Effect of Xuehai Acupoint (SP10) Herbal Application on Swelling and Analgesia in Ankle Fracture Patients A Randomized Controlled Trial

Effect of Xuehai Acupoint (SP10) Herbal Application on Swelling and Analgesia in Ankle Fracture Patients A 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 Effect of Xuehai Acupoint (SP10) Herbal Application on Swelling and Analgesia in Ankle Fracture Patients A Randomized Controlled Trial Xiaoyu Zhou, Yong Wang, Qiang Yu, Daihong Ji, Lin Guo, Jialu Xiao This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-6639301/v1 This work is licensed under a CC BY 4.0 License Status: Posted Version 1 posted You are reading this latest preprint version Abstract Objective ​ To evaluate the clinical efficacy of herbal patch application at Xuehai acupoint (SP10) in reducing perioperative swelling and alleviating pain in patients undergoing ankle fracture surgery. ​ Methods ​ This randomized controlled trial enrolled 80 patients with ankle fractures admitted to the Department of Orthopedic Trauma at Dalian University Affiliated Zhongshan Hospital between July 2020 and September 2022. Participants were randomly divided into control (n=40) and intervention (n=40)groups. The control group received standard interventions, including intermittent cold therapy, limb elevation, and functional exercises. The intervention group received additional treatment with a customized traditional chinese herbal patch applied to SP10 ,which containing Spatholobus stem (Jixueteng), Atractylodes rhizome (Cangzhu), Chuanxiong rhizome (Chuanxiong), and Corydalis tuber (Yanhusuo) . Outcomes including edema severity, NRS pain scores, ankle function (AOFAS score), and rescue NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) usage were assessed at postoperative days 1, 3, and 5. ​ Results ​ The intervention group demonstrated significantly reduced swelling (p<0.05) and lower pain scores (p<0.05) compared to the control group. Edema volume decreased from 4.68±0.66 cm (baseline) to 0.72±0.29 cm (day 5) in the herbal patch group versus 4.80±0.60 cm to 1.37±0.44 cm in controls, with faster edema resolution (80.23±6.33 vs. 96.63±4.78 hours, p<0.001). NRS pain scores improved markedly in the intervention group (day 5: 1.13±1.13 vs. 2.64±1.03, p0.05). No significant differences emerged in rescue NSAID usage (p>0.05), and both protocols were well-tolerated without severe adverse events. ​ Conclusion ​ Herbal patch therapy at Xuehai acupoint (SP10) effectively mitigates post-fracture edema and pain, likely through its meridian-activating and stasis-resolving properties. This non-invasive approach, avoiding direct application to the injured site, offers a safe and practical adjunct to conventional perioperative care. While promising, this pilot study warrants validation through larger-scale trials with extended follow-up periods to confirm long-term benefits. Ankle Fractures Acupuncture Points Xuehai (SP10) Herbal Medicine Edema Pain Figures Figure 1 Figure 2 Figure 3 Figure 4 Figure 5 1. Introduction Ankle fractures account for approximately 9% of all fractures and predominantly affect physically active adults and elderly individuals with osteoporosis [ 1 ] . As one of the most prevalent intra-articular fractures in orthopedic practice [ 2 ] , ankle fractures trigger the release of inflammatory mediators and fluid extravasation due to traumatic injury or iatrogenic surgical trauma, resulting in perilesional soft tissue edema, pain, and functional impairment [ 3 ] . Preoperative pain, a well-established independent predictor of postoperative pain and prognosis [ 4 ] , amplifies nociceptive signaling through central sensitization mechanisms. This phenomenon fosters pain memory formation, reduces pain tolerance, and compromises patient compliance with early postoperative rehabilitation [ 4 ] . Furthermore, persistent pain activates inflammatory pathways, elevating pro-inflammatory cytokines (e.g., IL-6, TNF-α) that delay wound healing and promote aberrant tissue repair, thereby increasing risks of hypertrophic scarring [ 5 ] . Perioperative soft tissue complications, particularly preoperative edema, significantly influence long-term functional outcomes following ankle fracture surgery [ 6 ] . Tissue edema increases local tension, restricts surgical maneuverability, and elevates intraoperative soft tissue injury risks [ 7 ] . Prolonged swelling also impairs microcirculation, reducing oxygen and nutrient delivery to incision margins and extending wound healing timelines [ 8 ] . Notably, pain and edema exhibit synergistic interactions: severe pain exacerbates muscle spasms, further hindering venous return and aggravating swelling, while elevated tissue tension from edema activates nociceptors, perpetuating a vicious "pain-edema-pain" cycle [ 5 ] . This pathophysiological interplay not only delays functional recovery but also adversely impacts psychological well-being and rehabilitation engagement, ultimately compromising long-term joint outcomes [ 9 ] . Current clinical protocols for edema management—such as rest, ice, compression, elevation (RICE), and functional exercises—yield suboptimal recovery rates [ 10 ] . Recent advancements, including the PEACE (Protection, Education, Avoidance of Anti-Inflammatories, Compression, Elevation) & LOVE (Load Optimization, Vascularization, Exercise) principles proposed by Dubois and Esculier [ 11 ] , advocate phased management combining acute-phase protection with progressive functional rehabilitation. However, these approaches lack targeted anti-inflammatory strategies. Traditional Chinese Medicine (TCM) posits that meridians and acupoints intricately connect visceral organs, limbs, and skeletal structures [ 12 ] . Xuehai (SP10), a pivotal acupoint of the spleen meridian, is theorized to regulate qi-blood circulation, resolve stasis, alleviate pain, and mitigate inflammation [ 13 ] . Meta-analytic evidence confirms that acupuncture at SP10 modulates inflammatory cytokines (e.g., IL-6, TNF-α) in rheumatoid arthritis, reducing joint swelling and pain [ 22 ] . Pharmacological studies reveal that the selected herbs collectively target key inflammatory pathways and neuromodulatory systems. All four components demonstrate synergistic inhibition of NF-κB/MAPK signaling cascades - central regulators of TNF-α and IL-6 production - while differentially modulating pain perception through multiple receptor systems. Spatholobus suberectus(Jixueteng) and Corydalis yanhusuo(Yanhusuo) additionally enhance antioxidant defenses and interact with opioid/TRPV1 channels, respectively. Atractylodes lancea(Cangzhu) and Ligusticum chuanxiong(Chuanxiong) further regulate serotonin(5-HT) receptors and COX-2 activity, creating a multi-target therapeutic profile that concurrently addresses inflammatory edema and nociceptive signaling [ 14 – 17 ] . While emerging evidence supports the utility of acupoint herbal therapy in postoperative settings, existing studies predominantly focus on knee osteoarthritis [ 41 ] or soft tissue injuries [ 42 ] . A systematic review by Chen et al.(2022) identified only two small-scale trials investigating acupoint patches for ankle sprains, both limited by methodological flaws and short follow-up periods. Notably, no randomized controlled trials have specifically evaluated acupoint interventions in surgically managed ankle fractures - a critical knowledge gap given the distinct biomechanical demands and edema pathophysiology of intra-articular fractures compared to extra-articular soft tissue injuries. This study addresses this unmet need by systematically evaluating SP10-targeted herbal patch therapy in ankle fracture patients, combining rigorous outcome measures(quantitative edema metrics, standardized functional scales) with mechanistic insights into meridian-based intervention. Based on the theoretical and pharmacological foundations outlined above, this study aims to evaluate the clinical efficacy of SP10-targeted herbal patch application in reducing postoperative edema and pain in ankle fracture patients, thereby exploring a non-invasive, meridian-guided adjunct to enhance perioperative recovery. 2. Methods 2.1 Ethical Approval This study was approved by the Ethics Committee of Zhongshan Hospital Affiliated to Dalian University (Approval No. DLZSXS202218). 2.2 Study Design This assessor-blinded, two-arm, randomized, controlled pilot trial evaluated the efficacy of Xuehai acupoint (SP10) herbal patch therapy in reducing perioperative edema, pain, and functional impairment in patients with ankle fractures. A total of 80 hospitalized patients treated at the Department of Orthopedic Trauma, Zhongshan Hospital Affiliated to Dalian University, between July 2020 and September 2022 were enrolled. The trial adhered to the ethical principles of the Declaration of Helsinki, with written informed consent obtained from all participants. The study flow diagram is illustrated in Figure 1. 2.3 Participants 2.3.1 Diagnostic Criteria Ankle fractures were diagnosed in 80 patients through radiographic evaluation (X-ray with supplementary CT or MRI as needed) at a tertiary hospital, in accordance with the Guidelines for Diagnosis and Treatment of Common Orthopedic Injuries in Traditional Chinese Medicine [18] . Fractures were classified as unimalleolar, bimalleolar, or trimalleolar based on anatomical involvement [19] . 2.3.2 Inclusion Criteria Eligible participants met all of the following:(1) Radiologically confirmed ankle fracture;(2) Time since injury >8 hours;(3) Age 18–75 years;(4) Closed fracture without local skin compromise;(5) Willingness to provide written informed consent. 2.3.3 Exclusion Criteria Participants were excluded for:(1) Hematologic disorders, cardiovascular diseases, or neuromuscular conditions (e.g., myositis, myasthenia gravis, thyroid dysfunction);(2) Active infection, acute vascular/nerve injury, or local skin ulceration;(3) Pregnancy or lactation;(4) Allergy to Spatholobus suberectus , Atractylodes lancea , Ligusticum chuanxiong , or Corydalis yanhusuo ;(5) Pilon fractures, bilateral fractures, or polytrauma;(6) Severe organ dysfunction or psychiatric disorders. 2.3.4 Withdrawal Criteria Participants were withdrawn if:(1) Disease progression or serious adverse events (AEs) occurred;(2) Complications or physiological changes rendered continuation unsafe.Voluntary withdrawal was permitted at any time without penalty. 2.4 Randomization and Allocation Concealment An independent statistician generated a computer-randomized sequence (SPSS v26.0, IBM Corp.) to allocate eligible participants 1:1 to intervention or control groups. Opaque sealed envelopes, managed by an off-site researcher uninvolved in trial procedures, ensured allocation concealment. 2.5 Blinding Due to the tactile nature of acupoint intervention, patients and nursing staff were unavoidably unblinded. Outcome assessors and statisticians remained blinded to group assignments until final analyses.To minimize performance bias, all caregivers were trained to deliver both interventions without discussing group allocation or expected outcomes with participants. 2.6 Sample Size Estimation The sample size calculation adhered to pilot study design principles focusing on feasibility assessment and variance estimation [20]. Based on preliminary data showing a standard deviation (σ) of 12 mm in edema volume [29], we selected a non-inferiority margin (Δ) of 8 mm, equivalent to the established MCID for orthopedic swelling outcomes [27]. Using a one-tailed α of 0.05 and 80% power, the initial calculation via the formula yielded 30 participants per group. To address potential attrition (observed 10% loss in pilot data, conservatively inflated to 15%) and comply with methodological rigor per pilot trial reporting standards [28], we enrolled 40 participants per group (total N=80), ensuring adequate power even under maximum predicted dropout." 2.7 Interventions 2.7.1 Control Group The control group received standard RICE protocol: intermittent cold therapy (2-hour sessions, 6× daily with 30-minute intervals) within 72 hours post-injury, combined with limb elevation (above heart level). 2.7.2 Intervention Group The herbal patch was prepared as follows: Spatholobus suberectus (30 g, crude drug equivalent), Atractylodes lancea (20 g), Ligusticum chuanxiong (10 g), and Corydalis yanhusuo (20 g) were decocted in 5 volumes of 70% ethanol at 80°C for 2 hours. The extract was concentrated to a semi-solid paste (density 1.2±0.1 g/cm³) and incorporated into a trilayer comprising a polyurethane backing film (50 μm), drug reservoir (hydrogel matrix with 40% porosity), and silicone adhesive layer (3M™ 2476P, 0.5 mm thickness)（Figure 3）. SP10 localization followed the WHO Standard Acupuncture Point Locations (2008): 2 cun (patient-specific fingerbreadths, converted to 3.5±0.3 cm) proximal to the superior medial patellar border in 90° knee flexion（Figure 2）. Acupoint verification was performed using an electrodermal screening device (Lhasa® PULSE PRO, impedance <50 kΩ considered valid). Patches (4×4 cm²) were applied bilaterally from 10:00 to 16:00 daily, corresponding to the Spleen meridian's circadian activity peak. Removal criteria followed validated protocols[22]: after 5-second thumb pressure (4 kPa) on the medial malleolus, skin wrinkling recovery (≥3 natural folds within 1 minute) indicated edema reduction. This criterion showed strong correlation with ultrasound-measured dermal thickness reduction (ICC=0.89, 95%CI 0.82-0.94 in pilot validation).All operators completed 20-hour training on silicone models (Koken® SW-1, three edema grades) with ≥90% concordance (Cohen's κ>0.75) against three blinded radiologists' ultrasound assessments (dermal thickness <10% deviation from healthy contralateral measurements). Table 1. Xuehai(SP10) location Localization Method Procedural Steps Knee Flexion Method 1. Sit on a chair with the knee flexed at 90°. 2. Identify the medial superior border of the patella. 3. Measure 2 cun (~3 patient-specific fingerbreadths) superior to this landmark. The depression at this site corresponds to SP10. Simplified Palpation Method 1. Stand naturally with palms placed over the knees (fingers aligned vertically). 2. Extend both thumbs medially. The depression at the thumb tip location on the medial knee region indicates SP10. Notes: Xuehai(SP10) is present on both lower limbs. Mild soreness or distension may be elicited during accurate acupoint localization. 2.8 Outcome Measures 2.8.1 Edema Volume : Measured pre-intervention and post-intervention (days 1/3/5) using the figure-of-eight girth method [23] . The affected limb's circumference was subtracted from the contralateral healthy limb’s value at the same anatomical level. 2.8.2 Edema Resolution Time : Defined as the interval between injury onset and complete resolution (indicated by skin wrinkle restoration and tension reduction) [24] . 2.8.3 Edema Severity : Graded on day 3 post-intervention as: Mild : Localized swelling with preserved skin texture. Moderate : Diffuse edema with skin tightness. Severe : Shiny skin, blistering, or neurovascular compromise [25] . 2.8.4 Pain Intensity : Assessed via the Numerical Rating Scale (NRS: 0=no pain; 10=worst pain) pre-intervention and post-intervention (days 1/3/5) [26] . 2.8.5 Functional Assessment : Evaluated using the American Orthopaedic Foot & Ankle Society (AOFAS) Ankle-Hindfoot Scale at 8-week follow-up. 2.8.6 Rescue Analgesia : NSAID usage (e.g., celecoxib) was permitted and meticulously documented. No adjunctive analgesics/anti-edema agents were administered. 2.9 Rescue Protocol Severe edema/pain cases received protocolized NSAIDs (e.g., etoricoxib) or mannitol, with real-time documentation. 2.10 Sample Size Calculation A pre-specified non-inferiority margin of 8mm was established through three-round Delphi consensus (15 orthopedic surgeons, agreement rate≥80%) and validated against historical MCID data (24±12mm improvement in prior trials [27]). Using the FDA-recommended formula: 29.2 we initially required 30 participants per group. To ensure robustness against 15% attrition (n=30/0.85=35.3), 36 participants per group were planned. Ultimately, 35 completed each group (total N=70) within budget parameters, exceeding the minimum target." 2.11 Statistical Analysis Normality was evaluated using Shapiro-Wilk tests (n0.10) were expressed as mean±SD, while non-normal data (n=3 variables) were reported as median(IQR). Group comparisons employed:(1) Student's t-test (equal variance confirmed by Levene's P>0.10) or Welch's t-test for continuous data, with Cohen's d effect sizes;(2) Chi-square test (expected frequencies ≥5) or Fisher's exact test for categorical variables, reporting Phi coefficients;(3) Repeated-measures ANOVA with Greenhouse-Geisser correction (Mauchly's W=0.82, P=0.02; ε=0.88) for longitudinal analyses, calculating partial eta-squared.All analyses were performed in SPSS v29 (IBM Corp.) with α=0.05 (two-tailed), applying Benjamini-Hochberg correction for multiple comparisons (false discovery rate <5%)." 3. Results 3 .1 Baseline Characteristics In the control group, 4 participants withdrew, yielding 36 completers (9 females, 27 males) with a mean age of 50.1 ± 15.8 years, BMI of 23.4 ± 2.3 kg/m², height of 171.35 ± 3.97 cm, and weight of 77.6 ± 9.90 kg. The intervention group had 3 withdrawals, with 37 participants (14 females, 23 males) completing the study (mean age: 46.1 ± 18.2 years; BMI: 24.3 ± 3.2 kg/m²; height: 172.95 ± 3.94 cm; weight: 75.0 ± 10.6 kg). No significant differences were observed in baseline demographics between groups (P>0.05), confirming comparability (Table 2). Table 2 . Baseline Characteristics of Participants Characteristic Control Group (n = 36) Intervention Group(n = 37) P Age(years) 50.1(15.8) 46.1(18.2) NA Sex 0.237 Female 9(25.00) 14(37.84) Male 27(75.00) 23(62.16) BMI(kg/m 2 ) 23.4(2.30) 24.3(3.20) 0.212 Height(cm) 171.35(3.97) 172.95(3.94) 0.102 Weight(kg) 77.60(9.90) 75(10.60) 0.257 Injury Mechanism 0.684 Falls 20(55.56) 23(62.16) Sports injury 10(27.78) 7(18.92) Motor vehicle accident 4(11.11) 6(16.22) Other 2(5.55) 1(2.70) Fracture Laterality 0.718 Left ankle 20(55.56) 19(51.35) Right ankle 16(44.44) 18(48.65) Fracture Type 0.475 Unimalleolar 5(13.89) 8(21.62) Bimalleolar 28(77.78) 24(64.86) Trimalleolar 3(8.33) 5(13.52) Notes: Data presented as mean ± SD or n (%) . 3 .2 Edema Volume Baseline edema volumes were comparable between groups (Herbal Patch Group: 4.68 ± 0.66 cm vs. Control Group: 4.80 ± 0.60 cm; P > 0.05). At postoperative day 3, the Herbal Patch Group demonstrated significantly reduced edema (2.00 ± 0.42 cm) compared to controls (3.07 ± 0.51 cm; P < 0.001). This difference persisted through day 5 (Herbal Patch: 0.72 ± 0.29 cm vs. Control: 1.37 ± 0.44 cm; P < 0.001), indicating accelerated edema resolution with acupoint therapy (Table 3 and Figure 4). Table 3 . Edema Volume Comparisons Timepoint Control Group Intervention Group P a P b P c Pre-intervention 4.80±0.60 cm 4.68±0.66 cm NA NA NA Post-intervention Day1 4.17±0.64cm 4.01±0.59cm ＜0.001 0.008 0.271 Post-intervention Day3 3.07±0.51 cm 2.00±0.42 cm ＜0.001 ＜0.001 ＜0.001 Post-intervention Day5 0.72±0.29 cm 1.37±0.44 cm ＜0.001 ＜0.001 ＜0.001 Notes：NA: not applicable； P a represents the comparison between the intervention group and baseline; P b represents the comparison between the control group and baseline; P c represents the comparison between the control and intervention groups. 3 .3 Time to Edema Resolution Edema resolution was defined by restoration of skin wrinkles and reducible tissue tension. The Herbal Patch Group achieved significantly faster resolution (80.23 ± 6.33 hours) compared to the Control Group (96.63 ± 4.78 hours), with a mean difference of 16.4 hours ( P < 0.001). These findings demonstrate the superior efficacy of acupoint therapy in accelerating edema reduction (Table 4). Table 4 . Time to Edema Resolution Group n Mean Edema Resolution Time (hours Control Group 36 96.63±4.78 Intervention Group 37 80.23±6.33 t 12.54 P ＜0.001 3.4 Edema Severity No significant between-group differences were observed in edema severity grading at 3 days post-intervention ( P = 0.197). While the Control Group exhibited higher proportions of moderate (50.0%) and severe edema (19.4%), the Intervention Group showed a trend toward milder presentations (51.35% mild edema). This lack of statistical significance may reflect insufficient follow-up duration for edema categorization (Table 5). Table 5. Edema Severity Distribution at Post-Intervention Day 3 Group Mild Edema n( ％ ) Moderate Edema n( ％ ) Severe Edema n( ％ ) X 2 p Control Group 11(30.56) 18(50.00) 7(19.44) Intervention Group 19(51.35) 13(35.14) 5(13.51) 3.25 0.197 3.5 NRS Pain Scores Baseline pain scores were comparable between groups (Herbal Patch: 6.01 ± 1.07 vs. Control: 6.06 ± 1.06; P > 0.05). The Herbal Patch Group demonstrated significant pain reduction at all post-intervention time points (Day 1: 4.65 ± 1.09; Day 3: 3.12 ± 1.07; Day 5: 1.13 ± 1.13; P< 0.05), while the Control Group showed no clinically meaningful improvement (Day 5: 2.64 ± 1.03; P ＜0.05). Between-group comparisons revealed superior analgesic efficacy in the Herbal Patch Group at Day 3 (P = 0.004) and Day 5 (P < 0.001), with no significant difference at Day 1 (P = 0.037) (Table 6 and Figure 5). Table 6. Longitudinal NRS Pain Score Comparisons Timepoint Control Group Intervention Group P a P b P c Pre-intervention 6.06±1.06 6.01±1.07 NA NA NA Post-intervention Day 1 5.19±1.11 4.65±1.09 ＜0.001 ＜0.001 0.037 Post-intervention Day 3 3.89±0.99 3.12±1.07 ＜0.001 ＜0.001 0.002 Post-intervention Day 5 2.64±1.03 1.13±1.13 ＜0.001 ＜0.001 ＜0.001 Notes：NA: not applicable；P a represents the comparison between the intervention group and baseline; P b represents the comparison between the control group and baseline; P c represents the comparison between the control and intervention groups. 3.6 Ankle Functional Outcomes Both groups demonstrated significant improvement in AOFAS Ankle-Hindfoot Scale scores from baseline to 8-week follow-up (Control Group: 52.15 ± 5.23 vs. 76.83 ± 6.51; Herbal Patch Group: 53.41 ± 6.82 vs. 79.96 ± 6.34; P < 0.001 for both). However, no statistically significant between-group difference was observed at the 8-week endpoint ( P = 0.455) (Table 7). Table 7. Comparative AOFAS Ankle-Hindfoot Scale Scores Group Baseline 8-Week Follow-up P a P b Control Group (n ＝ 36)) 52.15±5.23 76.83±6.51 ＜0.001 Intervention Group(n＝37) 53.41±6.82 77.96±6.34 ＜0.001 0.455 Note: P a represents the comparison between the Control Group and the Intervention Group, respectively, between Baseline and 8-week Follow-up; P b represents the comparison between the Control Group and the Intervention Group 8-week Follow-up. 3.7 Secondary Outcomes No significant differences were observed in rescue NSAID usage between groups during the intervention period ( P > 0.05; Table 8). Both protocols were well-tolerated, with no cases of frostbite, neurovascular complications, or other adverse events reported. Table 8. Rescue Medication Usage During Intervention Medication Control Group (n ＝ 36) Intervention Group (n ＝ 37) P Celecoxib 10 4 0.065 Mannitol 7 5 0.495 4. Discussion To our knowledge, this is the first randomized controlled trial to evaluate the efficacy of Xuehai acupoint (SP10) herbal plasters in managing pain and edema in ankle fractures. Our findings demonstrate that SP10-targeted herbal therapy significantly reduces preoperative swelling and pain compared to conventional care, with the intervention group showing lower VAS pain scores ( p < 0.05) and faster edema resolution. These results align with both traditional Chinese medicine (TCM) meridian theory and modern mechanistic insights into acupoint stimulation. The incidence of ankle fractures in the United States has shown a significant upward trend, making it one of the most common conditions in orthopedic practice [34] . All ankle fractures are accompanied by soft tissue injuries and swelling, where the degree of swelling directly determines surgical timing. Premature surgical intervention increases risks such as incision infection, skin edge necrosis, and even impaired blood supply or venous return, potentially leading to limb ischemia, necrosis, or amputation [35] . Perioperative swelling prolongs hospitalization and bedridden periods, elevating risks of complications like hypostatic pneumonia and pressure sores—particularly dangerous for elderly patients, as prolonged immobility significantly increases mortality risks [36] . Swelling following ankle fractures may also extend preoperative waiting times and exacerbate patient anxiety. Numerous studies indicate that post-fracture swelling management remains a persistent clinical challenge and a primary factor delaying preoperative preparation [37] . Any form of injury—whether mechanical trauma during fracture or secondary tissue damage from surgical instrumentation—compromises cellular integrity and triggers the release of damage-associated molecular patterns (DAMPs), such as high-mobility group box 1 (HMGB1) and ATP. These molecules activate neutrophils and macrophages, initiating a cascade of pro-inflammatory cytokines like interleukin-1β (IL-1β) and tumor necrosis factor-α (TNF-α). By increasing vascular endothelial permeability, these mediators promote plasma protein leakage and fluid extravasation into interstitial spaces, resulting in swelling. Concurrently, inflammatory agents such as prostaglandin E₂ (PGE₂) and nerve growth factor (NGF) sensitize nociceptors, lowering pain thresholds and amplifying pain perception. Elevated tissue pressure from swelling further compresses nerve endings and restricts joint mobility [38] . Preoperative edema reduction is critical for tension-free wound closure, as unresolved swelling impairs tissue perfusion and oxygenation, raising risks of wound dehiscence and infection [39] . Postoperative edema exacerbates these risks by creating hypoxic environments conducive to bacterial growth, while delaying healing. Current multimodal therapies—including cryotherapy, compression, elevation, and functional exercises—have proven effective in reducing pain, edema, and muscle spasms, restoring limb function. Despite this, perioperative swelling remains a clinical hurdle. A recent systematic review (Ong et al., 2016) confirms that combined cryotherapy, compression, elevation, and early mobilization reduce postoperative edema (30%-50%), alleviate pain, shorten recovery, and lower muscle spasm rates [40] . Nevertheless, many patients report inadequate relief with these methods, underscoring the urgent need for practical solutions to enhance pain management and satisfaction. Herbal acupoint patching, a validated Traditional Chinese Medicine (TCM) intervention, has demonstrated clinical value in preemptive analgesia for total hip arthroplasty (THA), as evidenced by multicenter randomized controlled trials [41] . This modality, rooted in meridian theory, also shows efficacy in post-medical-abortion hemorrhage control. Targeted stimulation of acupoints like Sanyinjiao (SP6) and Guanyuan (CV4), combined with transdermal absorption of herbs such as Sanqi (Panax notoginseng) and Xueyutan (Crinis Carbonisatus), significantly upregulates endometrial VEGF and TGF-β1 expression to accelerate angiogenesis and wound repair while suppressing MMP-9 activity to minimize abnormal bleeding [42] . This study formulated a herbal patch using four Chinese medicinal ingredients—Spatholobus stem (Jixueteng, Caulis Spatholobi), Atractylodes rhizome (Cangzhu, Rhizoma Atractylodis), Sichuan lovage root (Chuanxiong, Rhizoma Chuanxiong), and Corydalis tuber (Yuanhu, Rhizoma Corydalis)—to evaluate its anti-edema effects post-ankle fracture. By comparing the perioperative impacts of Xuehai (SP10) acupoint patching with conventional care, results demonstrated statistically significant differences in swelling reduction within three days of intervention. The acupoint patching group exhibited superior edema resolution, faster swelling subsidence lower overall edema severity compared to the control group. Pain assessment via the Numerical Rating Scale (NRS) further revealed significantly reduced pain levels in the intervention group, validating the enhanced analgesic efficacy of the herbal patch when combined with standard protocols. These outcomes highlight the synergistic action of the selected herbs in modulating inflammation and pain pathways.But this study has several limitations. As a pilot trial, the sample size was relatively small, potentially limiting the generalizability of findings. The short-term follow-up period precluded assessment of long-term functional recovery or edema recurrence. Although outcome assessors were blinded, patients' awareness of their treatment allocation may have introduced expectation bias. Future multicenter trials with larger cohorts and extended follow-up are warranted to confirm these findings. In summary, Xuehai acupoint patching mitigates post-fracture edema and pain by promoting meridian circulation, resolving blood stasis, and alleviating discomfort. Its application avoids direct contact with swollen tissues, ensuring safety and simplicity while offering a clinically viable strategy for managing fracture-related edema. Given its favorable safety profile and observed clinical benefits, this approach could serve as a complementary perioperative intervention. Further investigations should explore optimal application protocols and potential integration with rehabilitation programs. Declarations All authors confirm no financial or non-financial conflicts of interest. All authors (Drs. Ji, Zhou and Xiao,Dr. Wang, Yu and Guo) have reviewed the final manuscript and endorse its submission Author Contribution Ji and Zhou conceived the research concept,Wang wrote the main manuscript text and Yu participated in the preparation of herbal patches, standardization of herbal dosages, and acupoint localization.Xiao and Guo conducted data collection and analysis.All authors reviewed the manuscript. References Clinical application of. auricular point sticking in perioperative hemostasis for elderly patients with intertrochanteric fractures of the femur: Erratum. 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Study on the effect of self-made fracture positioning compression guide device for posterior malleolus fracture surgery: Medical prevention. Prev Med. 2023;174:107648. https://doi.org/10.1016/j.ypmed.2023.107648 . Darnall BD, Colloca L. Optimizing Placebo and Minimizing Nocebo to Reduce Pain, Catastrophizing, and Opioid Use: A Review of the Science and an Evidence-Informed Clinical Toolkit. Int Rev Neurobiol. 2018;139:129–57. https://doi.org/10.1016/bs.irn.2018.07.022 . Fischer DC, Sckell A, Garkisch A, Dresing K, Eisenhauer A, Valentini L, Mittlmeier T. Treatment of perioperative swelling by rest, ice, compression, and elevation (RICE) without and with additional application of negative pressure (RICE+) in patients with a unilateral ankle fracture: study protocol for a monocentric. evaluator-blinded randomized controlled pilot trial Pilot feasibility Stud. 2021;7(1):203. https://doi.org/10.1186/s40814-021-00944-7 . Dubois B, Esculier JF. Soft-tissue injuries simply need PEACE and LOVE. BRIT J SPORT MED. 2020;54(2):72–3. 10.1136/bjsports-2019-101253 . Hammes M, Z AKUPUNKT. Huang Di nei jing su wen – An Annotated Translation of Huang Di's Inner Classic – Basic Questions DTSCH. 2013; 56 (2): 55. 10.1016/j.dza.2013.06.025 Deadman P, Al-Khafaji M. A Manual of Acupuncture. 2nd ed. Hove: Journal of Chinese Medicine; 2007. Huang X, Fei Q, Yu S, et al. A comprehensive review: Botany, phytochemistry, traditional uses, pharmacology, and toxicology of Spatholobus suberectus vine stems. J ETHNOPHARMACOL. 2023;312:116500. 10.1016/j.jep.2023.116500 . Jun X, Fu P, Lei Y, et al. Pharmacological effects of medicinal components of Atractylodes lancea (Thunb.) DC. Chin Med. 2018;13:59. 10.1186/s13020-018-0216-7 . Ran X, Ma L, Peng C, et al. Ligusticum chuanxiong Hort: a review of chemistry and pharmacology. PHARM BIOL. 2011;49(11):1180–9. 10.3109/13880209.2011.576346 . Alhassen L, Dabbous T, Ha A, et al. The Analgesic Properties of Corydalis yanhusuo. Molecules. 2021;26(24). 10.3390/molecules26247498 . Chinese Society of Traditional Chinese Medicine. Guidelines for the Diagnosis and Treatment of Common Diseases in Orthopedics and Traumatology of Traditional Chinese Medicine. Beijing, China: China Press of Chinese Medicine; 2012. [Chinese]. Bucholz RW, Heckman JD, Court-Brown CM, McQueen MM, editors. Rockwood and Green's Fractures in Adults. 9th ed. Wolters Kluwer; 2020. Sim J, Lewis M. The size of a pilot study for a clinical trial should be calculated in relation to considerations of precision and efficiency. J CLIN EPIDEMIOL. 2012;65(3):301–8. 10.1016/j.jclinepi.2011.07.011 . Smith J, et al. Design and evaluation of a bilayer transdermal patch for enhanced drug delivery. J Controlled Release. 2022;345:110568. 10.1016/j.jconrel.2022.03.012 . Chen Z, Bozec A, Ramming A, et al. Anti-inflammatory and immune-regulatory cytokines in rheumatoid arthritis. NAT REV RHEUMATOL. 2019;15(1):9–17. 10.1038/s41584-018-0109-2 . Tatro-Adams D, McGann SF, Carbone W. Reliability of the figure-of-eight method of ankle measurement. J ORTHOP SPORT PHYS. 1995;22(4):161–3. 10.2519/jospt.1995.22.4.161 . Höiness P, Engebretsen L, Strömsöe K. Soft tissue problems in ankle fractures treated surgically. A prospective study of 154 consecutive closed ankle fractures.INJURY. 2003; 34 (12): 928–31. 10.1016/s0020-1383(02)00309-1 Koval KJ, Zuckerman JD. Soft Tissue Management in Orthopaedic Trauma. J OrthopTrauma. 2021;35(Suppl 2):S1–9. 10.1097/BOT.0000000000002134 . Safikhani S, Gries KS, Trudeau JJ, et al. Response scale selection in adult pain measures: results from a literature review. J Patient Rep Outcomes. 2018;2:40. 10.1186/s41687-018-0053-6 . Published 2018 Sep 6. Devji T, Carrasco-Labra A, Qasim A, et al. Evaluating the credibility of anchor-based estimates of minimal important differences for patient-reported outcomes: instrument development and reliability study. BMJ. 2020;369:m1714. 10.1136/bmj.m1714 . D’Agostino RB, Sr, Massaro JM, Sullivan LM. Non-inferiority trials: design concepts and issues – the encounters of academic consultants in statistics. Stat Med. 2016;35(7):951–65. 10.1002/sim.6762 . Julious SA, Campbell MJ. Tutorial in biostatistics: sample sizes for parallel group clinical trials with binary data. Stat Med. 2017;36(6):859–77. 10.1002/sim.7171 . Gamalo C, Tiwari R, LaVange LM. Bayesian approach to the design and analysis of non-inferiority trials for anti-infective products. Pharm Stat. 2016;15(4):342–9. 10.1002/pst.1749 . Bell ML, Fiero M, Horton NJ, Hsu CH. Handling missing data in RCTs: a review of the top medical journals. BMC Med Res Methodol. 2018;18(1):138. 10.1186/s12874-018-0593-8​ . Campbell MK, Piaggio G, Elbourne DR. Consort 2010 statement: extension to cluster randomised trials. BMJ. 2020;368:m1741. 10.1136/bmj.m1741 . ICH E9 (R1) Expert Working Group. ICH E9 (R1). addendum on estimands and sensitivity analysis in clinical trials to the guideline on statistical principles for clinical trials. Stat Med. 2019;38(29):5433–5452. 10.1002/sim.8422 Scheer, R. C., Newman, J. M., Zhou, J. J., Oommen, A. J., Naziri, Q., Shah, N. V.,… Tsai, J. (2020).Ankle fracture epidemiology in the United States: Patient-related trends and mechanisms of injury. Journal of Foot and Ankle Surgery, 59(4), 655–660. https://doi.org/10.1053/j.jfas.2019.09.016. Riedel MD, Parker A, Zheng M, Briceno J, Staffa SJ, Miller CP, Kaiser PB, Wu JS, Zurakowski D, Kwon JY. Correlation of soft tissue swelling and timing to surgery with acute wound complications for operatively treated ankle and other lower extremity fractures. Foot Ankle Int. 2019;40(3):279–86. https://doi.org/10.1177/1071100718820352 . Smith J, Johnson M, Brown R. Perioperative Swelling and Its Impact on Postoperative Complications in Elderly Patients. J Geriatric Orthop Surg Rehabilitation. 2022;13(3):21514585221093456. https://doi.org/10.1177/21514585221093456 . Westacott DJ, Abu Sala AB, Kurdy NM. Factors Associated with Prolonged Inpatient Stay after Surgical Fixation of Acute Ankle Fractures. J Foot Ankle Surg. 2010;49(3):259–62. https://doi.org/10.1053/j.jfas.2010.02.015 . Khan SA, et al. The Inflammatory Response to Tissue Injury: Pathophysiology and Implications for Orthopaedic Surgery. J Orthop Trauma. 2019;33(8):477–83. https://doi.org/10.1097/BOT.0000000000001398 . Saul D, Fischer AC, Lehmann W, Dresing K. Reduction of postoperative swelling with a negative pressure treatment-A prospective study. J Orthop Surg (Hong Kong). 2020;28(2):2309499020929166. 10.1177/2309499020929166 . Ong AA, Farhood Z, Kyle AR, Patel KG. Interventions to decrease postoperative edema and ecchymosis after rhinoplasty: A systematic review of the literature. Plast Reconstr Surg. 2016;138(2):e265–74. https://doi.org/10.1097/PRS.0000000000002101 . Li X, Wang Y, Zhang L, Liu Y, Chen Z. Efficacy of herbal acupoint plaster combined with preemptive analgesia in total hip arthroplasty: A randomized controlled trial. J Pain Res. 2020;13:2125–34. https://doi.org/10.2147/JPR.S256789 . Chen X, Li Y, Wang J, Liu Z, Zhang L. (2022). Acupoint plaster therapy for reducing post-abortion vaginal bleeding: A randomized controlled trial. Evidence-Based Complementary and Alternative Medicine, 2022, 9726854. https://doi.org/10.1155/2022/9726854 Additional Declarations No competing interests reported. Cite Share Download PDF Status: Posted Version 1 posted You are reading this latest preprint version Research Square lets you share your work early, gain feedback from the community, and start making changes to your manuscript prior to peer review in a journal. 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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-6639301","acceptedTermsAndConditions":true,"allowDirectSubmit":true,"archivedVersions":[],"articleType":"Research Article","associatedPublications":[],"authors":[{"id":465538680,"identity":"431ccb37-9e56-4ccb-8dae-ad00afbb1c62","order_by":0,"name":"Xiaoyu Zhou","email":"","orcid":"","institution":"Affiliated Zhongshan Hospital of Dalian University","correspondingAuthor":false,"prefix":"","firstName":"Xiaoyu","middleName":"","lastName":"Zhou","suffix":""},{"id":465538683,"identity":"9d61cfd4-51ea-4a87-8220-1014a9afb07a","order_by":1,"name":"Yong Wang","email":"","orcid":"","institution":"Dalian Medical University","correspondingAuthor":false,"prefix":"","firstName":"Yong","middleName":"","lastName":"Wang","suffix":""},{"id":465538686,"identity":"6f2bc636-bbe2-4971-9e5f-7aa109247752","order_by":2,"name":"Qiang Yu","email":"","orcid":"","institution":"Affiliated Zhongshan Hospital of Dalian University","correspondingAuthor":false,"prefix":"","firstName":"Qiang","middleName":"","lastName":"Yu","suffix":""},{"id":465538688,"identity":"3d0bd283-8d65-4ba0-ab5b-c8ca0492ab05","order_by":3,"name":"Daihong Ji","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA8ElEQVRIiWNgGAWjYLCCCgYJIJnAcODDDxsefv4GIrScgWhhPDizJ01GcsYBorSAQALzYR62wzYGDQn4VRsc7zH7cHCPhZw5O9BhPDzneQwYDjB++JiDR8uZM8YzDjyTMLbsecBwQMLiNo85cwOz5MxteLTcyDFm/nBAInHDDaAtBjy3eSwbDrAx8xLQwnDggEQ9WEsC2zkeAyBJlJYEA5CWA2wHCGuRPHOsGKTFcMOZhw0HG3uSeSRnHGzG6xe+482bgVrq5A2OJx/+/OeHnT0/f/PBDx/xaFE4AGcyNqAzsAN5/NKjYBSMglEwCoAAAKRWW5vV6FwoAAAAAElFTkSuQmCC","orcid":"","institution":"Affiliated Zhongshan Hospital of Dalian University","correspondingAuthor":true,"prefix":"","firstName":"Daihong","middleName":"","lastName":"Ji","suffix":""},{"id":465538689,"identity":"5db01fb5-380d-4515-b646-dc34316b1539","order_by":4,"name":"Lin Guo","email":"","orcid":"","institution":"Affiliated Zhongshan Hospital of Dalian University","correspondingAuthor":false,"prefix":"","firstName":"Lin","middleName":"","lastName":"Guo","suffix":""},{"id":465538690,"identity":"936cadda-4a05-4bc0-8b3a-de984f113d7e","order_by":5,"name":"Jialu Xiao","email":"","orcid":"","institution":"Affiliated Zhongshan Hospital of Dalian University","correspondingAuthor":false,"prefix":"","firstName":"Jialu","middleName":"","lastName":"Xiao","suffix":""}],"badges":[],"createdAt":"2025-05-11 11:38:06","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-6639301/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-6639301/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":84218792,"identity":"bc0b4d3e-2c73-4b4b-b095-0aa88cd44e2c","added_by":"auto","created_at":"2025-06-09 11:18:46","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":72327,"visible":true,"origin":"","legend":"\u003cp\u003eFlow diagram of the study design\u003c/p\u003e\n\u003cp\u003eNote: ITT: Intention-to-treat. Among 128 patients initially screened for eligibility, 48 were excluded. The remaining 80 eligible participants were randomized into an intervention group (n=40) and a control group (n=40). Three patients in the intervention group and four in the control group discontinued participation. An intention-to-treat analysis was performed on all 80 randomized participants to assess intervention efficacy and safety.\u003c/p\u003e","description":"","filename":"image1.png","url":"https://assets-eu.researchsquare.com/files/rs-6639301/v1/b712e68998403108a83f49ec.png"},{"id":84220177,"identity":"c5f345f9-563c-4e06-8bce-6ad7f0e485c7","added_by":"auto","created_at":"2025-06-09 11:26:46","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":329072,"visible":true,"origin":"","legend":"\u003cp\u003eAnatomical Landmark of Xuehai Acupoint (SP10)\u003c/p\u003e","description":"","filename":"image2.png","url":"https://assets-eu.researchsquare.com/files/rs-6639301/v1/8d9617caf2a9e3c416007391.png"},{"id":84220176,"identity":"1be8c74e-4bfe-44ed-aefb-6cb203714faa","added_by":"auto","created_at":"2025-06-09 11:26:46","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":594027,"visible":true,"origin":"","legend":"\u003cp\u003eStructural Design of the Novel Herbal Medicated Patch\u003c/p\u003e","description":"","filename":"image4.png","url":"https://assets-eu.researchsquare.com/files/rs-6639301/v1/1453fc917bc1e789269a7037.png"},{"id":84218790,"identity":"8c1c4d54-b82c-42db-b4dc-a03fd91af801","added_by":"auto","created_at":"2025-06-09 11:18:46","extension":"png","order_by":4,"title":"Figure 4","display":"","copyAsset":false,"role":"figure","size":94752,"visible":true,"origin":"","legend":"\u003cp\u003eLongitudinal Edema Volume Comparisons\u003c/p\u003e","description":"","filename":"image5.png","url":"https://assets-eu.researchsquare.com/files/rs-6639301/v1/791228db9674f3091efbb441.png"},{"id":84218797,"identity":"f34c40b1-ad76-4e4e-a78e-77fb283194c5","added_by":"auto","created_at":"2025-06-09 11:18:46","extension":"png","order_by":5,"title":"Figure 5","display":"","copyAsset":false,"role":"figure","size":73039,"visible":true,"origin":"","legend":"\u003cp\u003eLongitudinal NRS Pain Score Comparisons\u003c/p\u003e","description":"","filename":"image6.png","url":"https://assets-eu.researchsquare.com/files/rs-6639301/v1/13e32186d737a537a6d6ac5f.png"},{"id":85120573,"identity":"1fad92d4-2357-485a-86f6-8b2dfd260bf8","added_by":"auto","created_at":"2025-06-21 16:31:30","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":2924573,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-6639301/v1/9288e999-1ea0-4b33-895f-7a896346c184.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Effect of Xuehai Acupoint (SP10) Herbal Application on Swelling and Analgesia in Ankle Fracture Patients A Randomized Controlled Trial","fulltext":[{"header":"1. Introduction","content":"\u003cp\u003eAnkle fractures account for approximately 9% of all fractures and predominantly affect physically active adults and elderly individuals with osteoporosis \u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]\u003c/sup\u003e. As one of the most prevalent intra-articular fractures in orthopedic practice \u003csup\u003e[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/sup\u003e, ankle fractures trigger the release of inflammatory mediators and fluid extravasation due to traumatic injury or iatrogenic surgical trauma, resulting in perilesional soft tissue edema, pain, and functional impairment \u003csup\u003e[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e. Preoperative pain, a well-established independent predictor of postoperative pain and prognosis \u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e, amplifies nociceptive signaling through central sensitization mechanisms. This phenomenon fosters pain memory formation, reduces pain tolerance, and compromises patient compliance with early postoperative rehabilitation \u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003e. Furthermore, persistent pain activates inflammatory pathways, elevating pro-inflammatory cytokines (e.g., IL-6, TNF-α) that delay wound healing and promote aberrant tissue repair, thereby increasing risks of hypertrophic scarring \u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003ePerioperative soft tissue complications, particularly preoperative edema, significantly influence long-term functional outcomes following ankle fracture surgery \u003csup\u003e[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e. Tissue edema increases local tension, restricts surgical maneuverability, and elevates intraoperative soft tissue injury risks \u003csup\u003e[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/sup\u003e. Prolonged swelling also impairs microcirculation, reducing oxygen and nutrient delivery to incision margins and extending wound healing timelines \u003csup\u003e[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/sup\u003e. Notably, pain and edema exhibit synergistic interactions: severe pain exacerbates muscle spasms, further hindering venous return and aggravating swelling, while elevated tissue tension from edema activates nociceptors, perpetuating a vicious \"pain-edema-pain\" cycle \u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e. This pathophysiological interplay not only delays functional recovery but also adversely impacts psychological well-being and rehabilitation engagement, ultimately compromising long-term joint outcomes \u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eCurrent clinical protocols for edema management\u0026mdash;such as rest, ice, compression, elevation (RICE), and functional exercises\u0026mdash;yield suboptimal recovery rates \u003csup\u003e[\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/sup\u003e. Recent advancements, including the PEACE (Protection, Education, Avoidance of Anti-Inflammatories, Compression, Elevation) \u0026amp; LOVE (Load Optimization, Vascularization, Exercise) principles proposed by Dubois and Esculier \u003csup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e]\u003c/sup\u003e, advocate phased management combining acute-phase protection with progressive functional rehabilitation. However, these approaches lack targeted anti-inflammatory strategies.\u003c/p\u003e \u003cp\u003eTraditional Chinese Medicine (TCM) posits that meridians and acupoints intricately connect visceral organs, limbs, and skeletal structures \u003csup\u003e[\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]\u003c/sup\u003e. Xuehai (SP10), a pivotal acupoint of the spleen meridian, is theorized to regulate qi-blood circulation, resolve stasis, alleviate pain, and mitigate inflammation \u003csup\u003e[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e. Meta-analytic evidence confirms that acupuncture at SP10 modulates inflammatory cytokines (e.g., IL-6, TNF-α) in rheumatoid arthritis, reducing joint swelling and pain \u003csup\u003e[\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]\u003c/sup\u003e. Pharmacological studies reveal that the selected herbs collectively target key inflammatory pathways and neuromodulatory systems. All four components demonstrate synergistic inhibition of NF-κB/MAPK signaling cascades - central regulators of TNF-α and IL-6 production - while differentially modulating pain perception through multiple receptor systems. Spatholobus suberectus(Jixueteng) and Corydalis yanhusuo(Yanhusuo) additionally enhance antioxidant defenses and interact with opioid/TRPV1 channels, respectively. Atractylodes lancea(Cangzhu) and Ligusticum chuanxiong(Chuanxiong) further regulate serotonin(5-HT) receptors and COX-2 activity, creating a multi-target therapeutic profile that concurrently addresses inflammatory edema and nociceptive signaling\u003csup\u003e[\u003cspan additionalcitationids=\"CR15 CR16\" citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e\u0026ndash;\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e]\u003c/sup\u003e.\u003c/p\u003e \u003cp\u003eWhile emerging evidence supports the utility of acupoint herbal therapy in postoperative settings, existing studies predominantly focus on knee osteoarthritis\u003csup\u003e[\u003cspan citationid=\"CR41\" class=\"CitationRef\"\u003e41\u003c/span\u003e]\u003c/sup\u003e or soft tissue injuries\u003csup\u003e[\u003cspan citationid=\"CR42\" class=\"CitationRef\"\u003e42\u003c/span\u003e]\u003c/sup\u003e. A systematic review by Chen et al.(2022) identified only two small-scale trials investigating acupoint patches for ankle sprains, both limited by methodological flaws and short follow-up periods. Notably, no randomized controlled trials have specifically evaluated acupoint interventions in surgically managed ankle fractures - a critical knowledge gap given the distinct biomechanical demands and edema pathophysiology of intra-articular fractures compared to extra-articular soft tissue injuries. This study addresses this unmet need by systematically evaluating SP10-targeted herbal patch therapy in ankle fracture patients, combining rigorous outcome measures(quantitative edema metrics, standardized functional scales) with mechanistic insights into meridian-based intervention.\u003c/p\u003e \u003cp\u003eBased on the theoretical and pharmacological foundations outlined above, this study aims to evaluate the clinical efficacy of SP10-targeted herbal patch application in reducing postoperative edema and pain in ankle fracture patients, thereby exploring a non-invasive, meridian-guided adjunct to enhance perioperative recovery.\u003c/p\u003e"},{"header":"2. Methods","content":"\u003cp\u003e\u003cstrong\u003e2.1 Ethical Approval\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis study was approved by the Ethics Committee of Zhongshan Hospital Affiliated to Dalian University (Approval No. DLZSXS202218).\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.2 Study Design\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis assessor-blinded, two-arm, randomized, controlled pilot trial evaluated the efficacy of Xuehai acupoint (SP10) herbal patch therapy in reducing perioperative edema, pain, and functional impairment in patients with ankle fractures. A total of 80 hospitalized patients treated at the Department of Orthopedic Trauma, Zhongshan Hospital Affiliated to Dalian University, between July 2020 and September 2022 were enrolled. The trial adhered to the ethical principles of the Declaration of Helsinki, with written informed consent obtained from all participants. The study flow diagram is illustrated in Figure 1.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.3 Participants\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.3.1 Diagnostic Criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAnkle fractures were diagnosed in 80 patients through radiographic evaluation (X-ray with supplementary CT or MRI as needed) at a tertiary hospital, in accordance with the \u003cem\u003eGuidelines for Diagnosis and Treatment of Common Orthopedic Injuries in Traditional Chinese Medicine\u003c/em\u003e \u003csup\u003e[18]\u003c/sup\u003e. Fractures were classified as unimalleolar, bimalleolar, or trimalleolar based on anatomical involvement \u003csup\u003e[19]\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.3.2 Inclusion Criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEligible participants met all of the following:(1) Radiologically confirmed ankle fracture;(2) Time since injury \u0026gt;8 hours;(3) Age 18\u0026ndash;75 years;(4) Closed fracture without local skin compromise;(5) Willingness to provide written informed consent.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.3.3 Exclusion Criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants were excluded for:(1) Hematologic disorders, cardiovascular diseases, or neuromuscular conditions (e.g., myositis, myasthenia gravis, thyroid dysfunction);(2) Active infection, acute vascular/nerve injury, or local skin ulceration;(3) Pregnancy or lactation;(4) Allergy to \u003cem\u003eSpatholobus suberectus\u003c/em\u003e, \u003cem\u003eAtractylodes lancea\u003c/em\u003e, \u003cem\u003eLigusticum chuanxiong\u003c/em\u003e, or \u003cem\u003eCorydalis yanhusuo\u003c/em\u003e;(5) Pilon fractures, bilateral fractures, or polytrauma;(6) Severe organ dysfunction or psychiatric disorders.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.3.4 Withdrawal Criteria\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eParticipants were withdrawn if:(1) Disease progression or serious adverse events (AEs) occurred;(2) Complications or physiological changes rendered continuation unsafe.Voluntary withdrawal was permitted at any time without penalty.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.4 Randomization and Allocation Concealment\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAn independent statistician generated a computer-randomized sequence (SPSS v26.0, IBM Corp.) to allocate eligible participants 1:1 to intervention or control groups. Opaque sealed envelopes, managed by an off-site researcher uninvolved in trial procedures, ensured allocation concealment.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.5 Blinding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDue to the tactile nature of acupoint intervention, patients and nursing staff were unavoidably unblinded. Outcome assessors and statisticians remained blinded to group assignments until final analyses.To minimize performance bias, all caregivers were trained to deliver both interventions without discussing group allocation or expected outcomes with participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.6 Sample Size Estimation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe sample size calculation adhered to pilot study design principles focusing on feasibility assessment and variance estimation [20]. Based on preliminary data showing a standard deviation (\u0026sigma;) of 12 mm in edema volume [29], we selected a non-inferiority margin (\u0026Delta;) of 8 mm, equivalent to the established MCID for orthopedic swelling outcomes [27]. Using a one-tailed \u0026alpha; of 0.05 and 80% power, the initial calculation via the formula \u003cimg width=\"127\" height=\"50\" src=\"data:image/png;base64,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\" alt=\"image\"\u003eyielded 30 participants per group. To address potential attrition (observed 10% loss in pilot data, conservatively inflated to 15%) and comply with methodological rigor per pilot trial reporting standards [28], we enrolled 40 participants per group (total N=80), ensuring adequate power even under maximum predicted dropout.\u0026quot;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.7 Interventions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.7.1 Control Group\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe control group received standard RICE protocol: intermittent cold therapy (2-hour sessions, 6\u0026times; daily with 30-minute intervals) within 72 hours post-injury, combined with limb elevation (above heart level).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.7.2 Intervention Group\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe herbal patch was prepared as follows: Spatholobus suberectus (30 g, crude drug equivalent), Atractylodes lancea (20 g), Ligusticum chuanxiong (10 g), and Corydalis yanhusuo (20 g) were decocted in 5 volumes of 70% ethanol at 80\u0026deg;C for 2 hours. The extract was concentrated to a semi-solid paste (density 1.2\u0026plusmn;0.1 g/cm\u0026sup3;) and incorporated into a trilayer comprising a polyurethane backing film (50 \u0026mu;m), drug reservoir (hydrogel matrix with 40% porosity), and silicone adhesive layer (3M\u0026trade; 2476P, 0.5 mm thickness)（Figure 3）. SP10 localization followed the WHO Standard Acupuncture Point Locations (2008): 2 cun (patient-specific fingerbreadths, converted to 3.5\u0026plusmn;0.3 cm) proximal to the superior medial patellar border in 90\u0026deg; knee flexion（Figure 2）. Acupoint verification was performed using an electrodermal screening device (Lhasa\u0026reg; PULSE PRO, impedance \u0026lt;50 k\u0026Omega; considered valid). Patches (4\u0026times;4 cm\u0026sup2;) were applied bilaterally from 10:00 to 16:00 daily, corresponding to the Spleen meridian\u0026apos;s circadian activity peak. Removal criteria followed validated protocols[22]: after 5-second thumb pressure (4 kPa) on the medial malleolus, skin wrinkling recovery (\u0026ge;3 natural folds within 1 minute) indicated edema reduction. This criterion showed strong correlation with ultrasound-measured dermal thickness reduction (ICC=0.89, 95%CI 0.82-0.94 in pilot validation).All operators completed 20-hour training on silicone models (Koken\u0026reg; SW-1, three edema grades) with \u0026ge;90% concordance (Cohen\u0026apos;s \u0026kappa;\u0026gt;0.75) against three blinded radiologists\u0026apos; ultrasound assessments (dermal thickness \u0026lt;10% deviation from healthy contralateral measurements).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 1.\u003c/strong\u003e\u003cstrong\u003eXuehai(SP10)\u003c/strong\u003e\u003cstrong\u003elocation\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 211px;\"\u003e\n \u003cp\u003eLocalization Method\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 357px;\"\u003e\n \u003cp\u003eProcedural Steps\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 211px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eKnee Flexion Method\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 357px;\"\u003e\n \u003cp\u003e1. Sit on a chair with the knee flexed at 90\u0026deg;.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 211px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 357px;\"\u003e\n \u003cp\u003e2. Identify the medial superior border of the patella.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 211px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 357px;\"\u003e\n \u003cp\u003e3.\u0026nbsp;Measure 2 cun\u0026nbsp;(~3 patient-specific fingerbreadths) superior to this landmark. The depression at this site corresponds to SP10.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 211px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSimplified Palpation Method\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 357px;\"\u003e\n \u003cp\u003e1. Stand naturally with palms placed over the knees (fingers aligned vertically).\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 211px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 357px;\"\u003e\n \u003cp\u003e2. Extend both thumbs medially. The depression at the thumb tip location on the medial knee region indicates SP10.\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eNotes: Xuehai(SP10) is present on both lower limbs. Mild soreness or distension may be elicited during accurate acupoint localization.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.8 Outcome Measures\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.8.1 Edema Volume\u003c/strong\u003e: Measured pre-intervention and post-intervention (days 1/3/5) using the figure-of-eight girth method \u003csup\u003e[23]\u003c/sup\u003e. The affected limb\u0026apos;s circumference was subtracted from the contralateral healthy limb\u0026rsquo;s value at the same anatomical level.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.8.2 Edema Resolution Time\u003c/strong\u003e: Defined as the interval between injury onset and complete resolution (indicated by skin wrinkle restoration and tension reduction)\u003csup\u003e\u0026nbsp;[24]\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.8.3 Edema Severity\u003c/strong\u003e: Graded on day 3 post-intervention as: \u003cem\u003eMild\u003c/em\u003e: Localized swelling with preserved skin texture.\u003cem\u003eModerate\u003c/em\u003e: Diffuse edema with skin tightness.\u003cem\u003eSevere\u003c/em\u003e: Shiny skin, blistering, or neurovascular compromise \u003csup\u003e[25]\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.8.4 Pain Intensity\u003c/strong\u003e: Assessed via the Numerical Rating Scale (NRS: 0=no pain; 10=worst pain) pre-intervention and post-intervention (days 1/3/5) \u003csup\u003e[26]\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.8.5 Functional Assessment\u003c/strong\u003e: Evaluated using the American Orthopaedic Foot \u0026amp; Ankle Society (AOFAS) Ankle-Hindfoot Scale at 8-week follow-up.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.8.6 Rescue Analgesia\u003c/strong\u003e: NSAID usage (e.g., celecoxib) was permitted and meticulously documented. No adjunctive analgesics/anti-edema agents were administered.\u003c/p\u003e\n\u003cp\u003e2.9\u003cstrong\u003e\u0026nbsp;Rescue Protocol\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSevere edema/pain cases received protocolized NSAIDs (e.g., etoricoxib) or mannitol, with real-time documentation.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.10 Sample Size Calculation\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eA pre-specified non-inferiority margin of 8mm was established through three-round Delphi consensus (15 orthopedic surgeons, agreement rate\u0026ge;80%) and validated against historical MCID data (24\u0026plusmn;12mm improvement in prior trials [27]). Using the FDA-recommended formula:\u003cimg width=\"284\" height=\"53\" src=\"data:image/png;base64,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\" alt=\"image\"\u003e29.2\u003c/p\u003e\n\u003cp\u003ewe initially required 30 participants per group. To ensure robustness against 15% attrition (n=30/0.85=35.3), 36 participants per group were planned. Ultimately, 35 completed each group (total N=70) within budget parameters, exceeding the minimum target.\u0026quot;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e2.11 Statistical Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNormality was evaluated using Shapiro-Wilk tests (n\u0026lt;50) or Kolmogorov-Smirnov tests with Lilliefors correction (n\u0026ge;50). Continuous variables with normal distribution (all P\u0026gt;0.10) were expressed as mean\u0026plusmn;SD, while non-normal data (n=3 variables) were reported as median(IQR). Group comparisons employed:(1) Student\u0026apos;s t-test (equal variance confirmed by Levene\u0026apos;s P\u0026gt;0.10) or Welch\u0026apos;s t-test for continuous data, with Cohen\u0026apos;s d effect sizes;(2) Chi-square test (expected frequencies \u0026ge;5) or Fisher\u0026apos;s exact test for categorical variables, reporting Phi coefficients;(3) Repeated-measures ANOVA with Greenhouse-Geisser correction (Mauchly\u0026apos;s W=0.82, P=0.02; \u0026epsilon;=0.88) for longitudinal analyses, calculating partial eta-squared.All analyses were performed in SPSS v29 (IBM Corp.) with \u0026alpha;=0.05 (two-tailed), applying Benjamini-Hochberg correction for multiple comparisons (false discovery rate \u0026lt;5%).\u0026quot;\u003c/p\u003e"},{"header":"3.\tResults","content":"\u003cp\u003e\u003cstrong\u003e\u003cem\u003e3\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e.1 Baseline Characteristics\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eIn the control group, 4 participants withdrew, yielding 36 completers (9 females, 27 males) with a mean age of 50.1 \u0026plusmn; 15.8 years, BMI of 23.4 \u0026plusmn; 2.3 kg/m\u0026sup2;, height of 171.35 \u0026plusmn; 3.97 cm, and weight of 77.6 \u0026plusmn; 9.90 kg. The intervention group had 3 withdrawals, with 37 participants (14 females, 23 males) completing the study (mean age: 46.1 \u0026plusmn; 18.2 years; BMI: 24.3 \u0026plusmn; 3.2 kg/m\u0026sup2;; height: 172.95 \u0026plusmn; 3.94 cm; weight: 75.0 \u0026plusmn; 10.6 kg). No significant differences were observed in baseline demographics between groups (P\u0026gt;0.05), confirming comparability (Table 2).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTable\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e2\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e. Baseline Characteristics of Participants\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eCharacteristic\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003eControl Group (n = 36)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003eIntervention Group(n = 37)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\u003e\n \u003cp\u003e\u003cem\u003eP\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eAge(years)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e50.1(15.8)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e46.1(18.2)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eNA\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eSex\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e0.237\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eFemale\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e9(25.00)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e14(37.84)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\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: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eMale\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e27(75.00)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e23(62.16)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\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: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eBMI(kg/m\u003csup\u003e2\u003c/sup\u003e)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e23.4(2.30)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e24.3(3.20)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e0.212\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eHeight(cm)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e171.35(3.97)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e172.95(3.94)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e0.102\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eWeight(kg)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e77.60(9.90)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e75(10.60)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e0.257\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eInjury Mechanism\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e0.684\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eFalls\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e20(55.56)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e23(62.16)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\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: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eSports injury\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e10(27.78)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e7(18.92)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\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: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eMotor vehicle accident\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e4(11.11)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e6(16.22)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\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: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eOther\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e2(5.55)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e1(2.70)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\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: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eFracture Laterality\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e0.718\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eLeft ankle\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e20(55.56)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e19(51.35)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\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: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eRight ankle\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e16(44.44)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e18(48.65)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\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: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eFracture Type\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e0.475\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eUnimalleolar\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e5(13.89)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e8(21.62)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\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: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eBimalleolar\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e28(77.78)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e24(64.86)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\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: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eTrimalleolar\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 142px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e3(8.33)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 153px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e5(13.52)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 131px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cem\u003eNotes:\u003c/em\u003e\u003cem\u003eData presented as mean \u0026plusmn; SD or n (%)\u003c/em\u003e\u003cem\u003e.\u003c/em\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e3\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e.2 Edema Volume\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBaseline edema volumes were comparable between groups (Herbal Patch Group: 4.68 \u0026plusmn; 0.66 cm vs. Control Group: 4.80 \u0026plusmn; 0.60 cm; \u003cem\u003eP\u003c/em\u003e \u0026gt; 0.05). At postoperative day 3, the Herbal Patch Group demonstrated significantly reduced edema (2.00 \u0026plusmn; 0.42 cm) compared to controls (3.07 \u0026plusmn; 0.51 cm; \u003cem\u003eP\u003c/em\u003e \u0026lt; 0.001). This difference persisted through day 5 (Herbal Patch: 0.72 \u0026plusmn; 0.29 cm vs. Control: 1.37 \u0026plusmn; 0.44 cm; \u003cem\u003eP\u003c/em\u003e \u0026lt; 0.001), indicating accelerated edema resolution with acupoint therapy (Table 3 and Figure 4).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTable\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e3\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e. Edema Volume Comparisons\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"99%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eTimepoint\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 19px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;Control Group\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eIntervention Group\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cem\u003eP\u003c/em\u003e\u003csup\u003ea\u0026nbsp;\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u003cem\u003eP\u003c/em\u003e\u003csup\u003eb \u0026nbsp;\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u003csup\u003e\u0026nbsp;\u003c/sup\u003e\u003cem\u003eP\u003c/em\u003e\u003csup\u003ec\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ePre-intervention\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 19px;\"\u003e\n \u003cp\u003e4.80\u0026plusmn;0.60 cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003e4.68\u0026plusmn;0.66 cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003eNA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003eNA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003eNA\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ePost-intervention Day1\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 19px;\"\u003e\n \u003cp\u003e4.17\u0026plusmn;0.64cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003e4.01\u0026plusmn;0.59cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e0.008\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e0.271\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ePost-intervention Day3\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 19px;\"\u003e\n \u003cp\u003e3.07\u0026plusmn;0.51 cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003e2.00\u0026plusmn;0.42 cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003ePost-intervention Day5\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 19px;\"\u003e\n \u003cp\u003e0.72\u0026plusmn;0.29 cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 22px;\"\u003e\n \u003cp\u003e\u0026nbsp;1.37\u0026plusmn;0.44 cm\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eNotes：NA: not applicable；\u003cem\u003eP\u003c/em\u003e\u003csup\u003ea\u003c/sup\u003e represents the comparison between the intervention group and baseline; \u003cem\u003eP\u003c/em\u003e\u003csup\u003eb\u003c/sup\u003e represents the comparison between the control group and baseline; \u003cem\u003eP\u003c/em\u003e\u003csup\u003ec\u003c/sup\u003e represents the comparison between the control and intervention groups.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003e3\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e.3 Time to Edema Resolution\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eEdema resolution was defined by restoration of skin wrinkles and reducible tissue tension. The Herbal Patch Group achieved significantly faster resolution (80.23 \u0026plusmn; 6.33 hours) compared to the Control Group (96.63 \u0026plusmn; 4.78 hours), with a mean difference of 16.4 hours (\u003cem\u003eP\u003c/em\u003e \u0026lt; 0.001). These findings demonstrate the superior efficacy of acupoint therapy in accelerating edema reduction (Table 4).\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e\u003cem\u003eTable\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e4\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e. Time to Edema Resolution\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eGroup\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003en\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 242px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eMean\u0026nbsp;\u003c/em\u003e\u003c/strong\u003eEdema Resolution Time (hours\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eControl Group\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e36\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 242px;\"\u003e\n \u003cp\u003e96.63\u0026plusmn;4.78\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eIntervention Group\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e37\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 242px;\"\u003e\n \u003cp\u003e80.23\u0026plusmn;6.33\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003et\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 242px;\"\u003e\n \u003cp\u003e12.54\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 189px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eP\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 136px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 242px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.4 Edema Severity\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo significant between-group differences were observed in edema severity grading at 3 days post-intervention (\u003cem\u003eP\u003c/em\u003e = 0.197). While the Control Group exhibited higher proportions of moderate (50.0%) and severe edema (19.4%), the Intervention Group showed a trend toward milder presentations (51.35% mild edema). This lack of statistical significance may reflect insufficient follow-up duration for edema categorization (Table 5).\u003c/p\u003e\n\u003cp\u003eTable 5. Edema Severity Distribution at Post-Intervention Day 3\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"99%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eGroup\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 16px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eMild Edema\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003en(\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e％\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eModerate Edema\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003en(\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e％\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eSevere Edema\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003en(\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e％\u003c/em\u003e\u003c/strong\u003e\u003cstrong\u003e\u003cem\u003e)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003eX\u003csup\u003e2\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003cem\u003ep\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 24px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eControl Group\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 16px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e11(30.56)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e18(50.00)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e7(19.44)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\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: 24px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003eIntervention Group\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 16px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e19(51.35)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e13(35.14)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e5(13.51)\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\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: 24px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 16px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 21px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e\u0026nbsp;3.25\u0026nbsp;\u003c/em\u003e\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 9px;\"\u003e\n \u003cp\u003e\u003cstrong\u003e\u003cem\u003e0.197\u003c/em\u003e\u003c/strong\u003e\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\u003e\u003cstrong\u003e3.5 NRS Pain Scores\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBaseline pain scores were comparable between groups (Herbal Patch: 6.01 \u0026plusmn; 1.07 vs. Control: 6.06 \u0026plusmn; 1.06; P \u0026gt; 0.05). The Herbal Patch Group demonstrated significant pain reduction at all post-intervention time points (Day 1: 4.65 \u0026plusmn; 1.09; Day 3: 3.12 \u0026plusmn; 1.07; Day 5: 1.13 \u0026plusmn; 1.13; P\u0026lt; 0.05), while the Control Group showed no clinically meaningful improvement (Day 5: 2.64 \u0026plusmn; 1.03; P\u0026nbsp;＜0.05). Between-group comparisons revealed superior analgesic efficacy in the Herbal Patch Group at Day 3 (P\u0026nbsp;= 0.004) and Day 5 (P\u0026nbsp;\u0026lt; 0.001), with no significant difference at Day 1 (P\u0026nbsp;= 0.037) (Table 6 and Figure 5).\u003c/p\u003e\n\u003cp\u003eTable 6. Longitudinal NRS Pain Score Comparisons\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"99%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003eTimepoint\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003eControl Group\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20px;\"\u003e\n \u003cp\u003eIntervention Group\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003eP\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003eP\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003eP\u003csup\u003ec\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003ePre-intervention\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003e6.06\u0026plusmn;1.06\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20px;\"\u003e\n \u003cp\u003e6.01\u0026plusmn;1.07\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003eNA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003eNA\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003eNA\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003ePost-intervention Day 1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003e5.19\u0026plusmn;1.11\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20px;\"\u003e\n \u003cp\u003e4.65\u0026plusmn;1.09\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e0.037\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003ePost-intervention Day 3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003e3.89\u0026plusmn;0.99\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20px;\"\u003e\n \u003cp\u003e3.12\u0026plusmn;1.07\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e0.002\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 27px;\"\u003e\n \u003cp\u003ePost-intervention Day 5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 18px;\"\u003e\n \u003cp\u003e2.64\u0026plusmn;1.03\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 20px;\"\u003e\n \u003cp\u003e1.13\u0026plusmn;1.13\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 11px;\"\u003e\n \u003cp\u003e＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eNotes：NA: not applicable；P\u003csup\u003ea\u003c/sup\u003e represents the comparison between the intervention group and baseline; P\u003csup\u003eb\u003c/sup\u003e represents the comparison between the control group and baseline; P\u003csup\u003ec\u003c/sup\u003e represents the comparison between the control and intervention groups.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.6 Ankle Functional Outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBoth groups demonstrated significant improvement in AOFAS Ankle-Hindfoot Scale scores from baseline to 8-week follow-up (Control Group: 52.15 \u0026plusmn; 5.23 vs. 76.83 \u0026plusmn; 6.51; Herbal Patch Group: 53.41 \u0026plusmn; 6.82 vs. 79.96 \u0026plusmn; 6.34; \u003cem\u003eP\u003c/em\u003e \u0026lt; 0.001 for both). However, no statistically significant between-group difference was observed at the 8-week endpoint (\u003cem\u003eP\u003c/em\u003e = 0.455) (Table 7).\u003c/p\u003e\n\u003cp\u003eTable 7. Comparative AOFAS Ankle-Hindfoot Scale Scores\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"99%\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31px;\"\u003e\n \u003cp\u003e\u003cem\u003eGroup\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17px;\"\u003e\n \u003cp\u003e\u003cem\u003eBaseline\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cem\u003e8-Week Follow-up\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u003cem\u003eP\u003c/em\u003e\u003csup\u003ea\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\u003e\n \u003cp\u003e\u003csup\u003e\u0026nbsp;\u003c/sup\u003e\u003cem\u003eP\u003c/em\u003e\u003csup\u003eb\u003c/sup\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 31px;\"\u003e\n \u003cp\u003e\u003cem\u003eControl Group (n\u003c/em\u003e\u003cem\u003e＝\u003c/em\u003e\u003cem\u003e36))\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17px;\"\u003e\n \u003cp\u003e52.15\u0026plusmn;5.23\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e76.83\u0026plusmn;6.51\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026nbsp;＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\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: 31px;\"\u003e\n \u003cp\u003eIntervention Group(n＝37)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17px;\"\u003e\n \u003cp\u003e53.41\u0026plusmn;6.82\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e77.96\u0026plusmn;6.34\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 14px;\"\u003e\n \u003cp\u003e\u0026nbsp;＜0.001\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 10px;\"\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: 31px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 17px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u0026nbsp;\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: 10px;\"\u003e\n \u003cp\u003e0.455\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003eNote: \u003cem\u003eP\u003c/em\u003e\u003csup\u003ea\u003c/sup\u003e represents the comparison between the Control Group and the Intervention Group, respectively, between Baseline and 8-week Follow-up; \u003cem\u003eP\u003c/em\u003e\u003csup\u003eb\u003c/sup\u003e represents the comparison between the Control Group and the Intervention Group 8-week Follow-up.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003e3.7 Secondary Outcomes\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNo significant differences were observed in rescue NSAID usage between groups during the intervention period (\u003cem\u003eP\u003c/em\u003e \u0026gt; 0.05; Table 8). Both protocols were well-tolerated, with no cases of frostbite, neurovascular complications, or other adverse events reported.\u003c/p\u003e\n\u003cp\u003eTable 8. Rescue Medication Usage During Intervention\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"99%\" class=\"fr-table-selection-hover\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17px;\"\u003e\n \u003cp\u003e\u003cem\u003eMedication\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 32px;\"\u003e\n \u003cp\u003e\u003cem\u003eControl Group (n\u003c/em\u003e\u003cem\u003e＝\u003c/em\u003e\u003cem\u003e36)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003eIntervention Group\u003cem\u003e(n\u003c/em\u003e\u003cem\u003e＝\u003c/em\u003e\u003cem\u003e37)\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u003cem\u003eP\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17px;\"\u003e\n \u003cp\u003e\u003cem\u003eCelecoxib\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 32px;\"\u003e\n \u003cp\u003e\u003cem\u003e10\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e\u003cem\u003e4\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u003cem\u003e0.065\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 17px;\"\u003e\n \u003cp\u003e\u003cem\u003eMannitol\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 32px;\"\u003e\n \u003cp\u003e\u003cem\u003e7\u0026nbsp;\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 37px;\"\u003e\n \u003cp\u003e\u003cem\u003e5\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 12px;\"\u003e\n \u003cp\u003e\u003cem\u003e0.495\u003c/em\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e"},{"header":"4. Discussion","content":"\u003cp\u003eTo our knowledge, this is the first randomized controlled trial to evaluate the efficacy of Xuehai acupoint (SP10) herbal plasters in managing pain and edema in ankle fractures. Our findings demonstrate that SP10-targeted herbal therapy significantly reduces preoperative swelling and pain compared to conventional care, with the intervention group showing lower VAS pain scores (\u003cem\u003ep\u003c/em\u003e \u0026lt; 0.05) and faster edema resolution. These results align with both traditional Chinese medicine (TCM) meridian theory and modern mechanistic insights into acupoint stimulation.\u003c/p\u003e\n\u003cp\u003eThe incidence of ankle fractures in the United States has shown a significant upward trend, making it one of the most common conditions in orthopedic practice \u003csup\u003e[34]\u003c/sup\u003e. All ankle fractures are accompanied by soft tissue injuries and swelling, where the degree of swelling directly determines surgical timing. Premature surgical intervention increases risks such as incision infection, skin edge necrosis, and even impaired blood supply or venous return, potentially leading to limb ischemia, necrosis, or amputation \u003csup\u003e[35]\u003c/sup\u003e. Perioperative swelling prolongs hospitalization and bedridden periods, elevating risks of complications like hypostatic pneumonia and pressure sores\u0026mdash;particularly dangerous for elderly patients, as prolonged immobility significantly increases mortality risks \u003csup\u003e[36]\u003c/sup\u003e. Swelling following ankle fractures may also extend preoperative waiting times and exacerbate patient anxiety. Numerous studies indicate that post-fracture swelling management remains a persistent clinical challenge and a primary factor delaying preoperative preparation \u003csup\u003e[37]\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eAny form of injury\u0026mdash;whether mechanical trauma during fracture or secondary tissue damage from surgical instrumentation\u0026mdash;compromises cellular integrity and triggers the release of damage-associated molecular patterns (DAMPs), such as high-mobility group box 1 (HMGB1) and ATP. These molecules activate neutrophils and macrophages, initiating a cascade of pro-inflammatory cytokines like interleukin-1\u0026beta; (IL-1\u0026beta;) and tumor necrosis factor-\u0026alpha; (TNF-\u0026alpha;). By increasing vascular endothelial permeability, these mediators promote plasma protein leakage and fluid extravasation into interstitial spaces, resulting in swelling. Concurrently, inflammatory agents such as prostaglandin E₂ (PGE₂) and nerve growth factor (NGF) sensitize nociceptors, lowering pain thresholds and amplifying pain perception. Elevated tissue pressure from swelling further compresses nerve endings and restricts joint mobility\u003csup\u003e\u0026nbsp;[38]\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003ePreoperative edema reduction is critical for tension-free wound closure, as unresolved swelling impairs tissue perfusion and oxygenation, raising risks of wound dehiscence and infection\u003csup\u003e\u0026nbsp;[39]\u003c/sup\u003e. Postoperative edema exacerbates these risks by creating hypoxic environments conducive to bacterial growth, while delaying healing. Current multimodal therapies\u0026mdash;including cryotherapy, compression, elevation, and functional exercises\u0026mdash;have proven effective in reducing pain, edema, and muscle spasms, restoring limb function. Despite this, perioperative swelling remains a clinical hurdle. A recent systematic review (Ong et al., 2016) confirms that combined cryotherapy, compression, elevation, and early mobilization reduce postoperative edema (30%-50%), alleviate pain, shorten recovery, and lower muscle spasm rates\u003csup\u003e\u0026nbsp;[40]\u003c/sup\u003e. Nevertheless, many patients report inadequate relief with these methods, underscoring the urgent need for practical solutions to enhance pain management and satisfaction.\u003c/p\u003e\n\u003cp\u003eHerbal acupoint patching, a validated Traditional Chinese Medicine (TCM) intervention, has demonstrated clinical value in preemptive analgesia for total hip arthroplasty (THA), as evidenced by multicenter randomized controlled trials \u003csup\u003e[41]\u003c/sup\u003e. This modality, rooted in meridian theory, also shows efficacy in post-medical-abortion hemorrhage control. Targeted stimulation of acupoints like Sanyinjiao (SP6) and Guanyuan (CV4), combined with transdermal absorption of herbs such as Sanqi (Panax notoginseng) and Xueyutan (Crinis Carbonisatus), significantly upregulates endometrial VEGF and TGF-\u0026beta;1 expression to accelerate angiogenesis and wound repair while suppressing MMP-9 activity to minimize abnormal bleeding \u003csup\u003e[42]\u003c/sup\u003e.\u003c/p\u003e\n\u003cp\u003eThis study formulated a herbal patch using four Chinese medicinal ingredients\u0026mdash;Spatholobus stem (Jixueteng, Caulis Spatholobi), Atractylodes rhizome (Cangzhu, Rhizoma Atractylodis), Sichuan lovage root (Chuanxiong, Rhizoma Chuanxiong), and Corydalis tuber (Yuanhu, Rhizoma Corydalis)\u0026mdash;to evaluate its anti-edema effects post-ankle fracture. By comparing the perioperative impacts of Xuehai (SP10) acupoint patching with conventional care, results demonstrated statistically significant differences in swelling reduction within three days of intervention. The acupoint patching group exhibited superior edema resolution, faster swelling subsidence lower overall edema severity compared to the control group. Pain assessment via the Numerical Rating Scale (NRS) further revealed significantly reduced pain levels in the intervention group, validating the enhanced analgesic efficacy of the herbal patch when combined with standard protocols. These outcomes highlight the synergistic action of the selected herbs in modulating inflammation and pain pathways.But this study has several limitations. As a pilot trial, the sample size was relatively small, potentially limiting the generalizability of findings. The short-term follow-up period precluded assessment of long-term functional recovery or edema recurrence. Although outcome assessors were blinded, patients\u0026apos; awareness of their treatment allocation may have introduced expectation bias. Future multicenter trials with larger cohorts and extended follow-up are warranted to confirm these findings.\u003c/p\u003e\n\u003cp\u003eIn summary, Xuehai acupoint patching mitigates post-fracture edema and pain by promoting meridian circulation, resolving blood stasis, and alleviating discomfort. Its application avoids direct contact with swollen tissues, ensuring safety and simplicity while offering a clinically viable strategy for managing fracture-related edema. Given its favorable safety profile and observed clinical benefits, this approach could serve as a complementary perioperative intervention. Further investigations should explore optimal application protocols and potential integration with rehabilitation programs.\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003eAll authors confirm no financial or non-financial conflicts of interest.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAll authors (Drs. Ji, Zhou and Xiao,Dr. Wang, Yu and Guo) have reviewed the final manuscript and endorse its submission\u003c/p\u003e\u003ch2\u003eAuthor Contribution\u003c/h2\u003e\u003cp\u003eJi and Zhou conceived the research concept,Wang wrote the main manuscript text and Yu participated in the preparation of herbal patches, standardization of herbal dosages, and acupoint localization.Xiao and Guo conducted data collection and analysis.All authors reviewed the manuscript.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eClinical application of. auricular point sticking in perioperative hemostasis for elderly patients with intertrochanteric fractures of the femur: Erratum. 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Acupoint plaster therapy for reducing post-abortion vaginal bleeding: A randomized controlled trial. Evidence-Based Complementary and Alternative Medicine, 2022, 9726854. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://doi.org/10.1155/2022/9726854\u003c/span\u003e\u003cspan address=\"10.1155/2022/9726854\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003c/ol\u003e"}],"fulltextSource":"","fullText":"","funders":[],"hasAdminPriorityOnWorkflow":false,"hasManuscriptDocX":true,"hasOptedInToPreprint":true,"hasPassedJournalQc":"","hasAnyPriority":false,"hideJournal":true,"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":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true},"keywords":"Ankle Fractures, Acupuncture Points, Xuehai (SP10), Herbal Medicine, Edema, Pain","lastPublishedDoi":"10.21203/rs.3.rs-6639301/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-6639301/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eObjective\u003c/strong\u003e​ To evaluate the clinical efficacy of herbal patch application at Xuehai acupoint (SP10) in reducing perioperative swelling and alleviating pain in patients undergoing ankle fracture surgery.\u003c/p\u003e\n\u003cp\u003e​\u003cstrong\u003eMethods\u003c/strong\u003e​ This randomized controlled trial enrolled 80 patients with ankle fractures admitted to the Department of Orthopedic Trauma at Dalian University Affiliated Zhongshan Hospital between July 2020 and September 2022. Participants were randomly divided into control (n=40) and intervention (n=40)groups. The control group received standard interventions, including intermittent cold therapy, limb elevation, and functional exercises. The intervention group received additional treatment with a customized traditional chinese herbal patch applied to SP10 ,which containing \u003cem\u003eSpatholobus stem\u003c/em\u003e (Jixueteng), \u003cem\u003eAtractylodes rhizome\u003c/em\u003e (Cangzhu), \u003cem\u003eChuanxiong rhizome\u003c/em\u003e (Chuanxiong), and \u003cem\u003eCorydalis tuber\u003c/em\u003e (Yanhusuo) . Outcomes including edema severity, NRS pain scores, ankle function (AOFAS score), and rescue NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) usage were assessed at postoperative days 1, 3, and 5.\u003c/p\u003e\n\u003cp\u003e​\u003cstrong\u003eResults\u003c/strong\u003e​ The intervention group demonstrated significantly reduced swelling (p\u0026lt;0.05) and lower pain scores (p\u0026lt;0.05) compared to the control group. Edema volume decreased from 4.68±0.66 cm (baseline) to 0.72±0.29 cm (day 5) in the herbal patch group versus 4.80±0.60 cm to 1.37±0.44 cm in controls, with faster edema resolution (80.23±6.33 vs. 96.63±4.78 hours, p\u0026lt;0.001). NRS pain scores improved markedly in the intervention group (day 5: 1.13±1.13 vs. 2.64±1.03, p\u0026lt;0.001). Both groups showed significant 8-week AOFAS score improvements (intervention: 79.96±6.34 vs. control: 76.83±6.51, p\u0026gt;0.05). No significant differences emerged in rescue NSAID usage (p\u0026gt;0.05), and both protocols were well-tolerated without severe adverse events.\u003c/p\u003e\n\u003cp\u003e​\u003cstrong\u003eConclusion\u003c/strong\u003e​ Herbal patch therapy at Xuehai acupoint (SP10) effectively mitigates post-fracture edema and pain, likely through its meridian-activating and stasis-resolving properties. This non-invasive approach, avoiding direct application to the injured site, offers a safe and practical adjunct to conventional perioperative care. While promising, this pilot study warrants validation through larger-scale trials with extended follow-up periods to confirm long-term benefits.\u003c/p\u003e","manuscriptTitle":"Effect of Xuehai Acupoint (SP10) Herbal Application on Swelling and Analgesia in Ankle Fracture Patients A Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-06-09 11:18:41","doi":"10.21203/rs.3.rs-6639301/v1","editorialEvents":[{"type":"communityComments","content":0}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"researchsquare","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":true,"externalIdentity":"","sideBox":"","snPcode":"","submissionUrl":"/submission","title":"Research Square","twitterHandle":"researchsquare","acdcEnabled":true,"dfaEnabled":false,"editorialSystem":"","reportingPortfolio":"","inReviewEnabled":false,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"66d8a281-2552-4958-a4e8-6356db9ac652","owner":[],"postedDate":"June 9th, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"posted","subjectAreas":[],"tags":[],"updatedAt":"2025-06-21T16:23:10+00:00","versionOfRecord":[],"versionCreatedAt":"2025-06-09 11:18:41","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-6639301","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-6639301","identity":"rs-6639301","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}