Culturally Adapted Pain Science Education (PSE) for Chronic Low Back Pain in India: A feasibility Randomized Controlled Trial

Culturally Adapted Pain Science Education (PSE) for Chronic Low Back Pain in India: A feasibility 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 Culturally Adapted Pain Science Education (PSE) for Chronic Low Back Pain in India: A feasibility Randomized Controlled Trial V Selva Ganapathy, Mariamma Philp, Palani Velu, Nupur Pruthi MCh, and 2 more This is a preprint; it has not been peer reviewed by a journal. https://doi.org/ 10.21203/rs.3.rs-7129655/v1 This work is licensed under a CC BY 4.0 License Status: Under Review Version 1 posted 9 You are reading this latest preprint version Abstract Background : Chronic Low back pain (CLBP) is highly prevalent and results in socioeconomic burden to an individual and to the government as there is an increased health care cost. As the pathology of CLBP is confined with hyper sensitivity of central nervous system leads to produce amplified pain response for a relatively suboptimal stimulus. The characteristic attitude of overprotection by an individual with low back pain (LBP) too contribute towards the mechanism of central hypersensitivity. Pain Science Education (PSE) along with graded exposure of physical activity and exercise are consider to be an effective intervention for CLBP. However, the content of PSE needs to be translated and culturally validated to suit to the local population. In India, for the first time such work has been completed, but feasibility to conduct a Randomized Controlled trial using the newly developed PSE education has not been completed. This study has been planned to fill the gap in research. Methodology : It’s an assessor-blinded feasibility randomized controlled trial (RCT),which included patients with CLBP with the duration of more than three months from the age group above 18 years and patients with additional comorbidity such as Severe psychiatric conditions (e.g., severe depression, schizophrenia)acute medical conditions preventing physical activity, neurological deficits or cognitive impairments, recent surgery or trauma affecting the back (within six months),Pregnancy or postpartum within six months. Patients were randomly allotted to the either control group or experimental group., Control group received guideline based physiotherapy which includes assurance, patient education, back and core muscle exercise, walking for 30 minutes, the experimental group received Culturally validated Pain Science Education(PSE) for an hour and advised to recollect the points and to undergo thirty minutes of walking every day for about 30 minutes, the feasibility criteria which includes Recruitment rate,acceptability,adherence to intervention etc. Two secondary outcome measures were also applied namely, Numerical Pain Rating Scale and Rolland Morris Disability Index on day one and day seven. Results : This study has met the preset Recruitment rate of 80%, Acceptability by patients of about 75% and the adherence rate of 90%, also there was a preliminary effect of culturally developed PSE was found. Conclusion : In India, feasibility of pain science education (PSE) as an intervention for CLBP has been established and a preliminary result are in favor of PSE group, hence it may be considered as a main stream treatment utilizing the available resource developed. A definite trial to prove the efficacy of PSE in CLBP is warranted. Trial registration: Clinical Trials Registry India (CTRI), CTRI/2022/07/044069; prospectively registered on 15 July 2022. Chronic Low back Pain (CLBP) Pain Science Education (PSE) Central Hypersensitivity kinesiophobia & Cognitive distortion Figures Figure 1 Figure 2 Figure 3 Background Low back pain (LBP) is the primary contributor to years lived with disability (YLDs) on a global scale, with over 500 million prevalent cases reported in 2020 [ 1 ] . It significantly impacts physical and mental health and leads to reduced quality of life and productivity [ 2 ] , particularly in developing countries like India. [ 3 ] Chronic low back pain (CLBP) is characterized by nonspecific pain persisting for over three months, with central sensitization seen as the underlying pathology that prolongs suffering beyond typical tissue recovery. [ 4 ] The development of central sensitization involves a range of biopsychosocial factors which includes the person’s negative belief mechanism, maladaptive coping strategy, poor socioeconomical conditions, life stressors etc. [ 5 ] Hence chronic pain itself a disease rather than mere extend of acute pain [ 6 ] . Person suffer with CLBP exhibit fear of movement and avoid physical activity. [ 7 ] Also, they conceive a catastrophized way of thinking about the outcome, such cognitive distortion results in poor coping mechanism of pain. [ 8 ] A person with chronic low back pain (CLBP) generally believes there is a biomedical basis for their prolonged discomfort, frequently leading to many appointments in search of a diagnosis and appropriate treatment. [ 9 ][ 10 ] The following characteristics features do associate with CLBP I.e. stress, anxiety, insomnia, irritable bowel syndrome and depression. [ 11 ][ 12 ] It poses a great challenge to the physiotherapist in successful management of this condition. [ 13 ] The pathology centers on the insufficient understanding of pain production mechanisms, specifically the overprotective nervous system's role in generating pain and maladaptive coping strategies that intensify it. Therefore, interventions should prioritize imparting this knowledge, teaching effective coping mechanisms, and promoting gradual exposure to physical activity. [ 14 ] The clinical practice guidelines (CPG) and the World Health Organization (WHO) recommendations for chronic low back pain (CLBP) strongly advocate both pain education and psychosocial therapy. [ 15 ] . Despite the strong recommendation, physiotherapists in India still finds it extremely difficult to implement the same in their daily practice. [ 16 ] The rationale may be the absence of information generated and made accessible within the Indian context, as well as the lack of feasibility testing for implementation on the targeted patient group. Pain Science Education (PSE) is an intervention that effectively tackles misconceptions about pain, promoting coping strategies and functional outcomes. The objective of explaining the neurophysiological factors that contribute to pain is to enable the patient to reframe their perceptions of pain, thereby leading to a reduction in pain and disability. [ 17 ] [ 18 ] The delivery of PSE to the patients involves storytelling, metaphors, examples from life events in a culturally acceptable way. [ 19 ] However, current PSE initiatives predominantly stem from Western contexts and might not be swiftly practical for culturally diverse populations. Therefore, the cultural adaptation of PSE is essential to enhance its efficacy within the clinical setting. Associated initiations have been carried out in various nations. [ 20 ][ 21 ][ 22 ] In this line, recently, the work on cultural adaptation has been successfully accomplished by our team in three Indian languages and published elsewhere. [ 23 ] However, to confirm whether PSE can be accepted as an intervention by the patients and will there be any preliminary effect of it on Pain and disability reduction, a feasibility RCT study is warranted. Hence, the present study has been planned to test the feasibility of conducting RCT using the newly developed PSE material in CLBP patients of Indian population. Objective This study aimed to evaluate the feasibility of administering culturally adapted PSE as an intervention among the CLBP patients. Materials and Methods Study Design An assessor-blinded feasibility randomized controlled trial (RCT), registered under the Clinical Trials Registry - India (CTRI/2022/07/044069), was conducted at the physiotherapy outpatient department, National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, India from June 2022 to October 2022. Participants : Twenty-four patients with CLBP were enrolled from outpatient referrals at NIMHANS & Sanjay Gandhi Institute of orthopedics. Participants were randomly assigned using block randomization: PSE Group: n = 12 Control Group: n = 12 Inclusion Criteria Age between 18 to 70 years CLBP persisting beyond 3 months Keel STarT sub-score > 3 Effective communication in regional languages (Kannada, Hindi, or English) Willingness for regular participation and follow-ups Exclusion Criteria Severe psychiatric conditions (e.g., severe depression, schizophrenia) Acute medical conditions preventing physical activity Neurological deficits or cognitive impairments Recent surgery or trauma affecting the back (within six months) Pregnancy or postpartum within six months Intervention The PSE group received: A structured, individualized sixty minutes of education session utilizing culturally adapted PSE booklet developed by NIMHANS team delivered by a trained physiotherapist. Overall, six session on an alternative day for two weeks have been conducted. In the home program, PSE booklet (language appropriate) was provided as a home guide to reinforce key educational messages taught in the intervention session, also, thirty minutes of walking with self-selected speed was advised. The control group received: Standard guideline-based physiotherapy, including back strengthening exercises -thirty minutes, Hot pack for about ten minutes, general back-care advice -ten minutes, and general pain education-10 minutes together as a package for about an hour on alternative day for two weeks, thirty minutes walking with self-selected speed as a home program also advised. Outcome Measures The following feasibility and acceptability outcomes were evaluated. Recruitment process Total number of people identified directly and through referrals, invited, screened, found/not found eligible, those who were willing to participate and those who declined the study invitation Self-reported acceptability of random allocation into groups Acceptability of interventions Perceived usefulness and satisfaction with the interventions at the 2 nd week post- intervention Self-reported intervention adherence at 2 nd week Perceived confidence in understanding of interventions at the end of 2 nd week Self-reported adverse events after receiving PSE interventions at 2 nd weeks post- intervention Self-reported improvement at two weeks Participant retention Those who started the interventions, completed/not completed; those who discontinued the intervention or withdrawn from the trial Intervention delivery: Number of intervention sessions delivered (N) Number of intervention sessions cancelled/rescheduled with reasons (N) Time spent with participants during each intervention session (Minutes) Therapists’ perceived usefulness of the intervention sessions (Likert scale) Therapists’ perceived difficulty in delivering the interventions (Likert scale) Therapists’ feedback on the content of PSE delivered (Free text) Time taken to complete patient-reported questionnaires at the end of one week; those who completed/not completed; missing data Secondary outcomes were assessed at baseline and post-intervention : Numeric Pain Rating Scale (NPRS): Pain intensity from 0 (no pain) to 10 (worst pain imaginable). Roland-Morris Disability Questionnaire (RMQ)- Kannada & Hindi version: Functional disability associated with low back pain. Sample size The primary purpose of this trial is to evaluate the feasibility and acceptability of PSE in people with CLBP. We do not intend to evaluate the clinical effects of PSE and therefore no statistical comparison will be undertaken. Given the nature of the study objectives and constraints with funding, time and resources required, we propose a total sample size of 12 participants allocated to PSE and control group each as per guidance from the literature. [24] Recruitment Study participants were recruited from the community and outpatient units of neurosurgery and orthopedic departments at the NIMHANS hospital and Sanjay Gandhi institute of orthopedics respectively. Potential participants based on the eligibility criteria were identified by the physiotherapists of the trial team directly or through referrals from neurosurgery and orthopedic departments. The physiotherapists approached the potentially eligible patients and asked if they are interested in taking part in the study. Those who are interested were provided with the participant information leaflet. A full eligibility screening was then be conducted in those interested. Once found eligible, patients were asked to provide signed informed consent prior to enrolment and baseline assessment. Allocation We used a computer-based random number sequence generated by an independent staff not involved in the design and conduct of the trial. Participants were allocated to PSE or control groups in 1:1 ratio by a member of the research team using sequentially numbered, opaque sealed envelopes that was opened only after writing each participant name. Blinding Trial participants were blinded to the group allocation. Physiotherapists who delivered the Guideline based physiotherapy and PSE cannot be blinded; other members of the trial team who involved in data analysis and data management were also not blinded. An independent member of the trial team not involved in the recruitment process or delivery of interventions collected the self-reported data and remain blinded to group allocation. Trial participants were asked not to discuss about the intervention they received in the trial with the data collectors. Data collection methods The clinical outcomes were measured at baseline, at the end of first week of PSE and control group after receiving the interventions. Data collected using paper forms and if when not possible; the assessments was completed over the telephone. Figure 1 shows the timeline and the different data collected at different time points of the trial. Data management The research data was collected by two members of the trial team trained in receiving informed consent, data collection and management methods. All research data were de-identified using unique study codes and stored in a password protected Microsoft Excel master file. Group allocation details too removed. The signed consent forms were stored in both paper and digital formats. All paper documents were securely stored in a locked cabinet and all digital documents were stored in a secured network drive at the NIMHANS accessed only by the chief study investigator, data collectors and the data analyst. Data analysis The main purpose of the trial was to report the feasibility; therefore, any formal statistical analysis of outcomes was not undertaken due to small sample size. The report of the results is in number (examples: participants, adverse events, intervention sessions etc.); percentages (example: completion rates); frequency of responses; means and standard deviations; or median and inter-quartile range as appropriate. Randomization and Blinding Block randomization (block size of four) was utilized. Outcome assessors remained blinded to group allocations. Statistical Analysis Descriptive statistics summarized demographic and clinical characteristics. Changes in NPRS and RMQ were analyzed using Wilcoxon signed rank test, with significance at p<0.05. Results A total of 21 participants were enrolled 10 assigned to the experimental group and 11 to the control group. Baseline demographics were comparable between groups. The experimental cohort had a mean age of 40.6 ± 13.6 years (range 26 to 59), while the control cohort averaged 44.9 ± 18.8 years (range 19 to 75). Men predominated in both groups, comprising 60.0 percent (6/10) of the experimental group and 63.6 percent (7/11) of the control group, with the remaining participants identifying as women. Table 1 – Age distribution of experimental group Characteristic Experimental group (n = 10) Control group (n = 11) Age (years) Mean ± SD 40.6 ± 13.6 44.9 ± 18.8 Range 26–59 19–75 Gender, n (%) Male 6 (60.0%) 7 (63.6%) Female 4 (40.0%) 4 (36.4%) SD = standard deviation. Feasibility results: see Table 2 1)Recruitment Process Overall, fifty participants were contacted to participate the study, of which thirty participants were eligible for the study, further twenty-one patients completed the protocol, demonstrating intervention feasibility and adherence. The reasons for the dropout have been provided in the Fig. 1 Data Collection 2)Self-reported acceptability of random allocation into groups The mean time to complete the screening procedure was about thirty (30) minutes including the initial screening and baseline assessment. 3)Acceptability of interventions All participants were able to accept the intervention at the end of one-week intervention, from both groups except few in the experimental group, expressed that “ while the concept/theory was interesting but while I was in severe pain, I had to take medications so some practical tips should be given to get relief from pain” 4)Self-reported intervention adherence at the end of 2nd week All participants in control and experimental group were able to adhere to the intervention. 5)Perceived confidence in understanding of interventions at the end of 2nd week Each participant in the intervention group expressed that they were able to understand the concept very well, some of them appreciated that the information shared is very much relatable in their life circumstances and came forwarded to summarize the education program offered to them to ensure their understanding is correct, one person said that, after listening to the education program and applied it made me to think that when I am in Pain, I should not panic, rather I need to calm down . Another person said that, when pain increases, I need to say to myself that I am in good health, this pain is an over protective response of my brain, so I don’t have to worry. 6) Self-reported Adverse Event No adverse events reported from any group. 7)Self-reported improvement at the end of 2nd week -Both groups Expressed improvement in pain reduction. But PSE group felt confident in returning to work and physical activity. 8)Participant retention Out of the 12 participants started the interventions in each group, one from each group did not completed intervention due to personnel reason, hence they have withdrawn their consent to participate. 9) Intervention delivery: Number of intervention sessions delivered -6 session each on alternative days for two weeks for both groups Number of intervention sessions cancelled/rescheduled with reasons-Nil Time spent with participants during each intervention session-60 Minutes Therapists’ perceived usefulness of the intervention sessions – 100%, Therapists’ perceived difficulty in delivering the interventions -10% skill training on light cognitive behaviour therapy, patient counselling would help the therapist to execute it better. Therapists’ feedback on the content of PSE delivered - Excellent 10)Time taken to complete patient-reported questionnaires at the end of one week; 20 minutes Table 2. Feasibility outcome results SL No. Feasibility outcomes Experimental N (%) Control N (%) p-value Result 1 Recruitment rate 12 (100) 12 (100) N/A 3 per month 2 Retention at twelve weeks 11 of 12 (92) 11 of 12 (92) 1.000 87% 3 Acceptability of random allocation 12 of 12 (100) 12 of 12 (100) 1.000 95 % a. Mean time to complete screening procedure 30 Minutes 30 Minutes - Including the initial screening and baseline assessment 4 Acceptability of interventions 10 of 12 (83) 11 of 12 (92) 1.000 95 % 5 Intervention adherence at two weeks 10 of 10 (100) 11 of 11 (100) 1.000 100 % 6 Confidence in understanding interventions 10 of 10 (100) 11 of 11 (100) 1.000 100 % 7 Adverse events 0 of 12 (0) 0 of 12 (0) 1.000 Criteria met 8 Self-reported improvement at two weeks 11 of 11 (100) 11 of 11 (100) 1.000 100 % 9 Intervention delivery fidelity 60 of 66 (91) 66 of 66 (100) 1.000 Criteria met a. Number of intervention sessions delivered 60 66 - six sessions in two weeks for both groups b. Number of sessions cancelled or rescheduled 6 0 - Criteria met c. Time spent per session 60 minutes 60minutes - 60 minutes d. Therapists perceived usefulness extremely useful - - e. Therapists perceived difficulty somewhat difficult 5/5- - f. Therapists feedback on content excellent 5/5 - 10 Questionnaire completion rate 11 of 11 (100) 11 of 11 (100) 1.000 100% a. Time to complete questionnaires 20 minutes 20 minutes - Secondary outcome results: Significant improvements in pain (NPRS) and functional disability (RMQ) were observed in both groups. The PSE group(N=10) exhibited superior outcomes I.e. NPRS scores decreased significantly from 6.00±2.49 to 4.40±2.31 (p=0.016), and RMQ scores from 12.00±5.69 to 10.00±4.97 (p=0.026). Comparatively, the control group improved from 5.73±1.67 to 4.55±1.36 (p=0.010) on NPRS and from 9.45±4.08 to 8.27±4.59 (p=0.016) on RMQ. Percentage improvements favoured the PSE group (27% pain, 17% disability) versus control (20% pain, 12% disability), highlighting the additional benefit of integrating Pain science education strategies with conventional physiotherapy. However, there was no significant difference observed between groups. Fig:2&3 Discussion After successfully developing culturally adapted Pain Science Education (PSE) in Indian languages, this study serves as a critical second step by evaluating the feasibility, acceptability, and preliminary effectiveness of this intervention for reducing pain intensity and disability among patients with CLBP in India. Our culturally tailored approach notably enhanced patient comprehension and acceptance, aligning with global evidence advocating culturally sensitive educational interventions. This finding resonates with international research underscoring the importance of culturally contextualized education in chronic pain management. [ 25 ] Similar results have been documented in various geographic contexts, emphasizing the importance of cultural adaptations. For example, Sharma et al. [ 26 ] reported comparable outcomes in Nepal, demonstrating significant patient engagement and understanding following culturally adapted pain education. Our attrition rate was higher compared to Nepal study studies, they recorded a lower attrition rate, largely attributed to the single-session format. Moreover, research from Spain provides additional comparative insights highlighted that patient receiving culturally adapted educational interventions exhibited improved adherence and satisfaction compared to generic educational content [ 27 ] . Similar to our findings, the Spanish study underscored the necessity of integrating culturally relevant examples and metaphors, but differences arose in patient adherence patterns, partly explained by differing cultural expectations around healthcare interactions. Unlike the single-session delivery utilized in Nepal, multiple sessions in the Spanish context allowed gradual patient assimilation of information, echoing our methodology. This suggests that structured multiple-session formats, despite increased risk of attrition, may offer cumulative educational benefits and facilitate behavioural changes. An essential insight from our study pertains to participant adherence and the implications for attrition. We noted that improved patient condition occasionally resulted in early withdrawal, a phenomenon also observed internationally [ 28 ] This behaviour underscores the necessity of patient education about maintaining consistent intervention schedules, even when symptomatic relief occurs prematurely, ensuring sustained long-term benefits. Addressing feasibility specifically, our study demonstrated an adequate recruitment rate and high retention, meeting a post-hoc criterion of at least 85%. Nonetheless, further efforts to broaden recruitment outreach could bolster future studies, particularly considering diverse regional settings within India. Retention strategies employed internationally, such as regular follow-up reminders or digital engagement tools (e.g., mobile applications), might further enhance participant retention. The methodological rigor employed herein underscores strong acceptance across varied educational backgrounds among participants, substantiating the adaptability of PSE as a standard care intervention for Indian CLBP populations. However, feedback indicating a demand for more practical pain-management tips necessitates augmenting future interventions with concrete self-management strategies and practical cognitive-behavioural techniques. Such enhancements would not only align with global multidisciplinary pain management recommendations but also potentially elevate patient satisfaction and adherence. Furthermore, our findings highlight the therapist’s role and required attributes for effective intervention delivery. Therapists underscored the importance of empathy, compassion, patient-centric listening skills, and basic counselling competencies, reinforcing international recommendations for therapist training [ 29 ] These qualitative insights are valuable for refining future training curricula and optimizing therapist preparedness, subsequently enhancing patient-therapist interactions and overall therapeutic outcomes. A distinctive aspect of this study involves the integration of self-management components such as positive affirmations and cognitive reorientation, aligning closely with global trends advocating comprehensive biopsychosocial management frameworks. For instance, international guidelines such as those from the International Association for the Study of Pain (IASP) and NICE consistently emphasize psychological factors and cognitive strategies as core components of chronic pain management [ 30 ] ,By incorporating these elements into physiotherapeutic practice, our study uniquely contributes to evidence supporting holistic and integrative chronic pain care models. Despite encouraging preliminary outcomes, several limitations warrant acknowledgment. Our relatively small sample size, inherent to feasibility studies, restricts generalizability. Additionally, longer-term follow-up periods extending beyond two weeks are crucial to assess sustained intervention impacts fully. Future large-scale randomized controlled trials with extended follow-up intervals are essential to validate these promising preliminary results conclusively and could significantly influence both clinical practice and national chronic pain management guidelines in India. This feasibility study demonstrates the promising potential of culturally adapted PSE interventions in the Indian context, supporting their acceptability, comprehension, and initial effectiveness. Comparison with international studies highlights both shared challenges and unique cultural distinctions, underscoring the necessity for continued culturally sensitive adaptations. Future research should prioritize integrating practical behavioural strategies and sustained cognitive-behavioural support, ultimately aiming to enhance long-term patient outcomes and adherence. Strengths of the study This is the first feasibility RCT study on PSE for CLBP conducted in India, Considering India has a diverse cultural, socio-economic and educational background, education as a primary intervention has been attempted and found it’s well accepted, hence a full scale RCT can be conducted to test its efficacy. This study has also revealed the expectations of patients in terms of a need for a practical tip as a part of pain science education is a unique addendum. Similarly, as per the therapist’s feedback/observation, enabling the patient to ventilate their life stress by being an active listener and express empathy towards the patient to be worth noted and incorporated in the future studies. Limitation of the study The results of the secondary outcome measures cannot be weighted as the sample size is small. Conclusion The Feasibility RCT trial demonstrates that culturally adapted Pain Science Education (PSE) is well received and showed a preliminary effect in reducing pain and disability among Indian patients with chronic low back pain. Larger-scale studies are warranted to confirm these findings and facilitate integration into clinical practice guidelines. Abbreviations CBT – Cognitive Behavioural Therapy CLBP – Chronic Low Back Pain CONSORT – Consolidated Standards of Reporting Trials CPG – Clinical Practice Guideline CTRI – Clinical Trials Registry–India IEC – Institutional Ethics Committee IQR – Interquartile Range LBP – Low Back Pain NIMHANS – National Institute of Mental Health & Neurosciences NPRS – Numeric Pain Rating Scale PSE – Pain Science Education RCT – Randomized Controlled Trial RMQ – Roland-Morris Disability Questionnaire RDI – Roland Disability Index (alternative name for RMQ) RAG – Red–Amber–Green feasibility status rating SD – Standard Deviation SGIOT – Sanjay Gandhi Institute of Orthopaedics & Traumatology STarT – Keele STarT Back Screening Tool WHO – World Health Organization YLDs – Years Lived with Disability Declarations Ethical Considerations All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. The study protocol was approved by the Institutional Ethics Committee of NIMHANS. Written informed consent was obtained from all participants. Availability of data and materials The de‑identified datasets generated and analyzed during the current study are available from the corresponding author on reasonable request. Competing interests The authors declare that they have no competing interests. Funding This research received no specific grant from any funding agency in the public, commercial or not‑for‑profit sectors. Consent for publication Not applicable. The manuscript does not contain any individual person’s identifiable data in any form. Authors’ contributions VSG conceived the study and secured ethics approval. VSG and CS designed the protocol. PV and VSG administered the interventions and collected data. MP managed data entry and performed the statistical analysis. VSG & MS drafted the manuscript. NP and MP critically revised the manuscript for important intellectual content. All authors read and approved the final manuscript. Acknowledgements The authors thank Dr Vasanthan R (Oxford College of Physiotherapy), Dr P Antony Leo Aseer (Sri Ramachandra Institute of Higher Education and Research), Dr Pradnya Dhargave, Dr Dhaval Shukla, and the physiotherapy interns at NIMHANS for their valuable assistance during the study. References GBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990–2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023;5(6):e316-e329. Published 2023 May 22. 10.1016/S2665-9913(23)00098-X Saxena AK, Jain PN, Bhatnagar S. The Prevalence of Chronic Pain among Adults in India. Indian J Palliat Care. 2018;24(4):472–7. 10.4103/IJPC.IJPC_141_18 . Ge L, Pereira MJ, Yap CW, Heng BH. Chronic low back pain and its impact on physical function, mental health, and health-related quality of life: a cross-sectional study in Singapore. Sci Rep. 2022;12(1):20040. Published 2022 Nov 21. 10.1038/s41598-022-24703-7 Latremoliere A, Woolf CJ. Central sensitization: a generator of pain hypersensitivity by central neural plasticity. J Pain. 2009;10(9):895–926. 10.1016/j.jpain.2009.06.012 . Meints SM, Edwards RR. Evaluating psychosocial contributions to chronic pain outcomes. Prog Neuropsychopharmacol Biol Psychiatry. 2018;87(Pt B):168–82. 10.1016/j.pnpbp.2018.01.017 . Scholz J, Woolf CJ. Can we conquer pain? Nat Neurosci. 2002;5:1062–7. 10.1038/nn942 . De Ridder D, Adhia D, Vanneste S. The anatomy of pain and suffering in the brain and its clinical implications. Neurosci Biobehav Rev. 2021;130:125–46. 10.1016/j.neubiorev.2021.08.013 . Larsson C, Ekvall Hansson E, Sundquist K, Jakobsson U. Impact of pain characteristics and fear-avoidance beliefs on physical activity levels among older adults with chronic pain: a population-based, longitudinal study. BMC Geriatr. 2016;16:50. 10.1186/s12877-016-0224-3 . Published 2016 Feb 24. Bonfim IDS, Corrêa LA, Nogueira LAC, Meziat-Filho N, Reis FJJ, de Almeida RS. Your spine is so worn out' - the influence of clinical diagnosis on beliefs in patients with non-specific chronic low back pain - a qualitative study. Braz J Phys Ther. 2021;25(6):811–8. 10.1016/j.bjpt.2021.07.001 . Haldeman S, Dagenais S. A supermarket approach to the evidence-informed management of chronic low back pain. Spine J. 2008;8(1):1–7. 10.1016/j.spinee.2007.10.009 . Jiang H, Zhang X, Liang J. The Combined Effect Between Sleep Disorders and Depression Symptoms on Chronic Low Back Pain: A Cross-Sectional Study of NHANES. J Pain Res. 2024;17:2777–87. 10.2147/JPR.S471401 . Published 2024 Aug 26. Falling C, Stebbings S, Baxter GD, et al. Symptoms of central sensitization in patients with inflammatory bowel diseases: a case-control study examining the role of musculoskeletal pain and psychological factors. Scand J Pain. 2020;21(2):283–95. 10.1515/sjpain-2020-0109 . Published 2020 Oct 28. Beissner K, Henderson CR Jr, Papaleontiou M, Olkhovskaya Y, Wigglesworth J, Reid MC. Physical therapists’ use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. Phys Ther. 2009;89(5):456–69. 10.2522/ptj.20080163 . pubmed.ncbi.nlm.nih.gov . Nijs J, Clark J, Malfliet A, et al. In the spine or in the brain? Recent advances in pain neuroscience applied in the intervention for low back pain. Clin Exp Rheumatol. 2017;35(Suppl 107):108–15. https://www.who.int/publications/i/item/9789240081789 Ganesh GS, Khan AR, Khan A. Factors contributing to non-compliance with active physiotherapy guidelines among chronic low back pain patients in India. Arch Physiother. 2024;14:155–69. 10.33393/aop.2024.3217 . PMID: 39777288; PMCID: PMC11704684. Watson JA, Ryan CG, Cooper L, et al. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019;20(10):1140. .e1-1140.e22. Louw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011;92(12):2041–56. 10.1016/j.apmr.2011.07.198 . Louw A, Puentedura EJ, Diener I, Zimney KJ, Cox T. Pain neuroscience education: Which pain neuroscience education metaphor worked best? S Afr J Physiother. 2019;75(1):1329. Published 2019 Aug 13. 10.4102/sajp.v75i1.1329 Sharma S, Jensen MP, Moseley GL, et al. Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial. BMJ Open. 2019;9(3):e026874. 10.1136/bmjopen-2018-026874 . Mukhtar NB, Meeus M, Gursen C, et al. Development of culturally sensitive pain neuroscience education materials for Hausa-speaking patients with chronic spinal pain: A modified Delphi study. PLoS ONE. 2021;16(7):e0253757. 10.1371/journal.pone.0253757 . Orhan C, Cagnie B, Favoreel A, et al. Development of culturally sensitive Pain Neuroscience Education for first-generation Turkish patients with chronic pain: a modified Delphi study. Musculoskelet Sci Pract. 2019;39:1–9. 10.1016/j.msksp.2018.10.007 . Selva Ganapathy V, Desai G, Krishnamurthy L, Manjula M, Banu MR, Sharma S. (2025). Development of pain science education for chronic low back pain in India. J Man Manipulative Therapy, 1–7. Abbott JH. The distinction between randomized clinical trials (RCTs) and preliminary feasibility and pilot studies: what they are and are not. J Orthop Sports Phys Ther. 2014;44:555–8. Cipta DA, Andoko D, Theja A, et al. Culturally sensitive patient-centered healthcare: a focus on health behavior modification in low and middle-income nations-insights from Indonesia. Front Med (Lausanne). 2024;11:1353037. 10.3389/fmed.2024.1353037 . Published 2024 Apr 12. Sharma S, Jensen MP, Moseley GL, et al. Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial. BMJ Open. 2019;9(3):e026874. 10.1136/bmjopen-2018-026874 . Navarro-Brazález B, Vergara-Pérez F, Prieto-Gómez V, Sánchez-Sánchez B, Yuste-Sánchez MJ, Torres-Lacomba M. What influences women to adhere to pelvic floor exercises after physiotherapy treatment? A qualitative study for individualized pelvic health care. J Pers Med. 2021;11(12):1368. 10.3390/jpm11121368 . pmc.ncbi.nlm.nih.gov . Beeckman M, Hughes S, Van der Kaap-Deeder J, Plasschaert F, Michielsen J, Moens P, et al. Risk and resilience predictors of recovery after spinal fusion surgery in adolescents. Clin J Pain. 2021;37(11):789–802. pubmed.ncbi.nlm.nih.gov . Hutson H, Louw A, Puentedura EJ, Zimney K. Therapist empathy, compassion and patient-centred communication skills for delivering pain neuroscience education: a Delphi consensus study. Musculoskelet Sci Pract. 2019;42:51–9. Raja SN, Carr DB, Cohen M, et al. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020;161(9):1976–82. 10.1097/j.pain.0000000000001939 . Additional Declarations No competing interests reported. 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Ganapathy","email":"data:image/png;base64,iVBORw0KGgoAAAANSUhEUgAAAZAAAAAyAQMAAABI0h/eAAAABlBMVEX///8AAABVwtN+AAAACXBIWXMAAA7EAAAOxAGVKw4bAAAA6ElEQVRIiWNgGAWjYFAC5gYGhgqb+sZ2IM1gYEGMFkag0jNpjM09B0BaJIjUwth2mLF9RgKIR4QW+fbGNokfbMzMvDOfX93wo0CCgb+9OwGvFoMzB9ske3jY2CRn55Td7AE6TOLM2Q34tUgkNhvwSPDwGM7OSbvBA9RiIJGLX4v8/IfNhn8MJCTsb55Ju/mHGC0MNxgbH/MkGBgwzmA/dpsoWwzOJDY+ljmQkMDYk8N2W8ZAgoegX+TbDx84+Pbf/wTG9uPPbr75YyPH395LwGEIwGMAJolVDgLsD0hRPQpGwSgYBSMIAAA3OEooAFFLVQAAAABJRU5ErkJggg==","orcid":"","institution":"National Institute of Mental Health \u0026 Neurosciences(NIMHANS)","correspondingAuthor":true,"prefix":"","firstName":"V","middleName":"Selva","lastName":"Ganapathy","suffix":""},{"id":504123993,"identity":"de4d103a-f442-4251-9d8e-85332a42674c","order_by":1,"name":"Mariamma Philp","email":"","orcid":"","institution":"National Institute of Mental Health \u0026 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Oxford","correspondingAuthor":false,"prefix":"","firstName":"Cynthia","middleName":"","lastName":"Srikesavan","suffix":""},{"id":504124003,"identity":"b02a3880-c9a7-4c8c-8e57-a7f68077cadf","order_by":5,"name":"Mayank Sharma","email":"","orcid":"","institution":"National Institute of Mental Health \u0026 Neurosciences(NIMHANS)","correspondingAuthor":false,"prefix":"","firstName":"Mayank","middleName":"","lastName":"Sharma","suffix":""}],"badges":[],"createdAt":"2025-07-15 10:53:07","currentVersionCode":1,"declarations":"","doi":"10.21203/rs.3.rs-7129655/v1","doiUrl":"https://doi.org/10.21203/rs.3.rs-7129655/v1","draftVersion":[],"editorialEvents":[],"editorialNote":"","failedWorkflow":false,"files":[{"id":90299654,"identity":"a84977cf-bd0b-4f66-9b32-f33b5f5cfcf0","added_by":"auto","created_at":"2025-09-01 08:51:59","extension":"png","order_by":1,"title":"Figure 1","display":"","copyAsset":false,"role":"figure","size":21510,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eCONSORT FLOW-Recruitment\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"1.png","url":"https://assets-eu.researchsquare.com/files/rs-7129655/v1/3da02beb5acb577a24252539.png"},{"id":90301543,"identity":"a92ba1d2-8db4-4165-848c-c001b488bd81","added_by":"auto","created_at":"2025-09-01 08:59:59","extension":"png","order_by":2,"title":"Figure 2","display":"","copyAsset":false,"role":"figure","size":10348,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eChange in RMQ across time in both the groups\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"2.png","url":"https://assets-eu.researchsquare.com/files/rs-7129655/v1/a8b82e27f92808a8e6e77deb.png"},{"id":90302321,"identity":"e4a6b716-f4ef-45dd-94b2-667135d725bc","added_by":"auto","created_at":"2025-09-01 09:07:59","extension":"png","order_by":3,"title":"Figure 3","display":"","copyAsset":false,"role":"figure","size":9370,"visible":true,"origin":"","legend":"\u003cp\u003e\u003cstrong\u003eChanges in NRPS across time in both groups\u003c/strong\u003e\u003c/p\u003e","description":"","filename":"3.png","url":"https://assets-eu.researchsquare.com/files/rs-7129655/v1/cda18ec3055cfb5ca9ac6279.png"},{"id":90304372,"identity":"0738e3c5-d59c-4ad3-ba69-c72c6033b3da","added_by":"auto","created_at":"2025-09-01 09:15:59","extension":"pdf","order_by":0,"title":"","display":"","copyAsset":false,"role":"manuscript-pdf","size":1115544,"visible":true,"origin":"","legend":"","description":"","filename":"manuscript.pdf","url":"https://assets-eu.researchsquare.com/files/rs-7129655/v1/add98ae3-4e57-4001-a8f4-b5d5dbc99ffa.pdf"}],"financialInterests":"No competing interests reported.","formattedTitle":"Culturally Adapted Pain Science Education (PSE) for Chronic Low Back Pain in India: A feasibility Randomized Controlled Trial","fulltext":[{"header":"Background","content":"\u003cp\u003eLow back pain (LBP) is the primary contributor to years lived with disability (YLDs) on a global scale, with over 500\u0026nbsp;million prevalent cases reported in 2020\u003csup\u003e[\u003cspan citationid=\"CR1\" class=\"CitationRef\"\u003e1\u003c/span\u003e]\u003c/sup\u003e. It significantly impacts physical and mental health and leads to reduced quality of life and productivity \u003csup\u003e[\u003cspan citationid=\"CR2\" class=\"CitationRef\"\u003e2\u003c/span\u003e]\u003c/sup\u003e, particularly in developing countries like India.\u003csup\u003e[\u003cspan citationid=\"CR3\" class=\"CitationRef\"\u003e3\u003c/span\u003e]\u003c/sup\u003e Chronic low back pain (CLBP) is characterized by nonspecific pain persisting for over three months, with central sensitization seen as the underlying pathology that prolongs suffering beyond typical tissue recovery.\u003csup\u003e[\u003cspan citationid=\"CR4\" class=\"CitationRef\"\u003e4\u003c/span\u003e]\u003c/sup\u003eThe development of central sensitization involves a range of biopsychosocial factors which includes the person\u0026rsquo;s negative belief mechanism, maladaptive coping strategy, poor socioeconomical conditions, life stressors etc.\u003csup\u003e[\u003cspan citationid=\"CR5\" class=\"CitationRef\"\u003e5\u003c/span\u003e]\u003c/sup\u003e Hence chronic pain itself a disease rather than mere extend of acute pain\u003csup\u003e[\u003cspan citationid=\"CR6\" class=\"CitationRef\"\u003e6\u003c/span\u003e]\u003c/sup\u003e. Person suffer with CLBP exhibit fear of movement and avoid physical activity. \u003csup\u003e[\u003cspan citationid=\"CR7\" class=\"CitationRef\"\u003e7\u003c/span\u003e]\u003c/sup\u003e Also, they conceive a catastrophized way of thinking about the outcome, such cognitive distortion results in poor coping mechanism of pain. \u003csup\u003e[\u003cspan citationid=\"CR8\" class=\"CitationRef\"\u003e8\u003c/span\u003e]\u003c/sup\u003e A person with chronic low back pain (CLBP) generally believes there is a biomedical basis for their prolonged discomfort, frequently leading to many appointments in search of a diagnosis and appropriate treatment. \u003csup\u003e[\u003cspan citationid=\"CR9\" class=\"CitationRef\"\u003e9\u003c/span\u003e][\u003cspan citationid=\"CR10\" class=\"CitationRef\"\u003e10\u003c/span\u003e]\u003c/sup\u003e The following characteristics features do associate with CLBP I.e. stress, anxiety, insomnia, irritable bowel syndrome and depression. \u003csup\u003e[\u003cspan citationid=\"CR11\" class=\"CitationRef\"\u003e11\u003c/span\u003e][\u003cspan citationid=\"CR12\" class=\"CitationRef\"\u003e12\u003c/span\u003e]\u003c/sup\u003e It poses a great challenge to the physiotherapist in successful management of this condition.\u003csup\u003e[\u003cspan citationid=\"CR13\" class=\"CitationRef\"\u003e13\u003c/span\u003e]\u003c/sup\u003e The pathology centers on the insufficient understanding of pain production mechanisms, specifically the overprotective nervous system's role in generating pain and maladaptive coping strategies that intensify it. Therefore, interventions should prioritize imparting this knowledge, teaching effective coping mechanisms, and promoting gradual exposure to physical activity.\u003csup\u003e[\u003cspan citationid=\"CR14\" class=\"CitationRef\"\u003e14\u003c/span\u003e]\u003c/sup\u003e The clinical practice guidelines (CPG) and the World Health Organization (WHO) recommendations for chronic low back pain (CLBP) strongly advocate both pain education and psychosocial therapy. \u003csup\u003e[\u003cspan citationid=\"CR15\" class=\"CitationRef\"\u003e15\u003c/span\u003e]\u003c/sup\u003e. Despite the strong recommendation, physiotherapists in India still finds it extremely difficult to implement the same in their daily practice. \u003csup\u003e[\u003cspan citationid=\"CR16\" class=\"CitationRef\"\u003e16\u003c/span\u003e]\u003c/sup\u003e The rationale may be the absence of information generated and made accessible within the Indian context, as well as the lack of feasibility testing for implementation on the targeted patient group. Pain Science Education (PSE) is an intervention that effectively tackles misconceptions about pain, promoting coping strategies and functional outcomes. The objective of explaining the neurophysiological factors that contribute to pain is to enable the patient to reframe their perceptions of pain, thereby leading to a reduction in pain and disability. \u003csup\u003e[\u003cspan citationid=\"CR17\" class=\"CitationRef\"\u003e17\u003c/span\u003e] [\u003cspan citationid=\"CR18\" class=\"CitationRef\"\u003e18\u003c/span\u003e]\u003c/sup\u003e The delivery of PSE to the patients involves storytelling, metaphors, examples from life events in a culturally acceptable way. \u003csup\u003e[\u003cspan citationid=\"CR19\" class=\"CitationRef\"\u003e19\u003c/span\u003e]\u003c/sup\u003e However, current PSE initiatives predominantly stem from Western contexts and might not be swiftly practical for culturally diverse populations. Therefore, the cultural adaptation of PSE is essential to enhance its efficacy within the clinical setting. Associated initiations have been carried out in various nations. \u003csup\u003e[\u003cspan citationid=\"CR20\" class=\"CitationRef\"\u003e20\u003c/span\u003e][\u003cspan citationid=\"CR21\" class=\"CitationRef\"\u003e21\u003c/span\u003e][\u003cspan citationid=\"CR22\" class=\"CitationRef\"\u003e22\u003c/span\u003e]\u003c/sup\u003e In this line, recently, the work on cultural adaptation has been successfully accomplished by our team in three Indian languages and published elsewhere.\u003csup\u003e[\u003cspan citationid=\"CR23\" class=\"CitationRef\"\u003e23\u003c/span\u003e]\u003c/sup\u003e However, to confirm whether PSE can be accepted as an intervention by the patients and will there be any preliminary effect of it on Pain and disability reduction, a feasibility RCT study is warranted. Hence, the present study has been planned to test the feasibility of conducting RCT using the newly developed PSE material in CLBP patients of Indian population.\u003c/p\u003e\u003cp\u003e\u003cb\u003eObjective\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis study aimed to evaluate the feasibility of administering culturally adapted PSE as an intervention among the CLBP patients.\u003c/p\u003e"},{"header":"Materials and Methods","content":"\u003cp\u003e\u003cb\u003eStudy Design\u003c/b\u003e\u003c/p\u003e\u003cp\u003eAn assessor-blinded feasibility randomized controlled trial (RCT), registered under the Clinical Trials Registry - India (CTRI/2022/07/044069), was conducted at the physiotherapy outpatient department, National Institute of Mental Health and Neurosciences (NIMHANS), Bengaluru, India from June 2022 to October 2022.\u003c/p\u003e\u003cp\u003e\u003cb\u003eParticipants\u003c/b\u003e:\u003c/p\u003e\u003cp\u003eTwenty-four patients with CLBP were enrolled from outpatient referrals at NIMHANS \u0026amp; Sanjay Gandhi Institute of orthopedics. Participants were randomly assigned using block randomization:\u003c/p\u003e\u003cp\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003ePSE Group: n\u0026thinsp;=\u0026thinsp;12\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eControl Group: n\u0026thinsp;=\u0026thinsp;12\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eInclusion Criteria\u003c/b\u003e\u003c/p\u003e\u003cp\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eAge between 18 to 70 years\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eCLBP persisting beyond 3 months\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eKeel STarT sub-score\u0026thinsp;\u0026gt;\u0026thinsp;3\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eEffective communication in regional languages (Kannada, Hindi, or English)\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eWillingness for regular participation and follow-ups\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eExclusion Criteria\u003c/b\u003e\u003c/p\u003e\u003cp\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eSevere psychiatric conditions (e.g., severe depression, schizophrenia)\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eAcute medical conditions preventing physical activity\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eNeurological deficits or cognitive impairments\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eRecent surgery or trauma affecting the back (within six months)\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003ePregnancy or postpartum within six months\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eIntervention\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe \u003cb\u003ePSE group\u003c/b\u003e received:\u003c/p\u003e\u003cp\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003eA structured, individualized sixty minutes of education session utilizing culturally adapted PSE booklet developed by NIMHANS team delivered by a trained physiotherapist. Overall, six session on an alternative day for two weeks have been conducted.\u003c/p\u003e\u003c/li\u003e\u003cli\u003e\u003cp\u003eIn the home program, PSE booklet (language appropriate) was provided as a home guide to reinforce key educational messages taught in the intervention session, also, thirty minutes of walking with self-selected speed was advised.\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e\u003cp\u003eThe \u003cb\u003econtrol group\u003c/b\u003e received:\u003c/p\u003e\u003cp\u003e\u003cul\u003e\u003cli\u003e\u003cp\u003e Standard guideline-based physiotherapy, including back strengthening exercises -thirty minutes, Hot pack for about ten minutes, general back-care advice -ten minutes, and general pain education-10 minutes together as a package for about an hour on alternative day for two weeks, thirty minutes walking with self-selected speed as a home program also advised.\u003c/p\u003e\u003c/li\u003e\u003c/ul\u003e\u003c/p\u003e\u003cp\u003e\u003cstrong\u003eOutcome Measures\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe following feasibility and acceptability outcomes were evaluated.\u003c/p\u003e\n\u003col\u003e\n \u003cli\u003eRecruitment process\u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003eTotal number of people identified directly and through referrals, invited, screened, found/not found eligible, those who were willing to participate and those who declined the study invitation\u0026nbsp;\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/li\u003e\n \u003cli\u003eSelf-reported acceptability of random allocation into groups\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eAcceptability of interventions\u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003ePerceived usefulness and satisfaction with the interventions at the 2\u003csup\u003end\u003c/sup\u003e week post- intervention\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/li\u003e\n \u003cli\u003eSelf-reported intervention adherence at 2\u003csup\u003end\u003c/sup\u003e week\u0026nbsp;\u003c/li\u003e\n \u003cli\u003ePerceived confidence in understanding of interventions at the end of 2\u003csup\u003end\u003c/sup\u003e week\u003c/li\u003e\n \u003cli\u003eSelf-reported adverse events after receiving PSE interventions at 2\u003csup\u003end\u003c/sup\u003e weeks post- intervention\u003c/li\u003e\n \u003cli\u003eSelf-reported improvement at two weeks\u0026nbsp;\u003c/li\u003e\n \u003cli\u003eParticipant retention\u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003eThose who started the interventions, completed/not completed; those who discontinued the intervention or withdrawn from the trial\u0026nbsp;\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/li\u003e\n \u003cli\u003eIntervention delivery:\u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003eNumber of intervention sessions delivered (N)\u003c/li\u003e\n \u003cli\u003eNumber of intervention sessions cancelled/rescheduled with reasons (N)\u003c/li\u003e\n \u003cli\u003eTime spent with participants during each intervention session (Minutes)\u003c/li\u003e\n \u003cli\u003eTherapists\u0026rsquo; perceived usefulness of the intervention sessions (Likert scale)\u003c/li\u003e\n \u003cli\u003eTherapists\u0026rsquo; perceived difficulty in delivering the interventions (Likert scale)\u003c/li\u003e\n \u003cli\u003eTherapists\u0026rsquo; feedback on the content of PSE delivered (Free text)\u003c/li\u003e\n \u003c/ol\u003e\n \u003c/li\u003e\n \u003cli\u003eTime taken to complete patient-reported questionnaires at the end of one week; those who completed/not completed; missing data\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003eSecondary outcomes were assessed at baseline and post-intervention\u003c/strong\u003e:\u003c/p\u003e\n\u003col start=\"1\" type=\"1\"\u003e\n \u003cli\u003eNumeric Pain Rating Scale (NPRS): Pain intensity from 0 (no pain) to 10 (worst pain imaginable).\u003c/li\u003e\n \u003cli\u003eRoland-Morris Disability Questionnaire (RMQ)- Kannada \u0026amp; Hindi version: Functional disability associated with low back pain.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003eSample size\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe primary purpose of this trial is to evaluate the feasibility and acceptability of PSE in people with CLBP. We do not intend to evaluate the clinical effects of PSE and therefore no statistical comparison will be undertaken. Given the nature of the study objectives and constraints with funding, time and resources required, we propose a total sample size of 12 participants allocated to PSE and control group each as per guidance from the literature.\u003csup\u003e\u0026nbsp;[24]\u003c/sup\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRecruitment\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eStudy participants were recruited from the community and outpatient units of neurosurgery and orthopedic departments at the NIMHANS hospital and Sanjay Gandhi institute of orthopedics respectively. Potential participants based on the eligibility criteria were identified by the physiotherapists of the trial team directly or through referrals from neurosurgery and orthopedic departments. \u0026nbsp;The physiotherapists approached the potentially eligible patients and asked if they are interested in taking part in the study. Those who are interested were provided with the participant information leaflet. A full eligibility screening was then be conducted in those interested. Once found eligible, patients were asked to provide signed informed consent prior to enrolment and baseline assessment.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAllocation\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eWe used a computer-based random number sequence generated by an independent staff not involved in the design and conduct of the trial. Participants were allocated to PSE or control groups in 1:1 ratio by a member of the research team using sequentially numbered, opaque sealed envelopes that was opened only after writing each participant name.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eBlinding\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eTrial participants were blinded to the group allocation. Physiotherapists who delivered the Guideline based physiotherapy and PSE cannot be blinded; other members of the trial team who involved in data analysis and data management were also not blinded.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eAn independent member of the trial team not involved in the recruitment process or delivery of interventions collected the self-reported data and remain blinded to group allocation. Trial participants were asked not to discuss about the intervention they received in the trial with the data collectors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData collection methods\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe clinical outcomes were measured at baseline, at the end of first week of PSE and control group after receiving the interventions. Data collected using paper forms and if when not possible; the assessments was completed over the telephone. Figure 1 shows the timeline and the different data collected at different time points of the trial.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData management\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe research data was collected by two members of the trial team trained in receiving informed consent, data collection and management methods. All research data were de-identified using unique study codes and stored in a password protected Microsoft Excel master file. Group allocation details too removed. The signed consent forms were stored in both paper and digital formats. All paper documents were securely stored in a locked cabinet and all digital documents were stored in a secured network drive at the NIMHANS accessed only by the chief study investigator, data collectors and the data analyst.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eData analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe main purpose of the trial was to report the feasibility; therefore, any formal statistical analysis of outcomes was not undertaken due to small sample size. The report of the results is in number (examples: participants, adverse events, intervention sessions etc.); percentages (example: completion rates); frequency of responses; means and standard deviations; or median and inter-quartile range as appropriate.\u0026nbsp;\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eRandomization and Blinding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eBlock randomization (block size of four) was utilized. Outcome assessors remained blinded to group allocations.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eStatistical Analysis\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eDescriptive statistics summarized demographic and clinical characteristics. Changes in NPRS and RMQ were analyzed using Wilcoxon signed rank test, with significance at p\u0026lt;0.05.\u003c/p\u003e"},{"header":"Results","content":"\u003cp\u003eA total of 21 participants were enrolled 10 assigned to the experimental group and 11 to the control group. Baseline demographics were comparable between groups. The experimental cohort had a mean age of 40.6\u0026thinsp;\u0026plusmn;\u0026thinsp;13.6 years (range 26 to 59), while the control cohort averaged 44.9\u0026thinsp;\u0026plusmn;\u0026thinsp;18.8 years (range 19 to 75). Men predominated in both groups, comprising 60.0 percent (6/10) of the experimental group and 63.6 percent (7/11) of the control group, with the remaining participants identifying as women.\u003c/p\u003e\u003cp\u003e\u003cdiv class=\"gridtable\"\u003e\u003ctable float=\"Yes\" id=\"Tab1\" border=\"1\"\u003e\u003ccaption language=\"En\"\u003e\u003cdiv class=\"CaptionNumber\"\u003eTable 1\u003c/div\u003e\u003cdiv class=\"CaptionContent\"\u003e\u003cp\u003e\u0026ndash; Age distribution of experimental group\u003c/p\u003e\u003c/div\u003e\u003c/caption\u003e\u003ccolgroup cols=\"3\"\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c1\" colnum=\"1\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c2\" colnum=\"2\"\u003e\u003c/div\u003e\u003cdiv align=\"left\" class=\"colspec\" colname=\"c3\" colnum=\"3\"\u003e\u003c/div\u003e\u003cthead\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eCharacteristic\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u003cp\u003eExperimental group (n\u0026thinsp;=\u0026thinsp;10)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u003cp\u003eControl group (n\u0026thinsp;=\u0026thinsp;11)\u003c/p\u003e\u003c/th\u003e\u003c/tr\u003e\u003ctr\u003e\u003cth align=\"left\" colname=\"c1\"\u003e\u003cp\u003eAge (years)\u003c/p\u003e\u003c/th\u003e\u003cth align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/th\u003e\u003cth align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/th\u003e\u003c/tr\u003e\u003c/thead\u003e\u003ctbody\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMean\u0026thinsp;\u0026plusmn;\u0026thinsp;SD\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e40.6\u0026thinsp;\u0026plusmn;\u0026thinsp;13.6\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e44.9\u0026thinsp;\u0026plusmn;\u0026thinsp;18.8\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eRange\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e26\u0026ndash;59\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e19\u0026ndash;75\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003e\u003cb\u003eGender, n (%)\u003c/b\u003e\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u0026nbsp;\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u0026nbsp;\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eMale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e6 (60.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e7 (63.6%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003ctr\u003e\u003ctd align=\"left\" colname=\"c1\"\u003e\u003cp\u003eFemale\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c2\"\u003e\u003cp\u003e4 (40.0%)\u003c/p\u003e\u003c/td\u003e\u003ctd align=\"left\" colname=\"c3\"\u003e\u003cp\u003e4 (36.4%)\u003c/p\u003e\u003c/td\u003e\u003c/tr\u003e\u003c/tbody\u003e\u003c/colgroup\u003e\u003c/table\u003e\u003c/div\u003e\u003c/p\u003e\u003cp\u003e\u003cem\u003eSD\u0026thinsp;=\u0026thinsp;standard deviation.\u003c/em\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eFeasibility results: see\u003c/b\u003e Table\u0026nbsp;\u003cspan refid=\"Tab2\" class=\"InternalRef\"\u003e2\u003c/span\u003e\u003c/p\u003e\n\u003ch3\u003e1)Recruitment Process\u003c/h3\u003e\n\u003cp\u003eOverall, fifty participants were contacted to participate the study, of which thirty participants were eligible for the study, further twenty-one patients completed the protocol, demonstrating intervention feasibility and adherence. The reasons for the dropout have been provided in the Fig.\u0026nbsp;\u003cspan refid=\"Fig4\" class=\"InternalRef\"\u003e1\u003c/span\u003e\u003c/p\u003e\u003cp\u003e\u003cb\u003eData Collection\u003c/b\u003e\u003c/p\u003e\u003cp\u003e\u003c/p\u003e\n\u003ch3\u003e2)Self-reported acceptability of random allocation into groups\u003c/h3\u003e\n\u003cp\u003eThe mean time to complete the screening procedure was about thirty (30) minutes including the initial screening and baseline assessment.\u003c/p\u003e\n\u003ch3\u003e3)Acceptability of interventions\u003c/h3\u003e\n\u003cp\u003eAll participants were able to accept the intervention at the end of one-week intervention, from both groups except few in the experimental group, expressed that \u0026ldquo;\u003cem\u003ewhile the concept/theory was interesting but while I was in severe pain, I had to take medications so some practical tips should be given to get relief from pain\u0026rdquo;\u003c/em\u003e\u003c/p\u003e\n\u003ch3\u003e4)Self-reported intervention adherence at the end of 2nd week\u003c/h3\u003e\n\u003cp\u003eAll participants in control and experimental group were able to adhere to the intervention.\u003c/p\u003e\n\u003ch3\u003e5)Perceived confidence in understanding of interventions at the end of 2nd week\u003c/h3\u003e\n\u003cp\u003eEach participant in the intervention group expressed that they were able to understand the concept very well, some of them appreciated that the information shared is very much relatable in their life circumstances and came forwarded to summarize the education program offered to them to ensure their understanding is correct, one person said that, after \u003cem\u003elistening to the education program and applied it made me to think that when I am in Pain, I should not panic, rather I need to calm down\u003c/em\u003e. Another person said that, when pain increases, \u003cem\u003eI need to say to myself that I am in good health, this pain is an over protective response of my brain, so I don\u0026rsquo;t have to worry.\u003c/em\u003e\u003c/p\u003e\n\u003ch3\u003e6) Self-reported Adverse Event\u003c/h3\u003e\n\u003cp\u003eNo adverse events reported from any group.\u003c/p\u003e\u003cp\u003e\u003cb\u003e7)Self-reported improvement at the end of 2nd week\u003c/b\u003e -Both groups Expressed improvement in pain reduction. But PSE group felt confident in returning to work and physical activity.\u003c/p\u003e\u003cp\u003e\u003cstrong\u003e8)Participant retention\u003c/strong\u003e\u003c/p\u003e\n\u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003eOut of the 12 participants started the interventions in each group, one from each group did not completed intervention due to personnel reason, hence they have withdrawn their consent to participate.\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e\u003cstrong\u003e9) Intervention delivery:\u003c/strong\u003e\u003c/p\u003e\n\u003col style=\"list-style-type: lower-alpha;\"\u003e\n \u003cli\u003eNumber of intervention sessions delivered -6 session each on alternative days for two weeks for both groups\u003c/li\u003e\n \u003cli\u003eNumber of intervention sessions cancelled/rescheduled with reasons-Nil\u003c/li\u003e\n \u003cli\u003eTime spent with participants during each intervention session-60 Minutes\u003c/li\u003e\n \u003cli\u003eTherapists\u0026rsquo; perceived usefulness of the intervention sessions \u0026ndash; 100%,\u003c/li\u003e\n \u003cli\u003eTherapists\u0026rsquo; perceived difficulty in delivering the interventions -10% skill training on light cognitive behaviour therapy, patient counselling would help the therapist to execute it better.\u003c/li\u003e\n \u003cli\u003eTherapists\u0026rsquo; feedback on the content of PSE delivered - Excellent\u003c/li\u003e\n\u003c/ol\u003e\n\u003cp\u003e10)Time taken to complete patient-reported questionnaires at the end of one week; 20 minutes\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eTable 2. Feasibility outcome results\u003c/strong\u003e\u003c/p\u003e\n\u003ctable border=\"1\" cellspacing=\"0\" cellpadding=\"0\" width=\"671\"\u003e\n \u003ctbody\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eSL\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eNo.\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 239px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eFeasibility outcomes\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eExperimental\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eN (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eControl\u003c/strong\u003e\u003c/p\u003e\n \u003cp\u003e\u003cstrong\u003eN (%)\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e\u003cstrong\u003ep-value\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e\u003cstrong\u003eResult\u003c/strong\u003e\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e1\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 239px;\"\u003e\n \u003cp\u003eRecruitment rate\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e12 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e12 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003eN/A\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e3 per month\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e2\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 239px;\"\u003e\n \u003cp\u003eRetention at twelve weeks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e11 of 12 (92)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e11 of 12 (92)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e87%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e3\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 239px;\"\u003e\n \u003cp\u003eAcceptability of random allocation\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e12 of 12 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e12 of 12 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e95 %\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\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: 239px;\"\u003e\n \u003cp\u003ea. Mean time to complete screening procedure\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e30 Minutes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e30 Minutes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003eIncluding the initial screening and baseline assessment\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e4\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 239px;\"\u003e\n \u003cp\u003eAcceptability of interventions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e10 of 12 (83)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e11 of 12 (92)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e95 %\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 239px;\"\u003e\n \u003cp\u003eIntervention adherence at two weeks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e10 of 10 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e11 of 11 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e100 %\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 239px;\"\u003e\n \u003cp\u003eConfidence in understanding interventions\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e10 of 10 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e11 of 11 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e100 %\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e7\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 239px;\"\u003e\n \u003cp\u003eAdverse events\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e0 of 12 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e0 of 12 (0)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003eCriteria met\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e8\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 239px;\"\u003e\n \u003cp\u003eSelf-reported improvement at two weeks\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e11 of 11 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e11 of 11 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e100 %\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\u003e\n \u003ctd valign=\"top\" style=\"width: 26px;\"\u003e\n \u003cp\u003e9\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 239px;\"\u003e\n \u003cp\u003eIntervention delivery fidelity\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e60 of 66 (91)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e66 of 66 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003eCriteria met\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\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: 239px;\"\u003e\n \u003cp\u003ea. \u0026nbsp;Number of intervention sessions delivered\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e60\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e66\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003esix sessions in two weeks for both groups\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\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: 239px;\"\u003e\n \u003cp\u003eb. Number of sessions cancelled or rescheduled\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e6\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e0\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003eCriteria met\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\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: 239px;\"\u003e\n \u003cp\u003ec. \u0026nbsp;Time spent per session\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e60 minutes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e60minutes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e60 minutes\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\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: 239px;\"\u003e\n \u003cp\u003ed. \u0026nbsp;Therapists perceived usefulness\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003eextremely useful\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\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: 26px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 239px;\"\u003e\n \u003cp\u003ee. Therapists perceived difficulty\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003esomewhat difficult\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e5/5-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\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: 26px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 239px;\"\u003e\n \u003cp\u003ef. Therapists feedback on content\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003eexcellent\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e5/5\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\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: 26px;\"\u003e\n \u003cp\u003e10\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 239px;\"\u003e\n \u003cp\u003eQuestionnaire completion rate\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e11 of 11 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e11 of 11 (100)\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e1.000\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e100%\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003ctr\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: 239px;\"\u003e\n \u003cp\u003ea. Time to complete questionnaires\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 116px;\"\u003e\n \u003cp\u003e20 minutes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 92px;\"\u003e\n \u003cp\u003e20 minutes\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 66px;\"\u003e\n \u003cp\u003e-\u003c/p\u003e\n \u003c/td\u003e\n \u003ctd valign=\"top\" style=\"width: 132px;\"\u003e\n \u003cp\u003e\u0026nbsp;\u003c/p\u003e\n \u003c/td\u003e\n \u003c/tr\u003e\n \u003c/tbody\u003e\n\u003c/table\u003e\n\u003cp\u003e\u003cstrong\u003eSecondary outcome results:\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eSignificant improvements in pain (NPRS) and functional disability (RMQ) were observed in both groups. The PSE group(N=10) exhibited superior outcomes I.e. NPRS scores decreased significantly from 6.00\u0026plusmn;2.49 to 4.40\u0026plusmn;2.31 (p=0.016), and RMQ scores from 12.00\u0026plusmn;5.69 to 10.00\u0026plusmn;4.97 (p=0.026). Comparatively, the control group improved from 5.73\u0026plusmn;1.67 to 4.55\u0026plusmn;1.36 (p=0.010) on NPRS and from 9.45\u0026plusmn;4.08 to 8.27\u0026plusmn;4.59 (p=0.016) on RMQ. Percentage improvements favoured the PSE group (27% pain, 17% disability) versus control (20% pain, 12% disability), highlighting the additional benefit of integrating Pain science education strategies with conventional physiotherapy. However, there was no significant difference observed between groups. Fig:2\u0026amp;3\u003c/p\u003e"},{"header":"Discussion","content":"\u003cp\u003eAfter successfully developing culturally adapted Pain Science Education (PSE) in Indian languages, this study serves as a critical second step by evaluating the feasibility, acceptability, and preliminary effectiveness of this intervention for reducing pain intensity and disability among patients with CLBP in India. Our culturally tailored approach notably enhanced patient comprehension and acceptance, aligning with global evidence advocating culturally sensitive educational interventions. This finding resonates with international research underscoring the importance of culturally contextualized education in chronic pain management.\u003csup\u003e[\u003cspan citationid=\"CR25\" class=\"CitationRef\"\u003e25\u003c/span\u003e]\u003c/sup\u003e\u003c/p\u003e\u003cp\u003eSimilar results have been documented in various geographic contexts, emphasizing the importance of cultural adaptations. For example, Sharma et al. \u003csup\u003e[\u003cspan citationid=\"CR26\" class=\"CitationRef\"\u003e26\u003c/span\u003e]\u003c/sup\u003ereported comparable outcomes in Nepal, demonstrating significant patient engagement and understanding following culturally adapted pain education. Our attrition rate was higher compared to Nepal study studies, they recorded a lower attrition rate, largely attributed to the single-session format.\u003c/p\u003e\u003cp\u003eMoreover, research from Spain provides additional comparative insights highlighted that patient receiving culturally adapted educational interventions exhibited improved adherence and satisfaction compared to generic educational content\u003csup\u003e[\u003cspan citationid=\"CR27\" class=\"CitationRef\"\u003e27\u003c/span\u003e]\u003c/sup\u003e. Similar to our findings, the Spanish study underscored the necessity of integrating culturally relevant examples and metaphors, but differences arose in patient adherence patterns, partly explained by differing cultural expectations around healthcare interactions. Unlike the single-session delivery utilized in Nepal, multiple sessions in the Spanish context allowed gradual patient assimilation of information, echoing our methodology. This suggests that structured multiple-session formats, despite increased risk of attrition, may offer cumulative educational benefits and facilitate behavioural changes.\u003c/p\u003e\u003cp\u003eAn essential insight from our study pertains to participant adherence and the implications for attrition. We noted that improved patient condition occasionally resulted in early withdrawal, a phenomenon also observed internationally \u003csup\u003e[\u003cspan citationid=\"CR28\" class=\"CitationRef\"\u003e28\u003c/span\u003e]\u003c/sup\u003e This behaviour underscores the necessity of patient education about maintaining consistent intervention schedules, even when symptomatic relief occurs prematurely, ensuring sustained long-term benefits.\u003c/p\u003e\u003cp\u003eAddressing feasibility specifically, our study demonstrated an adequate recruitment rate and high retention, meeting a post-hoc criterion of at least 85%. Nonetheless, further efforts to broaden recruitment outreach could bolster future studies, particularly considering diverse regional settings within India. Retention strategies employed internationally, such as regular follow-up reminders or digital engagement tools (e.g., mobile applications), might further enhance participant retention.\u003c/p\u003e\u003cp\u003eThe methodological rigor employed herein underscores strong acceptance across varied educational backgrounds among participants, substantiating the adaptability of PSE as a standard care intervention for Indian CLBP populations. However, feedback indicating a demand for more practical pain-management tips necessitates augmenting future interventions with concrete self-management strategies and practical cognitive-behavioural techniques. Such enhancements would not only align with global multidisciplinary pain management recommendations but also potentially elevate patient satisfaction and adherence.\u003c/p\u003e\u003cp\u003eFurthermore, our findings highlight the therapist\u0026rsquo;s role and required attributes for effective intervention delivery. Therapists underscored the importance of empathy, compassion, patient-centric listening skills, and basic counselling competencies, reinforcing international recommendations for therapist training \u003csup\u003e[\u003cspan citationid=\"CR29\" class=\"CitationRef\"\u003e29\u003c/span\u003e]\u003c/sup\u003e These qualitative insights are valuable for refining future training curricula and optimizing therapist preparedness, subsequently enhancing patient-therapist interactions and overall therapeutic outcomes.\u003c/p\u003e\u003cp\u003eA distinctive aspect of this study involves the integration of self-management components such as positive affirmations and cognitive reorientation, aligning closely with global trends advocating comprehensive biopsychosocial management frameworks. For instance, international guidelines such as those from the International Association for the Study of Pain (IASP) and NICE consistently emphasize psychological factors and cognitive strategies as core components of chronic pain management \u003csup\u003e[\u003cspan citationid=\"CR30\" class=\"CitationRef\"\u003e30\u003c/span\u003e]\u003c/sup\u003e ,By incorporating these elements into physiotherapeutic practice, our study uniquely contributes to evidence supporting holistic and integrative chronic pain care models.\u003c/p\u003e\u003cp\u003eDespite encouraging preliminary outcomes, several limitations warrant acknowledgment. Our relatively small sample size, inherent to feasibility studies, restricts generalizability. Additionally, longer-term follow-up periods extending beyond two weeks are crucial to assess sustained intervention impacts fully. Future large-scale randomized controlled trials with extended follow-up intervals are essential to validate these promising preliminary results conclusively and could significantly influence both clinical practice and national chronic pain management guidelines in India.\u003c/p\u003e\u003cp\u003eThis feasibility study demonstrates the promising potential of culturally adapted PSE interventions in the Indian context, supporting their acceptability, comprehension, and initial effectiveness. Comparison with international studies highlights both shared challenges and unique cultural distinctions, underscoring the necessity for continued culturally sensitive adaptations. Future research should prioritize integrating practical behavioural strategies and sustained cognitive-behavioural support, ultimately aiming to enhance long-term patient outcomes and adherence.\u003c/p\u003e\u003cp\u003e\u003cb\u003eStrengths of the study\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThis is the first feasibility RCT study on PSE for CLBP conducted in India, Considering India has a diverse cultural, socio-economic and educational background, education as a primary intervention has been attempted and found it\u0026rsquo;s well accepted, hence a full scale RCT can be conducted to test its efficacy. This study has also revealed the expectations of patients in terms of a need for a practical tip as a part of pain science education is a unique addendum. Similarly, as per the therapist\u0026rsquo;s feedback/observation, enabling the patient to ventilate their life stress by being an active listener and express empathy towards the patient to be worth noted and incorporated in the future studies.\u003c/p\u003e\u003cp\u003e\u003cb\u003eLimitation of the study\u003c/b\u003e\u003c/p\u003e\u003cp\u003eThe results of the secondary outcome measures cannot be weighted as the sample size is small.\u003c/p\u003e"},{"header":"Conclusion","content":"\u003cp\u003eThe Feasibility RCT trial demonstrates that culturally adapted Pain Science Education (PSE) is well received and showed a preliminary effect in reducing pain and disability among Indian patients with chronic low back pain. Larger-scale studies are warranted to confirm these findings and facilitate integration into clinical practice guidelines.\u003c/p\u003e"},{"header":"Abbreviations","content":"\u003cp\u003eCBT \u0026ndash; Cognitive Behavioural Therapy\u2028\u003c/p\u003e\n\u003cp\u003eCLBP \u0026ndash; Chronic Low Back Pain\u0026nbsp;\u2028\u003c/p\u003e\n\u003cp\u003eCONSORT \u0026ndash; Consolidated Standards of Reporting Trials\u2028\u003c/p\u003e\n\u003cp\u003eCPG \u0026ndash; Clinical Practice Guideline\u2028\u003c/p\u003e\n\u003cp\u003eCTRI \u0026ndash; Clinical Trials Registry\u0026ndash;India\u2028\u003c/p\u003e\n\u003cp\u003eIEC \u0026ndash; Institutional Ethics Committee\u0026nbsp;\u2028\u003c/p\u003e\n\u003cp\u003eIQR \u0026ndash; Interquartile Range\u0026nbsp;\u2028\u003c/p\u003e\n\u003cp\u003eLBP \u0026ndash; Low Back Pain\u0026nbsp;\u2028NIMHANS \u0026ndash; National Institute of Mental Health \u0026amp; Neurosciences\u0026nbsp;\u2028NPRS \u0026ndash; Numeric Pain Rating Scale\u0026nbsp;\u2028\u003c/p\u003e\n\u003cp\u003ePSE \u0026ndash; Pain Science Education\u0026nbsp;\u2028\u003c/p\u003e\n\u003cp\u003eRCT \u0026ndash; Randomized Controlled Trial\u0026nbsp;\u2028\u003c/p\u003e\n\u003cp\u003eRMQ \u0026ndash; Roland-Morris Disability Questionnaire\u0026nbsp;\u2028\u003c/p\u003e\n\u003cp\u003eRDI \u0026ndash; Roland Disability Index (alternative name for RMQ)\u0026nbsp;\u2028\u003c/p\u003e\n\u003cp\u003eRAG \u0026ndash; Red\u0026ndash;Amber\u0026ndash;Green feasibility status rating\u0026nbsp;\u003c/p\u003e\n\u003cp\u003eSD \u0026ndash; Standard Deviation\u0026nbsp;\u2028\u003c/p\u003e\n\u003cp\u003eSGIOT \u0026ndash; Sanjay Gandhi Institute of Orthopaedics \u0026amp; Traumatology\u0026nbsp;\u2028\u003c/p\u003e\n\u003cp\u003eSTarT \u0026ndash; Keele STarT Back Screening Tool\u0026nbsp;\u2028\u003c/p\u003e\n\u003cp\u003eWHO \u0026ndash; World Health Organization\u0026nbsp;\u2028\u003c/p\u003e\n\u003cp\u003eYLDs \u0026ndash; Years Lived with Disability\u003c/p\u003e"},{"header":"Declarations","content":"\u003cp\u003e\u003cstrong\u003eEthical Considerations\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eAll procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Declaration of Helsinki and its later amendments or comparable ethical standards. The study protocol was approved by the Institutional Ethics Committee of NIMHANS. Written informed consent was obtained from all participants.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAvailability of data and materials\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe de‑identified datasets generated and analyzed during the current study are available from the corresponding author on reasonable request.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eCompeting interests\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors declare that they have no competing interests.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eFunding\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThis research received no specific grant from any funding agency in the public, commercial or not‑for‑profit sectors.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConsent for publication\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eNot applicable. The manuscript does not contain any individual person\u0026rsquo;s identifiable data in any form.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAuthors\u0026rsquo; contributions\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eVSG conceived the study and secured ethics approval. VSG and CS designed the protocol. PV and VSG administered the interventions and collected data. MP managed data entry and performed the statistical analysis. VSG \u0026amp; MS drafted the manuscript. NP and MP critically revised the manuscript for important intellectual content. All authors read and approved the final manuscript.\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eAcknowledgements\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003eThe authors thank Dr Vasanthan R (Oxford College of Physiotherapy), Dr P Antony Leo Aseer (Sri Ramachandra Institute of Higher Education and Research), Dr Pradnya Dhargave, Dr Dhaval Shukla, and the physiotherapy interns at NIMHANS for their valuable assistance during the study.\u003c/p\u003e"},{"header":"References","content":"\u003col\u003e\u003cli\u003e\u003cspan\u003eGBD 2021 Low Back Pain Collaborators. Global, regional, and national burden of low back pain, 1990\u0026ndash;2020, its attributable risk factors, and projections to 2050: a systematic analysis of the Global Burden of Disease Study 2021. Lancet Rheumatol. 2023;5(6):e316-e329. Published 2023 May 22. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/S2665-9913(23)00098-X\u003c/span\u003e\u003cspan address=\"10.1016/S2665-9913(23)00098-X\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSaxena AK, Jain PN, Bhatnagar S. The Prevalence of Chronic Pain among Adults in India. Indian J Palliat Care. 2018;24(4):472\u0026ndash;7. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.4103/IJPC.IJPC_141_18\u003c/span\u003e\u003cspan address=\"10.4103/IJPC.IJPC_141_18\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGe L, Pereira MJ, Yap CW, Heng BH. Chronic low back pain and its impact on physical function, mental health, and health-related quality of life: a cross-sectional study in Singapore. Sci Rep. 2022;12(1):20040. Published 2022 Nov 21. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1038/s41598-022-24703-7\u003c/span\u003e\u003cspan address=\"10.1038/s41598-022-24703-7\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLatremoliere A, Woolf CJ. Central sensitization: a generator of pain hypersensitivity by central neural plasticity. J Pain. 2009;10(9):895\u0026ndash;926. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.jpain.2009.06.012\u003c/span\u003e\u003cspan address=\"10.1016/j.jpain.2009.06.012\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMeints SM, Edwards RR. Evaluating psychosocial contributions to chronic pain outcomes. Prog Neuropsychopharmacol Biol Psychiatry. 2018;87(Pt B):168\u0026ndash;82. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.pnpbp.2018.01.017\u003c/span\u003e\u003cspan address=\"10.1016/j.pnpbp.2018.01.017\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eScholz J, Woolf CJ. Can we conquer pain? Nat Neurosci. 2002;5:1062\u0026ndash;7. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1038/nn942\u003c/span\u003e\u003cspan address=\"10.1038/nn942\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eDe Ridder D, Adhia D, Vanneste S. The anatomy of pain and suffering in the brain and its clinical implications. Neurosci Biobehav Rev. 2021;130:125\u0026ndash;46. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.neubiorev.2021.08.013\u003c/span\u003e\u003cspan address=\"10.1016/j.neubiorev.2021.08.013\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLarsson C, Ekvall Hansson E, Sundquist K, Jakobsson U. Impact of pain characteristics and fear-avoidance beliefs on physical activity levels among older adults with chronic pain: a population-based, longitudinal study. BMC Geriatr. 2016;16:50. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1186/s12877-016-0224-3\u003c/span\u003e\u003cspan address=\"10.1186/s12877-016-0224-3\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Published 2016 Feb 24.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBonfim IDS, Corr\u0026ecirc;a LA, Nogueira LAC, Meziat-Filho N, Reis FJJ, de Almeida RS. Your spine is so worn out' - the influence of clinical diagnosis on beliefs in patients with non-specific chronic low back pain - a qualitative study. Braz J Phys Ther. 2021;25(6):811\u0026ndash;8. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.bjpt.2021.07.001\u003c/span\u003e\u003cspan address=\"10.1016/j.bjpt.2021.07.001\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHaldeman S, Dagenais S. A supermarket approach to the evidence-informed management of chronic low back pain. Spine J. 2008;8(1):1\u0026ndash;7. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.spinee.2007.10.009\u003c/span\u003e\u003cspan address=\"10.1016/j.spinee.2007.10.009\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eJiang H, Zhang X, Liang J. The Combined Effect Between Sleep Disorders and Depression Symptoms on Chronic Low Back Pain: A Cross-Sectional Study of NHANES. J Pain Res. 2024;17:2777\u0026ndash;87. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2147/JPR.S471401\u003c/span\u003e\u003cspan address=\"10.2147/JPR.S471401\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Published 2024 Aug 26.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eFalling C, Stebbings S, Baxter GD, et al. Symptoms of central sensitization in patients with inflammatory bowel diseases: a case-control study examining the role of musculoskeletal pain and psychological factors. Scand J Pain. 2020;21(2):283\u0026ndash;95. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1515/sjpain-2020-0109\u003c/span\u003e\u003cspan address=\"10.1515/sjpain-2020-0109\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Published 2020 Oct 28.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBeissner K, Henderson CR Jr, Papaleontiou M, Olkhovskaya Y, Wigglesworth J, Reid MC. Physical therapists\u0026rsquo; use of cognitive-behavioral therapy for older adults with chronic pain: a nationwide survey. Phys Ther. 2009;89(5):456\u0026ndash;69. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.2522/ptj.20080163\u003c/span\u003e\u003cspan address=\"10.2522/ptj.20080163\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003epubmed.ncbi.nlm.nih.gov\u003c/span\u003e\u003cspan address=\"http://pubmed.ncbi.nlm.nih.gov\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNijs J, Clark J, Malfliet A, et al. In the spine or in the brain? Recent advances in pain neuroscience applied in the intervention for low back pain. Clin Exp Rheumatol. 2017;35(Suppl 107):108\u0026ndash;15.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003e\u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003ehttps://www.who.int/publications/i/item/9789240081789\u003c/span\u003e\u003cspan address=\"https://www.who.int/publications/i/item/9789240081789\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eGanesh GS, Khan AR, Khan A. Factors contributing to non-compliance with active physiotherapy guidelines among chronic low back pain patients in India. Arch Physiother. 2024;14:155\u0026ndash;69. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.33393/aop.2024.3217\u003c/span\u003e\u003cspan address=\"10.33393/aop.2024.3217\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. PMID: 39777288; PMCID: PMC11704684.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eWatson JA, Ryan CG, Cooper L, et al. Pain Neuroscience Education for Adults With Chronic Musculoskeletal Pain: A Mixed-Methods Systematic Review and Meta-Analysis. J Pain. 2019;20(10):1140. .e1-1140.e22.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLouw A, Diener I, Butler DS, Puentedura EJ. The effect of neuroscience education on pain, disability, anxiety, and stress in chronic musculoskeletal pain. Arch Phys Med Rehabil. 2011;92(12):2041\u0026ndash;56. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.apmr.2011.07.198\u003c/span\u003e\u003cspan address=\"10.1016/j.apmr.2011.07.198\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eLouw A, Puentedura EJ, Diener I, Zimney KJ, Cox T. Pain neuroscience education: Which pain neuroscience education metaphor worked best? S Afr J Physiother. 2019;75(1):1329. Published 2019 Aug 13. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.4102/sajp.v75i1.1329\u003c/span\u003e\u003cspan address=\"10.4102/sajp.v75i1.1329\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSharma S, Jensen MP, Moseley GL, et al. Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial. BMJ Open. 2019;9(3):e026874. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1136/bmjopen-2018-026874\u003c/span\u003e\u003cspan address=\"10.1136/bmjopen-2018-026874\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eMukhtar NB, Meeus M, Gursen C, et al. Development of culturally sensitive pain neuroscience education materials for Hausa-speaking patients with chronic spinal pain: A modified Delphi study. PLoS ONE. 2021;16(7):e0253757. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1371/journal.pone.0253757\u003c/span\u003e\u003cspan address=\"10.1371/journal.pone.0253757\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eOrhan C, Cagnie B, Favoreel A, et al. Development of culturally sensitive Pain Neuroscience Education for first-generation Turkish patients with chronic pain: a modified Delphi study. Musculoskelet Sci Pract. 2019;39:1\u0026ndash;9. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1016/j.msksp.2018.10.007\u003c/span\u003e\u003cspan address=\"10.1016/j.msksp.2018.10.007\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSelva Ganapathy V, Desai G, Krishnamurthy L, Manjula M, Banu MR, Sharma S. (2025). Development of pain science education for chronic low back pain in India. J Man Manipulative Therapy, 1\u0026ndash;7.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eAbbott JH. The distinction between randomized clinical trials (RCTs) and preliminary feasibility and pilot studies: what they are and are not. J Orthop Sports Phys Ther. 2014;44:555\u0026ndash;8.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eCipta DA, Andoko D, Theja A, et al. Culturally sensitive patient-centered healthcare: a focus on health behavior modification in low and middle-income nations-insights from Indonesia. Front Med (Lausanne). 2024;11:1353037. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3389/fmed.2024.1353037\u003c/span\u003e\u003cspan address=\"10.3389/fmed.2024.1353037\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. Published 2024 Apr 12.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eSharma S, Jensen MP, Moseley GL, et al. Results of a feasibility randomised clinical trial on pain education for low back pain in Nepal: the Pain Education in Nepal-Low Back Pain (PEN-LBP) feasibility trial. BMJ Open. 2019;9(3):e026874. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1136/bmjopen-2018-026874\u003c/span\u003e\u003cspan address=\"10.1136/bmjopen-2018-026874\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eNavarro-Braz\u0026aacute;lez B, Vergara-P\u0026eacute;rez F, Prieto-G\u0026oacute;mez V, S\u0026aacute;nchez-S\u0026aacute;nchez B, Yuste-S\u0026aacute;nchez MJ, Torres-Lacomba M. What influences women to adhere to pelvic floor exercises after physiotherapy treatment? A qualitative study for individualized pelvic health care. J Pers Med. 2021;11(12):1368. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.3390/jpm11121368\u003c/span\u003e\u003cspan address=\"10.3390/jpm11121368\" targettype=\"DOI\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003epmc.ncbi.nlm.nih.gov\u003c/span\u003e\u003cspan address=\"http://pmc.ncbi.nlm.nih.gov\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eBeeckman M, Hughes S, Van der Kaap-Deeder J, Plasschaert F, Michielsen J, Moens P, et al. Risk and resilience predictors of recovery after spinal fusion surgery in adolescents. Clin J Pain. 2021;37(11):789\u0026ndash;802. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003epubmed.ncbi.nlm.nih.gov\u003c/span\u003e\u003cspan address=\"http://pubmed.ncbi.nlm.nih.gov\" targettype=\"URL\" class=\"RefTarget\"\u003e\u003c/span\u003e\u003c/span\u003e.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eHutson H, Louw A, Puentedura EJ, Zimney K. Therapist empathy, compassion and patient-centred communication skills for delivering pain neuroscience education: a Delphi consensus study. Musculoskelet Sci Pract. 2019;42:51\u0026ndash;9.\u003c/span\u003e\u003c/li\u003e\u003cli\u003e\u003cspan\u003eRaja SN, Carr DB, Cohen M, et al. The revised International Association for the Study of Pain definition of pain: concepts, challenges, and compromises. Pain. 2020;161(9):1976\u0026ndash;82. \u003cspan class=\"ExternalRef\"\u003e\u003cspan class=\"RefSource\"\u003e10.1097/j.pain.0000000000001939\u003c/span\u003e\u003cspan address=\"10.1097/j.pain.0000000000001939\" 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":false,"highlight":"","institution":"","isAcceptedByJournal":false,"isAuthorSuppliedPdf":false,"isDeskRejected":"","isHiddenFromSearch":false,"isInQc":false,"isInWorkflow":false,"isPdf":false,"isPdfUpToDate":true,"isWithdrawnOrRetracted":false,"journal":{"display":true,"email":"[email protected]","identity":"bmc-musculoskeletal-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmsd","sideBox":"Learn more about [BMC Musculoskeletal Disorders](http://bmcmusculoskeletdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://author-welcome.nature.com/12891","title":"BMC Musculoskeletal Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true},"keywords":"Chronic Low back Pain (CLBP), Pain Science Education (PSE), Central Hypersensitivity, kinesiophobia \u0026 Cognitive distortion","lastPublishedDoi":"10.21203/rs.3.rs-7129655/v1","lastPublishedDoiUrl":"https://doi.org/10.21203/rs.3.rs-7129655/v1","license":{"name":"CC BY 4.0","url":"https://creativecommons.org/licenses/by/4.0/"},"manuscriptAbstract":"\u003cp\u003e\u003cstrong\u003eBackground\u003c/strong\u003e: Chronic Low back pain (CLBP) is highly prevalent and results in socioeconomic burden to an individual and to the government as there is an increased health care cost. As the pathology of CLBP is confined with hyper sensitivity of central nervous system leads to produce amplified pain response for a relatively suboptimal stimulus. The characteristic attitude of overprotection by an individual with low back pain (LBP) too contribute towards the mechanism of central hypersensitivity. Pain Science Education (PSE) along with graded exposure of physical activity and exercise are consider to be an effective intervention for CLBP. However, the content of PSE needs to be translated and culturally validated to suit to the local population. In India, for the first time such work has been completed, but feasibility to conduct a Randomized Controlled trial using the newly developed PSE education has not been completed. This study has been planned to fill the gap in research.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eMethodology\u003c/strong\u003e: It’s an assessor-blinded feasibility randomized controlled trial (RCT),which included patients with CLBP with the duration of more than three months from the age group above 18 years and patients with additional comorbidity such as Severe psychiatric conditions (e.g., severe depression, schizophrenia)acute medical conditions preventing physical activity, neurological deficits or cognitive impairments, recent surgery or trauma affecting the back (within six months),Pregnancy or postpartum within six months. Patients were randomly allotted to the either control group or experimental group., Control group received guideline based physiotherapy which includes assurance, patient education, back and core muscle exercise, walking for 30 minutes, the experimental group received Culturally validated Pain Science Education(PSE) for an hour and advised to recollect the points and to undergo thirty minutes of walking every day for about 30 minutes, the feasibility criteria which includes Recruitment rate,acceptability,adherence to intervention etc. Two secondary outcome measures were also applied namely, Numerical Pain Rating Scale and Rolland Morris Disability Index on day one and day seven.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eResults\u003c/strong\u003e: This study has met the preset Recruitment rate of 80%, Acceptability by patients of about 75% and the adherence rate of 90%, also there was a preliminary effect of culturally developed PSE was found.\u003cstrong\u003e\u0026nbsp;\u003c/strong\u003e\u003c/p\u003e\n\u003cp\u003e\u003cstrong\u003eConclusion\u003c/strong\u003e: In India, feasibility of pain science education (PSE) as an intervention for CLBP has been established and a preliminary result are in favor of PSE group, hence it may be considered as a main stream treatment utilizing the available resource developed. A definite trial to prove the efficacy of PSE in CLBP is warranted. Trial registration: Clinical Trials Registry India (CTRI), CTRI/2022/07/044069; prospectively registered on 15 July 2022.\u003c/p\u003e","manuscriptTitle":"Culturally Adapted Pain Science Education (PSE) for Chronic Low Back Pain in India: A feasibility Randomized Controlled Trial","msid":"","msnumber":"","nonDraftVersions":[{"code":1,"date":"2025-09-01 08:51:54","doi":"10.21203/rs.3.rs-7129655/v1","editorialEvents":[{"type":"communityComments","content":0},{"type":"editorInvitedReview","content":"","date":"2025-08-27T14:35:10+00:00","index":"hide","fulltext":""},{"type":"editorInvitedReview","content":"","date":"2025-08-20T11:45:08+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"330165619615054806750777392693688672209","date":"2025-08-19T14:01:19+00:00","index":"hide","fulltext":""},{"type":"reviewerAgreed","content":"168718732039295845408795039411555653236","date":"2025-08-19T13:01:34+00:00","index":"hide","fulltext":""},{"type":"reviewersInvited","content":"","date":"2025-08-19T12:33:30+00:00","index":"","fulltext":""},{"type":"editorInvited","content":"","date":"2025-08-12T10:54:30+00:00","index":"","fulltext":""},{"type":"editorAssigned","content":"","date":"2025-07-21T10:35:04+00:00","index":"","fulltext":""},{"type":"checksComplete","content":"","date":"2025-07-21T10:31:40+00:00","index":"","fulltext":""},{"type":"submitted","content":"BMC Musculoskeletal Disorders","date":"2025-07-21T09:57:51+00:00","index":"","fulltext":""}],"status":"published","journal":{"display":true,"email":"[email protected]","identity":"bmc-musculoskeletal-disorders","isNatureJournal":false,"hasQc":true,"allowDirectSubmit":false,"externalIdentity":"bmsd","sideBox":"Learn more about [BMC Musculoskeletal Disorders](http://bmcmusculoskeletdisord.biomedcentral.com/)","snPcode":"","submissionUrl":"https://author-welcome.nature.com/12891","title":"BMC Musculoskeletal Disorders","twitterHandle":"BMC_series","acdcEnabled":true,"dfaEnabled":true,"editorialSystem":"stoa","reportingPortfolio":"BMC Series","inReviewEnabled":true,"inReviewRevisionsEnabled":true}}],"origin":"","ownerIdentity":"30b11a66-9023-4e18-9764-61c06a483509","owner":[],"postedDate":"September 1st, 2025","published":true,"recentEditorialEvents":[],"rejectedJournal":[],"revision":"","amendment":"","status":"under-review","subjectAreas":[],"tags":[],"updatedAt":"2025-09-01T08:51:54+00:00","versionOfRecord":[],"versionCreatedAt":"2025-09-01 08:51:54","video":"","vorDoi":"","vorDoiUrl":"","workflowStages":[]},"version":"v1","identity":"rs-7129655","journalConfig":"researchsquare"},"__N_SSP":true},"page":"/article/[identity]/[[...version]]","query":{"redirect":"/article/rs-7129655","identity":"rs-7129655","version":["v1"]},"buildId":"8U1c8b4HqxoKbykW_rLl7","isFallback":false,"isExperimentalCompile":false,"dynamicIds":[84888],"gssp":true,"scriptLoader":[]}