"Sec8\" class=\"Section2\"\u003e \u003ch2\u003e\u003cb\u003eStatistical Analysis\u003c/b\u003e\u003c/h2\u003e \u003cp\u003eData processing and analysis were performed using IBM SPSS Statistics 26 software. Normally distributed continuous variables are presented as mean\u0026thinsp;\u0026plusmn;\u0026thinsp;standard deviation (x\u0026thinsp;\u0026plusmn;\u0026thinsp;s). Independent samples t-tests were used for between-group comparisons, and paired samples t-tests were used for within-group comparisons at different time points. Non-normally distributed quantitative data are expressed as median [M(P25,P75)]. The Wilcoxon signed-rank test or Friedman test was used for intergroup and intragroup comparisons. Categorical data were analyzed using the chi-square test. \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05 indicated statistically significant differences.\u003c/p\u003e \u003c/div\u003e"},{"header":"Results","content":"\u003cp\u003e\u003cstrong\u003ePatients\u003c/strong\u003e \u003cstrong\u003eand\u003c/strong\u003e \u003cstrong\u003echaracteristics\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBetween February 15, 2025, and June 15, 2025, a total of 74 eligible patients were enrolled, including 32 females and 42 males. Among them, 70 patients (95%) completed the intervention and the 3-month follow-up, consisting of 30 females (42.8%) and 40 males (57.2%), with a mean (SD) age of 44.26 (8.35) years. The participant flow diagram is presented in Figure 3. Baseline demographic and clinical characteristics of the included patients are summarized in\u0026nbsp;Table 1.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003ePrimary outcome\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTable 2 provides a comparative analysis of the primary outcomes within both groups pre- and post-treatment, along with follow-up changes in VAS and ODI scores for both groups. A total of 70 patients completed all assessments. Following one treatment cycle, the experiment group exhibited a mean (SD) VAS score of 2.25 (1.38), representing a 4.5 (0.15) reduction from baseline. The control group demonstrated a mean (SD) post-treatment VAS score of 3.41 (1.22), with a reduction of 2.91 (0.58) from baseline. The disparity is statistically significant (\u003cem\u003eP\u003c/em\u003e\u0026lt;0.05). The experiment group's mean (SD) ODI score was 16.35 (2.55), a decrease of 24.3 (0.66) from baseline, whereas the control group's score was 20.13 (2.18), a decrease of 21.38 (0.25) from baseline. The disparity is statistically significant (\u003cem\u003eP\u003c/em\u003e\u0026lt;0.05). The experiment group showed a greater reduction in VAS score by 1.16 points and in ODI score by 3.78 points compared to the control group post-treatment (\u003cem\u003eP\u003c/em\u003e\u0026lt;0.05). The overall effective rate in the experiment group was 90%, and in the control group, it was 87%. At the 3-month follow-up, both groups showed further improvement in VAS and ODI scores compared to post-treatment scores, with the experiment group demonstrating greater improvement (\u003cem\u003eP\u003c/em\u003e\u0026lt;0.05). The specific score changes before and after treatment are shown in Figure 4.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eSecondary outcome\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eRegarding LFM, the experiment group demonstrated higher scores compared to the control group across all components, with notable differences in lumbar flexion 2.81 (-0.12), left lateral flexion 0.70 (0.24), and right lateral flexion 0.41 (0.06). The disparity is statistically significant (\u003cem\u003eP\u003c/em\u003e\u0026lt;0.05). In terms of\u0026nbsp;inflammatory markers, including TNF-α, IL-1β, and IL-6, the experiment group exhibited greater reductions than the control group: TNF-α: -0.18 (-0.22); IL-1β: -0.13 (-0.05); IL-6: -0.47 (-0.28). At the 3-month follow-up, both groups showed further improvements in lumbar flexion and bilateral lateral flexion compared to post-treatment measurements. The degree of improvement was greater in the experiment group than in the control group (\u003cem\u003eP\u0026nbsp;\u003c/em\u003e\u0026lt; 0.05). The specific score changes before and after treatment are shown in\u0026nbsp;Figure 4.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAdverse event\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn the experimental group, one patient developed a subcutaneous hematoma after treatment, which resolved following brief local massage. In the control group, two patients experienced mild needle syncope (fainting during acupuncture) during the first acupuncture session, presenting with dizziness, nausea, and vomiting. These patients were immediately placed in a supine position with their legs elevated to promote venous return and were given warm sugar water to drink. Their symptoms resolved completely after 5 minutes of rest.\u003c/p\u003e\n\n\n\n\n\n\n\n\n"},{"header":"Discussion","content":"\u003cp\u003eThis single-center randomized controlled trial demonstrated that a 14-day needle-knife lumbosacral therapy significantly reduced patients' VAS and ODI scores while also improving LFM. Compared to the control group (AT), the clinical efficacy was notably better (\u003cem\u003eP\u003c/em\u003e\u0026lt;0.05). A three-month follow-up revealed that improvements in VAS, ODI, and LFM persisted at the end of the follow-up period, indicating that needle knife lumbosacral therapy has long-term effects. Additionally, no severe reactions were reported during the trial, suggesting that needle knife lumbosacral therapy is a safe and effective treatment.\u003c/p\u003e\u003cp\u003eIn this study, the within-group changes with a large effect size in pain intensity exceeded the minimal clinically important difference (\u0026gt; 10%) for VAS, indicating clinically meaningful improvements\u003csup\u003e[19]\u003c/sup\u003e.\u0026nbsp;These results suggest that needle knife lumbosacral therapy effectively reduces localized pain in LDH patients, with sustained therapeutic effect throughout the 3-month period.\u0026nbsp;The similar findings have been found in the previous studies\u0026nbsp;regarding\u0026nbsp;the positive role of\u0026nbsp;the needle-knife therapy.\u0026nbsp;A single-blind randomized controlled trial has demonstrated that needle-knife therapy provides more significant short- and long-term pain reduction and recovery of local dysfunction compared with acupuncture therapy\u003csup\u003e[20]\u003c/sup\u003e.Currently, needle-knife therapy for LDH primarily focuses on the release of tension in soft tissue\u0026nbsp;surrounding the spinal column. For example, Lin et al. have indicated that\u0026nbsp;release\u0026nbsp;targeting\u0026nbsp;the transverse processes of L\u003csub\u003e3\u003c/sub\u003e, L\u003csub\u003e4\u003c/sub\u003e, and L\u003csub\u003e5\u003c/sub\u003e is a key aspect of this therapy\u003csup\u003e[21]\u003c/sup\u003e Meanwhile, Liu et al. have emphasized the importance\u0026nbsp;of\u0026nbsp;releasing\u0026nbsp;the ligamentum\u0026nbsp;flavum during needle-knife therapy\u003csup\u003e[22]\u003c/sup\u003e. Building on previous research, this study further emphasized treatment of the sacroiliac joint. The results revealed that needle-knife lumbosacral therapy achieved more significant improvements in both pain relief and functional recovery compared to previous studies. The results of this study are as follows: Regarding VAS scores, prior research indicated an intra-group reduction from 6.17 to 2.48\u003csup\u003e[23]\u003c/sup\u003e. In the present study, the NKT group demonstrated a 4.5-point reduction in VAS scores within the group. For ODI scores, previous studies reported a 15-point reduction from baseline. Our findings indicate that the intergroup difference in the NKT group post-treatment was 4 points, with a reduction of 24.3 points from baseline. These results not only confirmed the therapeutic efficacy of needle-knife intervention in managing LDH but also demonstrated the clinical advantage of needle-knife lumbosacral therapy over conventional needle-knife therapy.\u003c/p\u003e\u003cp\u003eThe therapeutic mechanisms underlying needle-knife intervention in LDH operate through four interconnected pathways. Structurally, precise percutaneous release of paravertebral soft tissue constraints alleviates mechanical nerve root compression by disrupting adhesive scar tissue and myofascial contractures\u003csup\u003e[24]\u003c/sup\u003e. At the cellular level, mechanical stimulation of nociceptive fibers triggers TRPV1 channel opening, initiating intracellular calcium influx that subsequently dampens NF-κB nuclear translocation and downstream pro-inflammatory gene transcription—manifesting as reduced circulating IL-6 and TNF-α alongside elevated IL-10\u003csup\u003e\u0026nbsp;[25]\u003c/sup\u003e. Biomechanically, capsular release of zygapophyseal joints and intertransverse ligament mobilization corrects segmental rotational dysfunction (3°–5°) and pelvic obliquity (2°–3°), reestablishing lumbopelvic-lower extremity kinetic chain alignment\u003csup\u003e[26]\u003c/sup\u003e. Neurochemically, paraspinal afferent stimulation engages spinal cord μ-opioid receptor populations and precipitates β-endorphin secretion (2–3-fold elevation), generating prolonged antinociception that reaches maximal intensity at 24 hours post-procedure and persists 50% beyond conventional acupuncture duration\u003csup\u003e[27]\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eLDH is closely related to chronic soft tissue injuries\u003csup\u003e[28]\u003c/sup\u003e. In the early stage of LDH, it mostly presents as multifidus muscle atrophy and adhesion of the thoracolumbar fascia, resulting in instability of the lumbar segments, microcracks in the annulus fibrosus, and gradually accumulating micro-damage\u003csup\u003e[29]\u003c/sup\u003e. Subsequently, the sacrospinous ligament and the gluteus maximus undergo compensatory hypertrophy to maintain the stability of the lumbar segments, and the additional tension is continuously transmitted through the fascial chain to the intervertebral disc\u003csup\u003e[30]\u003c/sup\u003e. Once the compensatory muscle groups become fatigued or form scar contractures, the accumulated stress in the intervertebral disc will exceed the degeneration threshold, thereby causing the nucleus pulposus to protrude\u003csup\u003e[31]\u003c/sup\u003e .Therefore, during the treatment, needle-knife therapy emphasizes the release of tension in soft tissues surrounding the spine to restore the dynamic biomechanical balance of the spine\u003csup\u003e[32]\u003c/sup\u003e.\u003c/p\u003e\u003cp\u003eBased on extensive clinical experience, our team has proposed the “Iceberg Theory”\u003csup\u003e[33]\u003c/sup\u003e of chronic soft tissue injury (Figure 5). We believe that most chronic soft tissue injuries evolve gradually. As the patient's physiology adapts to the localized pathological changes, the clinical presentation becomes less prominent. Consequently, chronic soft tissue injury can be divided into\u0026nbsp;visible and hidden parts. The “tip of the iceberg” signifies the most symptomatic region—the area eliciting the\u0026nbsp;greatest discomfort or functional impairment—and is readily apparent to clinicians. Submerged “beneath the waterline are subclinical soft tissue injuries, which may be vaguely perceived or entirely unnoticed by the patient and often missed by physicians. These concealed injuries represent the continuous progression of the disease.\u0026nbsp;For diseases related to soft tissue injuries, the covert component is the primary target of clinical intervention. Just as “the center of gravity of an iceberg lies below the water level rather than above it,” the core pathogenesis often lies beyond the patient's overt symptoms. This necessitates a focus beyond superficial manifestations to address the root cause of the disease, identifying the true source of the patient's pain.\u003c/p\u003e\u003cp\u003eThe “needle-knife\u0026nbsp;lumbosacral therapy” is established based on this rationale.\u0026nbsp;The sacral dorsal root ganglion (DRG) is a key sensitization center for chronic low back pain and lower extremity radicular pain\u003csup\u003e[34]\u003c/sup\u003e. Chronic inflammatory or mechanical stimulation of the surrounding soft tissues, including the multifidus muscle, sacrospinalis muscle, and sacroiliac ligament, can result in sustained DRG activation, contributing to the chronicity and refractoriness of low back pain symptoms\u003csup\u003e[35]\u003c/sup\u003e. Consequently, soft tissue release in the sacral region can reduce mechanical sensitization of the DRG, thereby mitigating low back pain symptoms.\u003c/p\u003e\u003cp\u003eThis study has several strengths.\u0026nbsp;the use of blinding in the trial design and execution, which improved the reliability and validity of the results. Standardized training for practitioners before the intervention, along with standardization for manipulation techniques and needling depth, minimized operator-dependent variability and enhanced the evidence's quality. Moreover, a comprehensive battery of outcome measures, such as pain scores, dysfunction assessments, range of motion, and inflammatory markers, enabled a thorough evaluation of the needle-knife's clinical efficacy in treating LDH.\u003c/p\u003e\u003cp\u003eHowever, several limitations should be acknowledged. The unique characteristics of needle-knife and acupuncture therapies precluded the blinding of participants and practitioners, potentially introducing performance bias. Furthermore, the three-month follow-up period restricted the assessment of long-term effects and the durability of the intervention. Finally, the relatively small sample size and single-center recruitment may limit the generalizability of the results. Future research should consider conducting multi-sample and multi-center clinical studies to ensure the applicability of the results to a wider range of patients with LDH.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe study's results indicate that lumbosacral needle-knife therapy is effective in reducing low back pain and improving local dysfunction in individuals with LDH. These findings support its potential for wider clinical implementation.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cdiv class=\"DefinitionList\"\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eLDH\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eLumbar disc herniation\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eVAS\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eVisual analog scale\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eODI\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eOswestry Disability Index\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eNKT\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eNeedle knife therapy AT\u0026thinsp;=\u0026thinsp;acupuncture therapy\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003cdiv class=\"DefinitionListEntry\"\u003e \u003cdiv class=\"Term\"\u003eLFM\u003c/div\u003e \u003cdiv class=\"Description\"\u003e \u003cp\u003eLumbar Functional Mobility\u003c/p\u003e \u003c/div\u003e \u003c/div\u003e \u003c/div\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eEthics approval\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis retrospective study was conducted as part of the [XXX] project, which was approved by the Institutional Review Board of [XXX] (Approval No. [2025-HL003]). We have also registered with the International Traditional Medicine Clinical Trial Registration Platform (https://itmctr.ccebtcm.org.cn/mgt/dashboard ).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent to participate\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll participants provided written informed consent under the principles of the Declaration of Helsinki.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis work was supported by the project of the Henan Province Chinese medicine research project (2024ZY2095).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConflict of interest\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe author declares no competing interests in this work. \u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eYiming Zhang and Ruiguo Li participated in the design of this study . Xiaohong Zhang and Zhanyou Wang drafted the manuscript. Ziwei Zhang, Huanhuan Xu and Xiaofan Li critically revised the manuscript for important intellectual content. All authors read and approved the final manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eHincapi\u0026eacute; CA, Kroismayr D, Hofstetter L et al (2025) Incidence of and risk factors for lumbar disc herniation with radiculopathy in adults: a systematic review. 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Anesthesiology Pain Med 11(2):e113020. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.5812/aapm.113020\u003c/span\u003e\u003cspan address=\"10.5812/aapm.113020\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e \u003cli\u003e\u003cspan\u003eAbd-Elsayed A, Vardhan S, Aggarwal A et al (2024) Mechanisms of Action of Dorsal Root Ganglion Stimulation. Int J Mol Sci 25(7):3591. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.3390/ijms25073591\u003c/span\u003e\u003cspan address=\"10.3390/ijms25073591\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"},{"header":"Tables","content":"\u003cp\u003e\u003cstrong\u003eTable 1. Baseline Demographic and Clinical Characteristics of the Included Participants\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"627\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eCharacteristic\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003eTotal sample (n = 74)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003eNKT (n = 37)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e\u0026nbsp;AT(n = 37)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003ePvalue\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eFemale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e32 (43.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e14 (37.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e18 (45.71)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026gt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eMale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e42 (56.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e23(62.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e19 (54.29)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eSmoker, No. (%)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e45 (60.8)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e25 (67.6)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e20 (54.1)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026gt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eYes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e29 (39.2)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e12 (32.4)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e17 (45.9)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026gt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eAge, mean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e44.26 (8.35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e43.76 (9.23)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e44.76 (7.39)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026gt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eBMI, mean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e22.23 (14.06)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e22.40 (12.41)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e22.05 (15.59)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026gt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eDuration of illness (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e3.34 (3.05)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e3.98 (3.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e2.70 (2.5)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026gt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eVAS, mean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e6.53 (1.67)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e6.75 (1.53)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e6.32 (1.80)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026gt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eODI, mean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e41.08 (2.87)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e40.65 (3.21)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e41.51 (2.43)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eLFM (lumbar flexion) , mean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e46.84 (7.28)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e45.42 (8.63)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e48.27 (5.30)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eLFM (Left lateral flexion), mean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e22.56 (3.31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e21.27 (3.53)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e23.85 (3.10)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eLFM (right lateral flexion), mean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e23.57 (3.0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e23.51 (2.15)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e23.63 (3.67)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026gt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eBlood serum levels of, TNF - \u0026alpha;/ng \u0026middot;L - 1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e8.87 (1.51)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e8.54 (1.35)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e9.21 (1.60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eBlood serum levels of,\u0026nbsp;IL - 6/ng \u0026middot;L - 1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e14.51 (2.19)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e14.51 (2.23)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e13.50 (2.09)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31.3694%;\"\u003e\n \u003cp\u003eBlood serum levels of,\u0026nbsp;IL - 1\u0026beta;/ng \u0026middot;L - 1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18.3121%;\"\u003e\n \u003cp\u003e6.51 (0.42)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20.3822%;\"\u003e\n \u003cp\u003e6.60 (0.50)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21.3376%;\"\u003e\n \u003cp\u003e6.43 (0.31)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 8.59873%;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eAbbreviations: NKT: Needle knife therapy, AT: Acupuncture therapy，\u0026nbsp;VAS:\u0026nbsp;Visual Analogue Scale,\u0026nbsp;ODI：Oswestry Disability Index, LFM: Lumbar Functional Mobility, BMI:Body Mass Index\u003c/p\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"106%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTable\u0026nbsp;2 Treatment\u0026nbsp;Effects\u0026nbsp;of NKT\u0026nbsp;and\u0026nbsp;AT\u0026nbsp;group one course of treatment\u0026nbsp;and\u0026nbsp;3\u0026nbsp;months\u0026nbsp;of\u0026nbsp;Follow-Up\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003eOutcome\u0026nbsp;assessment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"4\" valign=\"top\" style=\"width: 77px;\"\u003e\n \u003cp\u003eNKT group(n=35) \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; \u0026nbsp; AT group(n=35)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003eScore after treatment\u0026nbsp;\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;mean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003ePvalue\u003c/p\u003e\n \u003cp\u003eIntra-group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003eScore after treatment\u003c/p\u003e\n \u003cp\u003emean (SD)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003ePvalue\u003c/p\u003e\n \u003cp\u003eInter-group\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003eVAS\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003ePost treatment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e2.25(1.38)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e3.41(1.22)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003eFollow-up\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e1.93(0.55)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e2.36(0.48)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003eODI\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003ePosttreatment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e16.35(2.55)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e20.13(2.18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003eFollow-up\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e13.17(1.72)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e15.06(1.29)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003eEffective rate\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003ePosttreatment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e90%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e87%\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003eLFM (lumbar flexion)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003ePosttreatment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e75.39(5.36)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e72.58(5.48)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003eFollow-up\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e79.16(2.57)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e76.21(2.13)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003eLFM (Left lateral flexion)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003ePosttreatment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e26.35(3.18)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e25.65(1.62-2.45)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003eFollow-up\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e27.67(3.38)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e26.93(2.79)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003eLFM (right lateral flexion)\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003ePosttreatment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e26.74(2.95)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e26.33(2.71)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003eFollow-up\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e28.05(2.34)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e27.65(2.28)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003eBlood serum levels of, TNF - \u0026alpha;/ng \u0026middot;L \u0026ndash; 1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003ePosttreatment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e3.75(0.60)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e3.93(0.82)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003eBlood serum levels of,\u0026nbsp;IL - 6/ng \u0026middot;L \u0026ndash; 1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003ePosttreatment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e3.35(0.47)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e3.82(0.75)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd colspan=\"5\" valign=\"top\" style=\"width: 100px;\"\u003e\n \u003cp\u003eBlood serum levels of,\u0026nbsp;IL - 1\u0026beta;/ng \u0026middot;L \u0026ndash; 1\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003ePosttreatment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e3.52(0.48)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 25px;\"\u003e\n \u003cp\u003e3.65(0.53)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 13px;\"\u003e\n \u003cp\u003e\u0026lt;0.05\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eTable 3\u0026nbsp;CONSORT 2025 checklist item description\u003c/p\u003e\n\u003ctable border=\"0\" cellspacing=\"0\" cellpadding=\"0\" width=\"1138\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eSection/topic\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003eNo\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eCONSORT 2025 checklist item description\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003eReported on page no.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 926px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eTitle and abstract\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eTitle and structured abstract\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e1a\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eIdentification as a randomised trial\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage4 line 88\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e1b\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eStructured summary of the trial design, methods, results, and conclusions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage2\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 926px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eOpen science\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eTrial registration\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eName of trial registry, identifying number (with URL) and date of registration\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage4 line 102\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eProtocol and statistical analysis plan\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eWhere the trial protocol and statistical analysis plan can be accessed\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage5 line 123\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eData sharing\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eWhere and how the individual de-identified participant data (including data dictionary), statistical code and any other materials can be accessed\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage 5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eFunding and conflicts of interest\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e5a\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eSources of funding and other support (eg, supply of drugs), and role of funders in the design, conduct, analysis and reporting of the trial\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage14 line379\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e5b\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eFinancial and other conflicts of interest of the manuscript authors\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage 13\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 926px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eIntroduction\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eBackground and rationale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eScientific background and rationale\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd style=\"width: 180px;\"\u003e\n \u003cp\u003eObjectives\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eSpecific objectives related to benefits and harms\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage13\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 926px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eMethods\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003ePatient and public involvement\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eDetails of patient or public involvement in the design, conduct and reporting of the trial\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage9 line231\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eTrial design\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eDescription of trial design including type of trial (eg, parallel group, crossover), allocation ratio, and framework (eg, superiority, equivalence, non-inferiority, exploratory)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage 4-6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eChanges to trial protocol\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eImportant changes to the trial after it commenced including any outcomes or analyses that were not prespecified, with reason\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage9\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eTrial setting\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eSettings (eg, community, hospital) and locations (eg, countries, sites) where the trial was conducted\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage4 line106\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eEligibility criteria\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e12a\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eEligibility criteria for participants\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage4\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e12b\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eIf applicable, eligibility criteria for sites and for individuals delivering the interventions (eg, surgeons, physiotherapists)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage6 line137\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eIntervention and comparator\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eIntervention and comparator with sufficient details to allow replication. If relevant, where additional materials describing the intervention and comparator (eg, intervention manual) can be accessed\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage6-7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eOutcomes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e14\u003c/p\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003ePrespecified primary and secondary outcomes, including the specific measurement variable (eg, systolic blood pressure), analysis metric (eg, change from baseline, final value, time to event), method of aggregation (eg, median, proportion), and time point for each outcome\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage5-7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eHarms\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e15\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eHow harms were defined and assessed (eg, systematically, non-systematically)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage5 line123\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eSample size\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e16a\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eHow sample size was determined, including all assumptions supporting the sample size calculation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage8 line212\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e16b\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eExplanation of any interim analyses and stopping guidelines\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage8 line199\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eRandomisation:\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003e\u0026emsp;Sequence generation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e17a\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eWho generated the random allocation sequence and the method used\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage5 line123\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e17b\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eType of randomisation and details of any restriction (eg, stratification, blocking and block size)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eReported on page no.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003e\u0026emsp;Allocation concealment mechanism\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e18\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eMechanism used to implement the random allocation sequence (eg, central computer/telephone; sequentially numbered, opaque, sealed containers), describing any steps to conceal the sequence until interventions were assigned\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003e\u0026emsp;Implementation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e19\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eWhether the personnel who enrolled and those who assigned participants to the interventions had access to the random allocation sequence\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eBlinding\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e20a\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eWho was blinded after assignment to interventions (eg, participants, care providers, outcome assessors, data analysts)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage4 line105\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e20b\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eIf blinded, how blinding was achieved and description of the similarity of interventions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"4\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eStatistical methods\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e21a\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eStatistical methods used to compare groups for primary and secondary outcomes, including harms\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e21b\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eDefinition of who is included in each analysis (eg, all randomised participants), and in which group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage5\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e21c\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eHow missing data were handled in the analysis\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e21d\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eMethods for any additional analyses (eg, subgroup and sensitivity analyses), distinguishing prespecified from post hoc\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage8-9\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"bottom\" style=\"width: 926px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eParticipant flow, including flow diagram\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e22a\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eFor each group, the numbers of participants who were randomly assigned, received intended intervention, and were analysed for the primary outcome\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage9-10\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e22b\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eFor each group, losses and exclusions after randomisation, together with reasons\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage9-10\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eRecruitment\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e23a\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eDates defining the periods of recruitment and follow-up for outcomes of benefits and harms\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage9-10\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e23b\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eIf relevant, why the trial ended or was stopped\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage9 line264\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd rowspan=\"2\" valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eIntervention and comparator delivery\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e24a\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eIntervention and comparator as they were actually administered (eg, where appropriate, who delivered the intervention/comparator, how participants adhered, whether they were delivered as intended (fidelity))\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage6\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e24b\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eConcomitant care received during the trial for each group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage7\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eBaseline data\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e25\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eA table showing baseline demographic and clinical characteristics for each group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage9 line238\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eNumbers analysed,\u003c/p\u003e\n \u003cp\u003eoutcomes and estimation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e26\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eFor each primary and secondary outcome, by group:\u003c/p\u003e\n \u003cp\u003e● the number of participants included in the analysis\u003c/p\u003e\n \u003cp\u003e● the number of participants with available data at the outcome time point\u003c/p\u003e\n \u003cp\u003e● result for each group, and the estimated effect size and its precision (such as 95% confidence interval)\u003c/p\u003e\n \u003cp\u003e● for binary outcomes, presentation of both absolute and relative effect size\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage10\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eHarms\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e27\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eAll harms or unintended events in each group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage10\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eAncillary analyses\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e28\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eAny other analyses performed, including subgroup and sensitivity analyses, distinguishing pre-specified from post hoc\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage9\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd colspan=\"3\" valign=\"top\" style=\"width: 926px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eDiscussion\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eInterpretation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e29\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eInterpretation consistent with results, balancing benefits and harms, and considering other relevant evidence\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage10-11\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 104px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 180px;\"\u003e\n \u003cp\u003eLimitations\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 57px;\"\u003e\n \u003cp\u003e30\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 690px;\"\u003e\n \u003cp\u003eTrial limitations, addressing sources of potential bias, imprecision, generalisability, and, if relevant, multiplicity of analyses\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 107px;\"\u003e\n \u003cp\u003epage12\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eCitation: Hopewell S, Chan AW, Collins GS, Hr\u0026oacute;bjartsson A, Moher D, Schulz KF, et al. CONSORT 2025 Statement: updated guideline for reporting randomised trials. BMJ. 2025; 388:e081123. https://dx.doi.org/10.1136/bmj-2024-081123\u0026nbsp;\u003cbr\u003e\u0026nbsp;\u0026copy; 2025 Hopewell et al. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (https://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.\u003c/p\u003e\n\u003cp\u003e*We strongly recommend reading this statement in conjunction with the CONSORT 2025 Explanation and Elaboration and/or the CONSORT 2025 Expanded Checklist for important clarifications on all the items. We also recommend reading relevant CONSORT extensions. See www.consort-spirit.org.\u003c/p\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"european-spine-journal","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"esjo","sideBox":"Learn more about [European Spine Journal](http://link.springer.com/journal/586)","snPcode":"586","submissionUrl":"https://submission.springernature.com/new-submission/586/3","title":"European Spine Journal","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false},"keywords":"Lumbosacral Co-Treatment, Needle-Knife, Lumbar Disc Herniation, Clinical Observation, Controlled Trial","lastPublishedDoi":"10.21203/rs.3.rs-9323687/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-9323687/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003ch2\u003eBackground\u003c/h2\u003e \u003cp\u003eLumbar disc herniation (LDH) is a common spinal disorder causing significant pain and dysfunction. Traditional acupuncture is a widely used non-pharmacological treatment for LDH. Recently, needle-knife therapy has emerged as a potential alternative.\u003c/p\u003e\u003ch2\u003eObjective\u003c/h2\u003e \u003cp\u003eExploring the clinical efficacy of needle-knife lumbosacral therapy for LDH and comparing its advantages with conventional acupuncture therapy.\u003c/p\u003e\u003ch2\u003eMethods\u003c/h2\u003e \u003cp\u003eA total of 74 patients with LDH were enrolled and randomly assigned to either the experimental group (n\u0026thinsp;=\u0026thinsp;37), receiving needle-knife lumbosacral therapy, or the control group (n\u0026thinsp;=\u0026thinsp;37), treated with conventional acupuncture, with the same treatment location in both groups. Recruitment occurred between February 15, 2025, and June 15, 2025, with the final follow-up conducted on October 18, 2025. Both groups underwent a two-week therapeutic intervention. Outcome measures included treatment efficacy rate, Visual Analog Scale (VAS) scores, Oswestry Disability Index (ODI), and lumbar functional mobility (LFM), assessed at baseline, post-treatment, and three-month follow-up. Additionally, serum levels of inflammatory cytokines were measured. Adverse events were monitored throughout the treatment period.\u003c/p\u003e\u003ch2\u003eResults\u003c/h2\u003e \u003cp\u003eThe total effective rate in the experimental group was significantly higher than that in the control group (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05). Both groups demonstrated reductions in VAS and ODI scores post-treatment, with the experimental group displaying lower values [VAS score: -1.16 (0.16); \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05; ODI score: -3.78 (0.37); \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05]. Serum concentrations of inflammatory biomarkers were attenuated in both groups, with more reductions observed in the experimental group [TNF-α: -0.18 (-0.22); \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05; IL-1β: -0.13 (-0.05); P\u0026thinsp;\u0026lt;\u0026thinsp;0.05; IL-6: -0.47 (-0.28); \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05]. LFM scores improved in both groups, with greater improvement in the experimental group [lumbar flexion: 2.81 (-0.12); \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05; left lateral flexion: 0.70 (0.24); \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05; right lateral flexion: 0.41 (0.06); \u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05]. At the 3-month follow-up, both groups showed further improvements in VAS, ODI, and LFM scores, with greater improvements in the experimental group (\u003cem\u003eP\u003c/em\u003e\u0026thinsp;\u0026lt;\u0026thinsp;0.05). No serious adverse events were reported.\u003c/p\u003e\u003ch2\u003eConclusion\u003c/h2\u003e \u003cp\u003eTwo weeks of needle-knife lumbosacral therapy for LDH has a good therapeutic effect in relieving patients' lumbar pain and improving their lumbar mobility disorders. Moreover, the therapeutic effect is superior to that of traditional acupuncture treatment.\u003c/p\u003e","manuscriptTitle":"Needle-knife lumbosacral therapy for Lumbar Disc herniation: A Single-Center, Multi-Sample, Single-Blind Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2026-04-21 14:59:21","doi":"10.21203/rs.3.rs-9323687/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"reviewersInvited","content":"","date":"2026-04-13T17:55:49+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2026-04-09T21:21:35+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2026-04-09T05:57:52+00:00","index":"","fulltext":""},{"type":"submitted","content":"European Spine Journal","date":"2026-04-05T02:35:36+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"european-spine-journal","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"esjo","sideBox":"Learn more about [European Spine Journal](http://link.springer.com/journal/586)","snPcode":"586","submissionUrl":"https://submission.springernature.com/new-submission/586/3","title":"European Spine Journal","twitterHandle":"","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"Springer Hybrid","inReviewEnabled":true,"inReviewRevisionsEnabled":false}}],"origin":"","ownerIdentity":"2ae6318e-dee1-4b57-ac54-3f91d840dd72","owner":[],"postedDate":"April 21st, 2026","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2026-04-21T14:59:21+00:00","versionOfRecord":[],"versionCreatedAt":"2026-04-21 14:59:21","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-9323687","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-9323687","identity":"rs-9323687","version":["v1"]},"buildId":"XKTyCvWXoU3ODBz1xrDgd","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}