Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial

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M. Amran Hossain" }, { "@type": "Person", "name": "Md. Sohrab Hossain" }, { "@type": "Person", "name": "Rashida Parvin" }, { "@type": "Person", "name": "Nadia Afrin Urme" }, { "@type": "Person", "name": "Veena Raigangar" }, { "@type": "Person", "name": "Iqbal Kabir Jahid" }, { "@type": "Person", "name": "Md. Feroz Kabir" }, { "@type": "Person", "name": "Md. Ashrafuzzaman Zahid" } ], "publisher": { "@type": "Organization", "name": "F1000Research", "logo": { "@type": "ImageObject", "url": "https://f1000research.com/img/AMP/F1000Research_image.png", "height": 480, "width": 60 } }, "image": { "@type": "ImageObject", "url": "https://f1000research.com/img/AMP/F1000Research_image.png", "height": 1200, "width": 150 }, "description": " Background: Chronic low back pain (CLBP) is a common musculoskeletal disorder that significantly impairs quality of life and is frequently associated with vitamin D deficiency. Therapeutic exercise is a cornerstone of management, yet the optimal adjunct intervention to restore serum vitamin D levels remains uncertain. No prior randomized trial has compared oral vitamin D supplementation with lifestyle education on sun exposure, nutrition, and physical activity, both combined with therapeutic exercise. We hypothesize that therapeutic exercise plus an education booklet (TEB) may be superior to therapeutic exercise plus oral vitamin D supplementation (TED) in reducing pain and disability while improving serum vitamin D levels. Methods: This assessor-blinded, two-arm, multicenter randomized controlled trial (RCT) will be conducted in hospitals and rehabilitation centers in Dhaka city, Bangladesh. Adult participants (18–65 years) with CLBP and confirmed vitamin D deficiency will be recruited and randomized to either TEB or TED groups. Both groups will receive standardized therapeutic exercise protocols. The intervention duration will be 6 months, with assessments at baseline, 2 months, and 6 months. Primary outcomes include pain intensity measured by the Brief Pain Inventory (BPI) and serum 25(OH)D3 levels. Secondary outcomes include disability assessed by the Roland-Morris Disability Questionnaire (RMDQ). Statistical analysis will follow the intention-to-treat principle, using repeated measures ANOVA to compare group differences over time. Discussion: This trial will provide evidence on whether a multidimensional lifestyle-based education approach combined with therapeutic exercise offers greater benefit than vitamin D supplementation with exercise in CLBP patients with vitamin D deficiency. The findings will inform clinical guidelines and support comprehensive management strategies for CLBP, particularly in resource-limited settings. Registration: Clinical Trials Registry India (CTRI/2022/11/047074)." } { "@context": "http://schema.org", "@type": "BreadcrumbList", "itemListElement": [ { "@type": "ListItem", "position": "1", "item": { "@id": "https://f1000research.com/", "name": "Home" } }, { "@type": "ListItem", "position": "2", "item": { "@id": "https://f1000research.com/browse/articles", "name": "Browse" } }, { "@type": "ListItem", "position": "3", "item": { "@id": "https://f1000research.com/articles/11-1352/v2", "name": "Comparison of the effects of therapeutic exercise with either an educational..." } } ] } Home Browse Comparison of the effects of therapeutic exercise with either an educational... ALL Metrics - Views Downloads Get PDF Get XML Cite How to cite this article Islam MS, Hossain KMA, Hossain MS et al. Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.12688/f1000research.127948.2 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. Close Copy Citation Details Export Export Citation Sciwheel EndNote Ref. Manager Bibtex ProCite Sente EXPORT Select a format first Track Share ▬ ✚ Study Protocol Revised Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] Muhammad Shahidul Islam 1 , K. M. Amran Hossain https://orcid.org/0000-0003-2124-2087 2 , Md. Sohrab Hossain 3 , [...] Rashida Parvin 1 , Nadia Afrin Urme https://orcid.org/0000-0003-2618-4461 3 , Veena Raigangar 4 , Iqbal Kabir Jahid 5 , Md. Feroz Kabir https://orcid.org/0000-0002-5885-4514 2 , Md. Ashrafuzzaman Zahid 1 Muhammad Shahidul Islam 1 , K. M. Amran Hossain https://orcid.org/0000-0003-2124-2087 2 , [...] Md. Sohrab Hossain 3 , Rashida Parvin 1 , Nadia Afrin Urme https://orcid.org/0000-0003-2618-4461 3 , Veena Raigangar 4 , Iqbal Kabir Jahid 5 , Md. Feroz Kabir https://orcid.org/0000-0002-5885-4514 2 , Md. Ashrafuzzaman Zahid 1 PUBLISHED 03 Mar 2026 Author details Author details 1 Department of Nutrition & Food Technology, Jashore University of Science & Technology, Jashore, 7408, Bangladesh 2 Department of Physiotherapy & Rehabilitation, Jashore University of Science & Technology, Jashore, 7408, Bangladesh 3 Department of Physiotherapy, Bangladesh Health Professions Institute, Savar, 1343, Bangladesh 4 Department of Physiotherapy, School of Sport and Health Sciences, University of Brighton, Brighton, UK 5 Department of Microbiology, Jashore University of Science & Technology, Jashore, 7408, Bangladesh Muhammad Shahidul Islam Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Validation, Writing – Original Draft Preparation, Writing – Review & Editing K. M. Amran Hossain Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Methodology, Resources, Software, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Md. Sohrab Hossain Roles: Conceptualization, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Writing – Review & Editing Rashida Parvin Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Software, Validation, Visualization, Writing – Review & Editing Nadia Afrin Urme Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Resources, Software, Validation, Visualization, Writing – Review & Editing Veena Raigangar Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Resources, Software, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Iqbal Kabir Jahid Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Writing – Review & Editing Md. Feroz Kabir Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Validation, Visualization, Writing – Review & Editing Md. Ashrafuzzaman Zahid Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing OPEN PEER REVIEW DETAILS REVIEWER STATUS Abstract Background : Chronic low back pain (CLBP) is a common musculoskeletal disorder that significantly impairs quality of life and is frequently associated with vitamin D deficiency. Therapeutic exercise is a cornerstone of management, yet the optimal adjunct intervention to restore serum vitamin D levels remains uncertain. No prior randomized trial has compared oral vitamin D supplementation with lifestyle education on sun exposure, nutrition, and physical activity, both combined with therapeutic exercise. We hypothesize that therapeutic exercise plus an education booklet (TEB) may be superior to therapeutic exercise plus oral vitamin D supplementation (TED) in reducing pain and disability while improving serum vitamin D levels. Methods : This assessor-blinded, two-arm, multicenter randomized controlled trial (RCT) will be conducted in hospitals and rehabilitation centers in Dhaka city, Bangladesh. Adult participants (18–65 years) with CLBP and confirmed vitamin D deficiency will be recruited and randomized to either TEB or TED groups. Both groups will receive standardized therapeutic exercise protocols. The intervention duration will be 6 months, with assessments at baseline, 2 months, and 6 months. Primary outcomes include pain intensity measured by the Brief Pain Inventory (BPI) and serum 25(OH)D3 levels. Secondary outcomes include disability assessed by the Roland-Morris Disability Questionnaire (RMDQ). Statistical analysis will follow the intention-to-treat principle, using repeated measures ANOVA to compare group differences over time. Discussion : This trial will provide evidence on whether a multidimensional lifestyle-based education approach combined with therapeutic exercise offers greater benefit than vitamin D supplementation with exercise in CLBP patients with vitamin D deficiency. The findings will inform clinical guidelines and support comprehensive management strategies for CLBP, particularly in resource-limited settings. Registration: Clinical Trials Registry India ( CTRI/2022/11/047074 ). READ ALL READ LESS Keywords Chronic Low Back Pain, Therapeutic exercise, Vitamin-D3 supplement, Booklet Corresponding Author(s) Md. Ashrafuzzaman Zahid ( [email protected] ) Close Corresponding author: Md. Ashrafuzzaman Zahid Competing interests: No competing interests were disclosed. Grant information: The author(s) declared that no grants were involved in supporting this work. Copyright: © 2026 Islam MS et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. How to cite: Islam MS, Hossain KMA, Hossain MS et al. Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.12688/f1000research.127948.2 ) First published: 21 Nov 2022, 11 :1352 ( https://doi.org/10.12688/f1000research.127948.1 ) Latest published: 03 Mar 2026, 11 :1352 ( https://doi.org/10.12688/f1000research.127948.2 ) Revised Amendments from Version 1 Amendments from Version 1 The revised version of the manuscript incorporates the corrections and suggestions provided by the reviewers. Several substantive and editorial improvements have been made to enhance clarity, methodological rigor, and compliance with journal requirements. Study Design Clarification: We explicitly clarified that the trial is prospective, with baseline, post‑intervention, and follow‑up data collection. Eligibility Criteria: The inclusion and exclusion criteria were rewritten to specify the types of chronic low back pain considered and the conditions excluded, ensuring greater transparency. Methodological Details: Expanded descriptions were added regarding participant selection, randomization, allocation, blinding procedures, exercise protocol, booklet contents, and outcome measures, including their reliability and validity. Abstract and Keywords: The abstract was thoroughly revised to state the study objective, duration, setting, participant characteristics, treatment procedures, outcome measures, and statistical tests. Keywords were replaced with appropriate MeSH terms. Editorial Compliance: The manuscript was reformatted to meet journal requirements, including word limits, number of keywords, and citation style. Discussion Enhancements: The discussion now emphasizes the rehabilitative implications of the study, highlighting how therapeutic exercise may influence vitamin D metabolism and functional recovery, while lifestyle education could support self‑regulation of vitamin D3 levels. Comparative Context: Differences between our study and Reference 10 were clarified, underscoring the novelty of our randomized, assessor‑blinded multicenter design. Additional Information: The study hypothesis, monitored gaps in prior research, clinical significance, and qualifications of participant diagnosticians were included. The sample size calculation was expanded with references, and statistical analyses were revised for suitability. Amendments from Version 1 The revised version of the manuscript incorporates the corrections and suggestions provided by the reviewers. Several substantive and editorial improvements have been made to enhance clarity, methodological rigor, and compliance with journal requirements. Study Design Clarification: We explicitly clarified that the trial is prospective, with baseline, post‑intervention, and follow‑up data collection. Eligibility Criteria: The inclusion and exclusion criteria were rewritten to specify the types of chronic low back pain considered and the conditions excluded, ensuring greater transparency. Methodological Details: Expanded descriptions were added regarding participant selection, randomization, allocation, blinding procedures, exercise protocol, booklet contents, and outcome measures, including their reliability and validity. Abstract and Keywords: The abstract was thoroughly revised to state the study objective, duration, setting, participant characteristics, treatment procedures, outcome measures, and statistical tests. Keywords were replaced with appropriate MeSH terms. Editorial Compliance: The manuscript was reformatted to meet journal requirements, including word limits, number of keywords, and citation style. Discussion Enhancements: The discussion now emphasizes the rehabilitative implications of the study, highlighting how therapeutic exercise may influence vitamin D metabolism and functional recovery, while lifestyle education could support self‑regulation of vitamin D3 levels. Comparative Context: Differences between our study and Reference 10 were clarified, underscoring the novelty of our randomized, assessor‑blinded multicenter design. Additional Information: The study hypothesis, monitored gaps in prior research, clinical significance, and qualifications of participant diagnosticians were included. The sample size calculation was expanded with references, and statistical analyses were revised for suitability. See the authors' detailed response to the review by Giacomo Farì See the authors' detailed response to the review by Gopal Nambi READ REVIEWER RESPONSES Introduction Chronic Low back pain (CLBP) is identified as one of the leading contributors to global disease burden. 1 It is a commonly prevalent musculoskeletal condition among non-communicable diseases in all countries, ranging from developing to developed countries, and in all age groups from children to the elderly population; affecting almost everyone during their lifespan. 2 About 55–80% of people suffer from low back pain (LBP) in their lifetime, and the worldwide yearly cost of managing chronic LBP is estimated to be a trillion dollars. 3 The incidence of LBP is linked to several biopsychosocial aspects, including mechanical, traumatic, pathological and degenerative causes; bone health is known to be associated with both degenerative and mechanical types of LBP. 4 Approximately 50% of patients seeking treatment for LBP of over 3 months’ duration are found to be additionally suffering from vitamin D and other nutritional deficiencies. 5 One study suggests a mean decrease of vitamin D levels may increase overall body pain. 6 A systematic review reported that vitamin D has the potential to decrease pain and inflammation by modifying sensory neuron excitability and anti-inflammatory and pro-inflammatory cytokines. Alongside pain remission, vitamin D levels are linked to increases in muscle strength, which contribute to improving function in patients with LBP. 7 A strong relationship between LBP and decreased vitamin D levels is noted in elderly women. However, it is still debated whether low vitamin D can predict severe LBP in the general population. 8 The urban population monograph is moving towards a more sedentary lifestyle and extended sitting hours with almost 12 hours spent in sedentary office jobs in Bangladesh, and this is combined with less exposure to sunshine for city dwellers. This has led to an increased number of LBP cases with insufficient serum vitamin D levels in Bangladesh; those with a sedentary lifestyle and obesity form the majority of sufferers. 9 A quasi-experimental study shows that therapeutic exercise and vitamin D supplements can be a promising treatment to battle these LBP cases 10 ; however the study didn’t elaborate a specific protocol. Other studies suggest that aerobic exercise (low, moderate, high), stretching, balance, motor control exercises, core stability, coordination, muscular strength exercises, and flexibility programs are types of exercises that have a significant outcome on LBP. But because of the intricacy of LBP, it is uncertain which of these types of exercises has the best outcome for rehabilitation; this calls for more in depth studies. 10 , 11 Research also recommend the necessity of active rehabilitation, including therapeutic exercise (TE), which is emphasized in evidence-based guidelines for the therapy of CLBP, but there is no universal agreement on the most efficient type of exercises. 12 Vitamin D supplementation can be provided by different approaches including natural approaches, lifestyle education and oral vitamin D supplementation. However, it has been demonstrated that engaging in any type of regular physical exercise increases circulating vitamin D and upregulates the vitamin receptor expression in muscles. 13 An educational booklet is an effective intervention approach for health-care professionals to deliver regular education concerning the causes, mechanisms, natural history, and prognosis of LBP, and promote the benefits of physical activity and exercise. 14 In previous studies, booklets on lifestyle, exercise and sun exposure 14 , 15 or exercise and vitamin D3 supplementation 16 have found to be effective for CLBP. Therapeutic exercise and vitamin D supplements are effective for the Dhaka city dwellers in Bangladesh, 10 and creating an educational booklet can be a great solution to raising awareness of CLBP with vitamin D deficiency. 9 Educational booklets on exercise, sun exposure and healthy nutrition have proven to be promising in other studies. 14 , 15 From the researcher’s knowledge, no study comparing the use of “vitamin D supplements” or “booklet education on sun exposure, nutrition and lifestyle” along with therapeutic exercise for CLBP cases has been done. Chronic low back pain (CLBP) has been associated with vitamin D deficiency, which affects calcium metabolism, bone health, and muscle function. Deficiency may lead to osteomalacia, muscle weakness, and impaired neuromuscular control, increasing spinal instability and pain. Additionally, low vitamin D levels can elevate pro-inflammatory cytokines, intensifying pain sensitivity and contributing to chronic musculoskeletal disorders. 8 Clinical studies have reported a higher prevalence of vitamin D deficiency among patients with CLBP compared to healthy controls, suggesting a potential association between deficiency and pain severity. 17 , 18 Vitamin D supplementation has been explored as a supportive measure in CLBP due to its role in bone health, muscle strength, and inflammation regulation. 19 Correcting deficiency may improve musculoskeletal function and reduce pain sensitivity, with clinical trials reporting symptomatic improvement in deficient patients. 20 , 21 However, meta-analyses indicate limited overall efficacy, suggesting benefits may be restricted to those with confirmed deficiency, while excessive intake carries risks such as hypercalcemia and kidney stones. 22 This study hypothesizes that multidimensional comprehensive management through therapeutic exercise combined with an education booklet on sun exposure, nutrition, and lifestyle (TEB) will be superior to therapeutic exercise with oral vitamin D supplementation (TED) in patients with chronic low back pain and vitamin D deficiency. Specifically, it is expected that participants in the TEB group will demonstrate greater improvements in pain symptoms, serum vitamin D levels, and disability status compared to those in the TED group, with these effects observed at both 2 and 6 months following baseline recruitment. Following the study hypothesis, this trial holds clear clinical significance: for clinicians, it offers evidence to guide treatment choices between exercise combined with education or vitamin D3; for patients, it evaluates accessible, low-cost strategies that may improve pain and function; and for researchers, it provides rigorous comparative data to inform future studies on scalable interventions for CLBP. The specific objectives are: 1. To design a protocol of therapeutic exercise, along with an educational booklet on sun exposure, nutrition and lifestyle, and vitamin D supplementation for the CLBP patients with vitamin D deficiency. 2. To evaluate the effectiveness of therapeutic exercise along with an education booklet on sun exposure, nutrition and lifestyle, on painful symptoms, serum vitamin D level and disability for CLBP patients with vitamin D deficiency at 2 months and 6 months post-test compared to baseline. 3. To explore the effectiveness of therapeutic exercise along with oral vitamin D supplement on painful symptoms, serum vitamin D level and disability for CLBP patients with vitamin D deficiency at 2 months and 6 months post-test compared to baseline. 4. To study the comparative effectiveness of both groups on painful symptoms, serum vitamin D levels and disability for CLBP patients with vitamin D deficiency at 2 months and 6 months’ post-test compared to baseline. Methods Researchers plan for an assessor blinded two arm multicenter Randomized Clinical Trial (RCT) protocol to compare the efficacy of therapeutic exercise and an education booklet on sun exposure, nutrition and lifestyle versus therapeutic exercise and oral vitamin D supplement for CLBP patients with vitamin D deficiency at 2 months and 6 months after baseline recruitment in designated rehabilitation centers in Dhaka city. For this potential trial, researchers will follow Standard Protocol Items: Interventional Trials 2013 (SPIRIT) guidelines, to help ensure quality of the interventional trial ( Table 1 ). Table 1. Study protocols according to SPIRIT guidelines. Study (Status) Teams (Preparation) Patients (Execution) Preparation & planning Training to team Piloting Enroll Study Time Baseline 0 2 months 6 months Intervention × × × × × Enrollment × × × Informed Consent × × × Eligibility × × × Evaluations BPI × × × × × Vit. D3 × × × × × RMDQ × × × × × Abbreviations: BPI, Brief Pain Inventory; Vit. D3, Serum 25(OH)D; RMDQ, Roland Morris Disability Questionnaire. Study setting To meet the objectives of the trial and prevent trial contamination, the experimental group interventions will take place at the Centre for the Rehabilitation of the Paralysed (CRP) and control group interventions will take place at SAIC College of Medical Science & Technology. We expect to get cases with similar geographical and baseline criteria of city dwellers having CLBP. Data collection from different sites will increase the generalizability of the study and prevent cross-contamination of data. Eligibility criteria Participants will be included if they present with chronic low back pain (CLBP) of central origin, persisting for more than three months and classified under ICD-10-CM Code M54.5, with documented vitamin D deficiency defined as serum 25(OH)D3 levels below 20 ng/mL. 16 Eligible individuals must be adults aged 18 years or older, of either gender, residing or working in Dhaka city in office, industry, or corporate settings that involve static postures or desk jobs requiring at least six hours of sitting per day for an average of 22 days per month, and must provide informed consent. Exclusion criteria comprise comorbid conditions that may influence vitamin D metabolism or bone health, including rheumatoid arthritis, ankylosing spondylitis, osteomalacia, tuberculosis of the spine, or a history of osteoporotic fracture. Women over 50 years of age or those who are post-menopausal will also be excluded, 14 as will individuals with prior use of calcium or vitamin D3 supplements, resistance training, or high-impact weight-bearing activities within the past six months. Patients presenting with neurological red flags such as dural signs, positive straight leg raise test, or bowel/bladder incontinence will not be considered. Additional exclusions include current participation in another clinical study and withdrawal during the 8-week intervention period. Interventions Participants will receive interventions according to the registered study protocol, consisting of either therapeutic exercise combined with an educational booklet (TEB) or therapeutic exercise combined with oral vitamin D3 supplementation (TED). 23 Booklet contents (B): 24 – 26 The educational booklet provides lifestyle and self-management advice designed to complement therapeutic exercise. Key recommendations include: • Avoid prolonged static sitting or standing; alternate between sitting and standing during work. • Consume natural sources of vitamin D3 such as milk, yogurt, fortified cereals, orange juice, mushrooms, margarine, hard-boiled eggs, and sea fish (e.g., tuna, salmon). • Engage in 30–35 minutes of sun exposure between 11:00 am and 2:00 pm. • Maintain 7–8 hours of sleep per night. • Avoid stress, smoking, and alcohol consumption, while maintaining a healthy body weight. • Perform regular physical activity as part of daily routine. Therapeutic exercise protocol (TE): 27 – 29 Both groups will receive therapeutic exercises. Exercises will focus on both back pain and disability minimization of the participants. Each session will last for 25-30 minutes, 4 days per weeks and for 8 weeks. The progression of therapeutic exercise will be as per the registered protocol. Exercises are delivered under a physiotherapist supervision and include: • Postural advice (TH.1): Maintain erect posture in sitting and standing; avoid prolonged sitting/standing and forward bending. • McKenzie’s directional preference exercises (TH.2): Sustained positioning and repeated movements, most often extension-based, performed in sets of 10 repetitions. • Stretching exercises (TH.3): Targeting erector spinae, hamstrings, and triceps surae muscles. • Lumbar stabilization exercises (TH.4): Core strengthening to enhance spinal stability. • Weight-bearing aerobic exercises (TH.5): Jogging, stair climbing, and 30 minutes of brisk walking. • Heating modalities (TH.6): Infra-red radiation applied as adjunct therapy. Vitamin D supplementation (D): Participants in the TED group will receive 40,000 IU vitamin D3 capsules once weekly for 8 weeks, prescribed by a registered physician and manufactured by a licensed pharmaceutical company in Bangladesh. 23 We expect there will be no major adverse effect for therapeutic exercise and booklet group and that there will be no request of dosage change or worsening of patients’ condition. If any of these occur we will discuss with the patient. If the patient is not willing not to continue, we will stop the intervention, and keep the data for intention to treat analysis. The vitamin D supplement group may experience some adverse effect; we will manage as per the standard measures described in the “safety measures” section. The adherence to these interventions will be monitored through checklist (Extended data 1 37 ). We will also monitor adverse effect using a checklist (Extended data 2 37 ). Outcome measurement Primary outcome Pain The BPI (Brief Pain Inventory), comprising fifteen items, evaluates the degree of pain and how it affects everyday living. It measures pain interference in relationships, emotions, quality of life, and physical activities, including sleep, general activity, and walking; it also contains pain diagrams and questions regarding drugs and analgesics. Higher ratings indicate more acute pain and more interference. 30 With an interclass correlation coefficient (ICC) of 0.84–0.90 and kappa values over 0.70, the BPI exhibits great internal consistency (Cronbach's alpha = 0.91) and dependable test–retest results. 10 Vitamin-D3 level Serum 25(OH) D will be used to measure the level of Vitamin D3. Tests will be advised by an expert physician, and researchers will collect information from laboratory test reports. Patients will be categorized based on vitamin D levels, such as deficient (less than 20 ng/mL); insufficient (21 to 29 ng/mL); and sufficient (more than 30 to 100 ng/mL). 10 , 31 Secondary outcome Disability The RMDQ (Roland–Morris Questionnaire) is a 24-item patient-reported instrument that is intended to evaluate pain-related impairment resulting from LBP. Every item has a value of 0 if left blank or 1 if approved, therefore producing a total score between 0 and 24, with higher scores denoting greater impairment. 32 Whereas absolute reliability (Standard Error of Measurement, SEM) is estimated between 1.7 and 2.0 points, test-retest reliability usually falls within an intra-class correlation range of 0.79-0.88. 33 Participant timeline Sample size The sample size for this trial was determined based on methodological standards used in low back pain research. Previous studies have indicated that randomized controlled trials in chronic low back pain require a minimum of 152 participants to detect clinically meaningful superiority differences, with a significance level (α) of 0.05, statistical power of 80%, and a 95% confidence interval. Considering potential attrition, we plan to recruit additional participants to ensure adequate statistical power and robustness of findings. 34 , 35 Randomization Researchers plan for hospital-based randomization in both study centers from 1 st December 2022 to 30 th May 2023 by sequential random sampling and eligibility screening. Participants were randomly assigned to either the therapeutic exercise plus education booklet (TEB) group or the therapeutic exercise plus vitamin D3 supplementation (TED) group using a computer-generated randomization sequence. Randomization was stratified by study center to ensure balanced distribution across sites. Allocation concealment was maintained through the use of sequentially numbered, opaque, sealed envelopes prepared by an independent researcher not involved in recruitment or assessment. Blinding was implemented at multiple levels to minimize bias. Outcome assessors were blinded to group allocation throughout the study, ensuring objective evaluation of pain, disability, and serum vitamin D levels. Data analysts were also blinded to group identity during statistical analysis. Due to the nature of the interventions, participants and treating physiotherapists could not be blinded; however, strict separation between intervention delivery and outcome assessment was maintained to preserve methodological rigor. Recruitment and study procedure We will follow the Consolidated Standards of Reporting Trials (CONSORT) to maintain the standards of the study procedure ( Figure 1 ). For the initial recruitment the LBP patients attending outdoor clinics of both centers from 1st December 2022 to 30th May 2022 will be primarily screened by the outdoor team and provided participant information sheet (PIS) of the study. The final screening will be performed by two licensed physician specializing in physical medicine and rehabilitation. These physicians held postgraduate qualifications (MD/MS in Rehabilitation Medicine or Orthopedics) and had a minimum of 5–10 years of clinical experience in musculoskeletal disorders and pain management. The patient will meet the blinded assessor who will then take pretest data in a separate room, and collect a blood sample, before returning the patient to the outdoor pool. From outdoor pool, the patient will have a concealed envelop with another random ID number matched by the initial ID number given and meet the intervention provider (physiotherapist and physician or physiotherapist alone). Patient will receive the intervention provided in the written guideline enclosed in the concealed envelope. After 8 weeks of treatment completion, the patient will be further screened by blinded assessor, and another blood sample will be collected before discharge. After six months, the patient will be invited to the treatment center or visited in their house or workplace for follow up evaluation and blood sample collection. Therapeutic exercise will be provided by a graduate physiotherapist, and medication will be provided by a registered medical practitioner. Patient will pay for the physiotherapy treatment sessions but will not pay for any additional blood tests, medication or booklet. Figure 1. CONSORT diagram. Monitoring Patients will be monitored during the intervention session, and the medication chart and home exercise checklist (Extended data 1 37 ) will be maintained for recording the interventions. Patient data will be reviewed by a team from a different organization out of the study setting. The completed forms and questionnaire, along with blood report, will be evaluated by the monitoring team. Any kind of change or modifications to the methodology and intervention protocol will be communicated to the Ethics Committees. The research team will have access to the data and interim results and be in charge of making the final decision to change or end the study, hence carrying out interim analysis. Safety measures to avoid harmful effects Although it is expected that vitamin D3 supplementation and therapeutic exercise will not produce harmful effects on patients, patients should be instructed to inform the physician and physiotherapist if they feel any kind of discomfort (including-gastrointestinal, skin, musculoskeletal problem etc.) after the intervention. Before starting, the physiotherapist and physician will screen patients for any contraindications to intervention. If any serious harmful effects are found, researchers will report this during the final publication. The adverse effects reporting checklist will be provided during intervention (Extended data 2 37 ). Data analysis Data will be analyzed based on its nature. Calculation and data auditing will be done using Microsoft Excel 2016. Data will be analyzed by SPSS version 23, and R-4.2.1 for Windows. Eligibility for parametric analysis will be checked using bell’s curve, skewness, kurtosis, Kolmogorov–Smirnov test and Shapiro–Wilk test. Continuous variables will be represented by using an arithmetic mean and standard deviation. Categorical data will be represented by percentage (%) and frequency. Baseline characteristics between groups will be compared using chi-square tests for categorical variables and independent t-tests or Mann–Whitney U tests for continuous variables, depending on data distribution. Normality will be assessed using the Shapiro–Wilk test. For within-group comparisons across time points (baseline, 2 months, and 6 months), repeated measures ANOVA will be applied for parametric data, with Greenhouse–Geisser correction if sphericity is violated; the Friedman test will be used for non-parametric data. Between-group differences over time will be analyzed using mixed-model repeated measures ANOVA, which accounts for group × time interactions, or generalized estimating equations (GEE) if assumptions are not met. Post-hoc pairwise comparisons will be adjusted using Bonferroni correction. Effect sizes (Cohen’s d or partial eta squared) will be reported to indicate the magnitude of differences. All analyses will be conducted at a two-tailed alpha level of 0.05, and intention-to-treat principles will be applied to handle missing data. Ethical issues and informed consent According to ethical guidelines, the researchers will abide by the Helsinki declaration. The participants' participation will be entirely voluntary, and they will have the right to withdraw from the trial at any time during the trial. The participants will be assured that participation in or withdrawal from the study will not cause any change to their regular treatment program. Participants will sign the informed consent (Extended data 3 37 ). The Institute of Physiotherapy Rehabilitation and Research of the Bangladesh Physiotherapy Association (BPA) has provided ethical permission (BPA-IPRR/IRB/06/16/2060) on 16 th June 2022 to proceed with the study (Extended data 4 37 ). The trial has been registered with Clinical Trials Registry India ( CTRI/2022/11/047074 ) (Extended data 5 37 ). In case of any changes to the protocol, research team will notify to Institutional review board, the trial registry platform and in the later publications. The personal information of the participants will be confidential and stored unanimously in a dataset at the Department of nutrition and food technology at Jashore university of Science & Technology. Study status This study has concluded the assignment of health clinics, training of intervention provider, ethical approval and applied for trial registration. We anticipate beginning this trial on 1 st December 2022. Discussion There is an increasing concern of LBP and vitamin D deficiency for chronic pain suffers that is leading the working people towards disability and inefficiency to work. 5 , 9 A non-randomized quasi experimental study 10 found therapeutic exercise and vitamin D oral supplementation is effective to reduce pain, replenish vitamin D3 level with short term results. Our study will meet the necessity of randomized systematic evaluation of therapeutic exercises and vitamin D supplement compensation in two different approaches, either by sun exposure, nutrition and healthy lifestyle or by taking oral supplements. We will evaluate outcome in both short term (2 months) and long-term effect after 6 months of stopping the intervention. The experimental group is the therapeutic exercise and booklet group because we assume a positive lifestyle and exercise can replace the role of oral medication supplement, as these were derived as a predictor in observational studies. 9 The methodological standard of the proposed trial adheres to the Enhancing the QUAlity and Transparency Of health Research (EQUATOR) guidelines to ensure the rigor of the study. As this is a two tailed hypothesis, we assume any treatment can be superior or both may have similar effect. The similar effect is also a positive finding, because oral vitamin D supplement have some adverse effects if taken for longer durations. 12 Moreover, if the study would have four arms including two interventions, a group with only vitamin D supplement and another with therapeutic exercise and a placebo vitamin D supplement, that could ensure true effects. However, researchers had to limit the study considering funding, scope of practice and complicated management issues. As outcome indicators pain and vitamin D3 levels will be used as primary outcomes and disability as secondary outcome, because previous research suggests disability as a consequence. 36 BPI measures not only pain severity, but also pain affective interference and pain physical interference, 10 , 30 that is consistent to the effect of intervention. The findings of this study may provide important insights into the rehabilitative role of therapeutic exercise in chronic low back pain (CLBP). Beyond its established benefits for musculoskeletal function, exercise may influence the production, absorption, deposition, and overall metabolic function of serum vitamin D, thereby enhancing pain modulation and functional recovery. Evidence suggests that exercise improves vitamin D metabolism and reduces musculoskeletal pain through mechanisms such as modifying sensory neuron excitability and regulating both anti-inflammatory and pro-inflammatory cytokines, ultimately contributing to remission of disability. 7 If lifestyle education delivered through the booklet demonstrates positive behavioral changes, this could open new avenues for rehabilitation by promoting self-regulation of vitamin D3 levels and supporting natural remission of CLBP. Moreover, the combined approach of therapeutic exercise and supplementation may offer strategies to reduce recurrence or delay the episodic pattern of pain, adding to the repertoire of non-pharmacological options for CLBP therapy. Overall, these findings highlight the potential to broaden rehabilitative strategies by combining exercise-mediated regulation of vitamin D metabolism with conventional physiotherapy, thereby introducing innovative, evidence-based approaches for the management of chronic low back pain. Author contributions MSI, KMAH, MAZ contributed to Conceptualizing, Planning, Funding Acquisition, Investigation, Administration, Writing (review & editing), and approval. MSH, RP, IKJ, MFK contributed to Investigation, Conceptualizing, Supervision, and review. VR, NAU contributed to Conceptualizing, Writing (review &editing), and approval. Data accessibility Underlying data No underlying data are associated with this article. Extended data Mendeley Data: Therapeutic Exercise & Vitamin D for CLBP. https://doi.org/10.17632/d4hf2hjjxr.2 . 37 This project contains the following extended data: - Extended data 1: the medication chart and home exercise checklist - Extended data 2: the adverse effects reporting checklist - Extended data 3: Informed consent - Extended data 4: Institutional Review Board (IRB) permission - Extended data 5: Clinical Trial Registry - Extended data 6: SPIRIT Checklist Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Reporting guidelines For generating the protocol, we followed the Interventional Trials 2013 (SPIRIT) guidelines (Table 1), and for the RCT we will follow Consolidated statements for reporting randomized trials (CONSORT) guideline (Figure 1). Mendeley Data: SPIRIT checklist for ‘Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial’. https://doi.org/10.17632/d4hf2hjjxr.2 . 37 Data are available under the terms of the Creative Commons Attribution 4.0 International license (CC-BY 4.0). Acknowledgements Authors acknowledges the research assistants of “Amran’s School of thoughts” for their voluntary contribution to conceptualize the study. References 1. Froud R, Patterson S, Eldridge S, et al. : A systematic review and meta-synthesis of the impact of low back pain on people’s lives. BMC Musculoskelet. Disord. 2014; 15 (1): 1–4. 2. Hoy D, Bain C, Williams G, et al. : A systematic review of the global prevalence of low back pain. Arthritis Rheum. 2012; 64 (6): 2028–2037. Publisher Full Text 3. 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Publisher Full Text Comments on this article Comments (0) Version 2 VERSION 2 PUBLISHED 21 Nov 2022 ADD YOUR COMMENT Comment Author details Author details 1 Department of Nutrition & Food Technology, Jashore University of Science & Technology, Jashore, 7408, Bangladesh 2 Department of Physiotherapy & Rehabilitation, Jashore University of Science & Technology, Jashore, 7408, Bangladesh 3 Department of Physiotherapy, Bangladesh Health Professions Institute, Savar, 1343, Bangladesh 4 Department of Physiotherapy, School of Sport and Health Sciences, University of Brighton, Brighton, UK 5 Department of Microbiology, Jashore University of Science & Technology, Jashore, 7408, Bangladesh Muhammad Shahidul Islam Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Validation, Writing – Original Draft Preparation, Writing – Review & Editing K. M. Amran Hossain Roles: Conceptualization, Formal Analysis, Funding Acquisition, Investigation, Methodology, Resources, Software, Validation, Visualization, Writing – Original Draft Preparation, Writing – Review & Editing Md. Sohrab Hossain Roles: Conceptualization, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Validation, Writing – Review & Editing Rashida Parvin Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Software, Validation, Visualization, Writing – Review & Editing Nadia Afrin Urme Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Resources, Software, Validation, Visualization, Writing – Review & Editing Veena Raigangar Roles: Conceptualization, Formal Analysis, Investigation, Methodology, Resources, Software, Supervision, Validation, Writing – Original Draft Preparation, Writing – Review & Editing Iqbal Kabir Jahid Roles: Conceptualization, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Software, Supervision, Writing – Review & Editing Md. Feroz Kabir Roles: Conceptualization, Data Curation, Formal Analysis, Investigation, Methodology, Project Administration, Resources, Validation, Visualization, Writing – Review & Editing Md. Ashrafuzzaman Zahid Roles: Conceptualization, Data Curation, Formal Analysis, Funding Acquisition, Investigation, Methodology, Project Administration, Resources, Supervision, Writing – Original Draft Preparation, Writing – Review & Editing Competing interests No competing interests were disclosed. Grant information The author(s) declared that no grants were involved in supporting this work. Article Versions (2) version 2 Revised Published: 03 Mar 2026, 11:1352 https://doi.org/10.12688/f1000research.127948.2 version 1 Published: 21 Nov 2022, 11:1352 https://doi.org/10.12688/f1000research.127948.1 Copyright © 2026 Islam MS et al . This is an open access article distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Download Export To Sciwheel Bibtex EndNote ProCite Ref. Manager (RIS) Sente metrics Views Downloads F1000Research - - PubMed Central info_outline Data from PMC are received and updated monthly. - - Citations open_in_new 0 open_in_new 0 open_in_new SEE MORE DETAILS CITE how to cite this article Islam MS, Hossain KMA, Hossain MS et al. Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.12688/f1000research.127948.2 ) NOTE: If applicable, it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS track receive updates on this article Track an article to receive email alerts on any updates to this article. TRACK THIS ARTICLE Share Open Peer Review Current Reviewer Status: ? Key to Reviewer Statuses VIEW HIDE Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Version 2 VERSION 2 PUBLISHED 03 Mar 2026 Revised Views 0 Cite How to cite this report: Sidiq M and Suman A. Reviewer Report For: Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.5256/f1000research.196043.r466508 ) The direct URL for this report is: https://f1000research.com/articles/11-1352/v2#referee-response-466508 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 01 Apr 2026 Mohammad Sidiq , Tishk International University, Erbil, Iraq Akansha Suman , Department of Physiotherapy, School of Paramedical & Allied Health Sciences, Shri Guru Ram Rai University, Dehradun, Uttarakhand, India Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.196043.r466508 I would like to appreciate authors for this proposed trial but it needs some amendments as under: This protocol outlines a randomized trial to compare the effectiveness of two intervention strategies to treat chronic low back pain (CLBP) in ... Continue reading READ ALL I would like to appreciate authors for this proposed trial but it needs some amendments as under: This protocol outlines a randomized trial to compare the effectiveness of two intervention strategies to treat chronic low back pain (CLBP) in individuals with low vitamin D levels. The purposes of the trial are to compare the impact of therapeutic exercises in the context of either pain neuroscience education or vitamin D supplementation on pain, function, and other relevant outcomes of interest. The study protocol employs a randomized, assessor-blinded, multicenter, parallel-group design, which effectively addresses the research question. The research is of interest because of the high prevalence of CLBP and growing interest in both mind-related (education) and body-related (vitamin D) issues. The study addresses a significant gap, but there are areas where details of the study methodology and reporting need to be clarified for proper replication, reproduction, and rigor. Major Comments (Must Be Addressed) 1. Explanation of Research Gap The justification for the study is explained, but not why the research gap exists. Insufficient detail is provided in the manuscript on: • That evidence is insufficient • The contribution this new study makes compared to previous trials What's more, the objectives are not well prioritized: • The primary outcome must be identified • Secondary outcomes must be identified Recommendation: Make sure to clearly justify and identify novelty in the introduction. Separately state what is primary vs secondary 2. Sample Size The protocol is lacking a sound sample size calculation, which is an important design consideration. Recommendation: Include: • Estimated effect size (citation) • Power (typically 80–90%) • Alpha level • Estimated dropout rate • Estimated sample size 3. Methods of Randomization and Allocation Concealment Randomization is stated, but specific details are lacking, such as: • Randomization sequence generator (e.g., computer) • Mechanism used to conceal allocation (e.g., opaque sealed envelopes) Recommendation: Describe allocation of groups in detail and according to CONSORT to reduce bias in selection. 4. Interventions (To enable repetitive studies) General but little detail about the interventions: • Exercise type, intensity, progression and supervision • Pain neuroscience education content and format • Dose, frequency, duration and reason for vitamin D supplement • Adherence and compliance monitoring Recommendation: Include more detail on intervention using methods such as TIDieR 5. Statistical Analysis Plan The plan lacks sufficient specificity regarding the statistical analysis. • Approaches to missing data (e.g., intention-to-treat) • Adjustment for baseline covariates • Adjustment for baseline covariates • Subgroup or "post-hoc" analyses Recommendation: Offer a full statistical analysis plan for greater transparency. 6. Outcomes and timepoints Even though outcomes are discussed, the protocol does not include: • clear specification of a primary outcome measure • Tabulated display of timepoints for assessments • Rationale for choice of outcomes Recommendation: Provide a table that includes: • Primary and secondary outcomes • Measurement tools • Time (baseline, follow-up) You can also include MCID. Minor Comments (Should Be Addressed) 1. Blinding and Bias • The assessors were blinded • But participants cannot be blinded, and this introduces bias See discussion of performance and expectation bias. 2. Confounding Variables Potential confounders are not controlled for: • Sunlight exposure • Dietary vitamin D intake • Levels of physical activity Add measures to either control for these variables or plan for recording them. 3. Ethical Considerations Consent is sought, but: • Ensure safety monitoring is detailed for vitamin D supplements Include procedures for safety monitoring and adverse events 4. Trial Registration • Take care to ensure the trial number is clearly identified. 5. Language and Structure • Some grammatical improvements needed • Some improvements to be made for clarity Overall Recommendation Major Revision The protocol poses a relevant and timely clinical question, suitable for a randomized controlled evaluation. But important study details are missing, particularly in terms of sample size, study intervention, outcome measures, and statistical considerations. This is important to ensure the study is rigorously conducted, replicable, and meets international reporting guidelines. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests: No competing interests were disclosed. Reviewer Expertise: Musculoskeletal, Pain Sciences and Public Health We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Sidiq M and Suman A. Reviewer Report For: Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.5256/f1000research.196043.r466508 ) The direct URL for this report is: https://f1000research.com/articles/11-1352/v2#referee-response-466508 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Sotiropoulos S. Reviewer Report For: Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.5256/f1000research.196043.r464590 ) The direct URL for this report is: https://f1000research.com/articles/11-1352/v2#referee-response-464590 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 25 Mar 2026 Spyridon Sotiropoulos , University of West Attica, Athens, Greece Approved VIEWS 0 https://doi.org/10.5256/f1000research.196043.r464590 This manuscript presents a study protocol for a two-arm, assessor-blinded randomized clinical trial investigating the additional effect of vitamin D3 supplementation compared with an educational booklet when combined with therapeutic exercise in individuals with chronic low back pain and vitamin ... Continue reading READ ALL This manuscript presents a study protocol for a two-arm, assessor-blinded randomized clinical trial investigating the additional effect of vitamin D3 supplementation compared with an educational booklet when combined with therapeutic exercise in individuals with chronic low back pain and vitamin D deficiency. The topic is clinically relevant, given the high prevalence of both low back pain and hypovitaminosis D, and the growing interest in multimodal management strategies. The rationale and objectives are clearly described. The authors provide a coherent background linking vitamin D deficiency with musculoskeletal pain, and they articulate a clear hypothesis alongside well-defined primary and secondary objectives. Although the background appropriately acknowledges that existing evidence is mixed, some statements may still lean toward overstating the potential benefits of vitamin D supplementation. Nonetheless, the justification for conducting the trial is reasonable and clearly presented. The overall study design—a randomized, assessor-blinded trial—is appropriate for the research question and reflects a pragmatic approach consistent with physiotherapy practice. However, a key methodological concern remains insufficiently addressed. The allocation of different intervention arms to separate centers introduces a risk of confounding between treatment and study site. Differences in patient populations, clinician behavior, or contextual factors across centers may influence outcomes independently of the intervention. While the authors note stratification by study center, this approach does not fully resolve the issue if intervention and center are structurally linked. The manuscript would be strengthened by explicitly describing how site effects will be accounted for in the statistical analysis (e.g., inclusion as a fixed or random effect) or by providing a stronger justification for this design choice. The methods are described in substantial detail and are generally sufficient to support replication. Eligibility criteria, intervention protocols, outcome measures, and timelines are clearly specified. The inclusion of assessor and data analyst blinding is a strength. Adherence to interventions is addressed through the use of medication charts and exercise checklists, and adverse events are monitored systematically. The statistical analysis plan is also well developed, including intention-to-treat principles, appropriate modeling approaches, and reporting of effect sizes. However, further clarification on the handling of site-related effects within the analysis would improve methodological transparency. As expected for a study protocol, no dataset is presented. The authors provide comprehensive supporting materials, including checklists, consent forms, and trial documentation, which enhances transparency and reproducibility. A brief statement outlining how and when the final dataset will be shared would further strengthen alignment with open science practices. In summary, this is a well-structured and clinically relevant protocol with generally strong methodological detail. The primary issue requiring attention is the potential for center-related confounding due to the allocation of interventions across sites. Addressing this concern would strengthen the internal validity of the study. Secondary improvements relate to clarifying data-sharing plans. These issues are addressable and do not fundamentally undermine the overall study design. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: Musculoskeletal physiotherapy, chronic low back pain, exercise therapy, non-pharmacological interventions, clinical trial methodology and rehabilitation research. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Sotiropoulos S. Reviewer Report For: Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.5256/f1000research.196043.r464590 ) The direct URL for this report is: https://f1000research.com/articles/11-1352/v2#referee-response-464590 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Respond or Comment COMMENT ON THIS REPORT Version 1 VERSION 1 PUBLISHED 21 Nov 2022 Views 0 Cite How to cite this report: Nambi G. Reviewer Report For: Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.5256/f1000research.140494.r181246 ) The direct URL for this report is: https://f1000research.com/articles/11-1352/v1#referee-response-181246 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 29 Jun 2023 Gopal Nambi , Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia Not Approved VIEWS 0 https://doi.org/10.5256/f1000research.140494.r181246 Dear Authors Thanks a lot for the opportunity you have offered me to revise the fascinating manuscript, "Comparison of the effects of therapeutic exercise...randomized clinical trial". I thank the authors for their effort in producing this exciting manuscript. ... Continue reading READ ALL Dear Authors Thanks a lot for the opportunity you have offered me to revise the fascinating manuscript, "Comparison of the effects of therapeutic exercise...randomized clinical trial". I thank the authors for their effort in producing this exciting manuscript. From the editing point of view, I recommend the authors to fully respect the editing requirements imposed by this scientific journal and clearly indicated in the template. More specifically, I mean: the number of words in the abstract and manuscript, the number of keywords and the way to indicate the bibliographic sources. As a significant strength: This proposal is a novelty in the field and adds information to the existing evidence in the literature produced in the field. As a major weakness: The manuscript lacks details and clarity concerning methodological steps that would help improve the understanding of the manuscript. Keywords: use MeSH keywords Abstract: The background of the study talks only about CLBP. The objective of the study is not clear. Mention the study duration and study setting. Mention the character of the study participants. Mention the treatment procedure in short. Mention the outcome measures in short and its duration of measurement. Mention the statistical tests used for the study. Manuscript Mention the acronym of abbreviation when it is used for the first time. Please recheck the reference number 5. Mention the relation between CLBP and vitamin D deficiency in detail. Mention in detail about Vit D supplement, its role, merits and demerits in CLBP. How come this study is differing from the reference study 10? Mention the gaps monitored by the researcher in the previous studies. Mention the study hypothesis. Include the clinical significance of this study over clinicians, patients, and researchers after the study hypothesis. Mention who has diagnosed the participants and their qualification and experience. Mention the detail information about randomization, allocation and blinding. Mention in detail about the exercise protocol and the contents involved in booklet. Mention the outcome measures measured in the study and its reliability and validity. Mention the sample size calculation with reference. The information provided is not sufficient. Mention the statistical tests included in the study. The tests mentioned are not suitable. Is the rationale for, and objectives of, the study clearly described? No Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Partly Competing Interests: No competing interests were disclosed. Reviewer Expertise: Musculoskeletal and sports physiotherapy I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Nambi G. Reviewer Report For: Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.5256/f1000research.140494.r181246 ) The direct URL for this report is: https://f1000research.com/articles/11-1352/v1#referee-response-181246 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 03 Mar 2026 Dr. Kazi Md. Amran Hossain, PT , Department of Physiotherapy & Rehabilitation, Jashore University of Science & Technology, Jashore, 7408, Bangladesh 03 Mar 2026 Author Response Reviewer 2 Comment 1: From the editing point of view, I recommend the authors to fully respect the editing requirements imposed by this scientific journal and clearly indicated in the ... Continue reading Reviewer 2 Comment 1: From the editing point of view, I recommend the authors to fully respect the editing requirements imposed by this scientific journal and clearly indicated in the template. More specifically, I mean: the number of words in the abstract and manuscript, the number of keywords and the way to indicate the bibliographic sources. Response: We thank the reviewer for this valuable observation and have carefully revised the manuscript to ensure full compliance with the journal’s editorial requirements. The abstract has been shortened to meet the word limit, the number of keywords has been adjusted according to the journal’s specifications, and all bibliographic references have been reformatted to strictly follow the prescribed citation style. In addition, we verified that the overall manuscript length now falls within the required limits. We believe these revisions address the reviewer’s concern and ensure that the manuscript fully respects the journal’s formatting and editing standards. Comment 2: As a significant strength: This proposal is a novelty in the field and adds information to the existing evidence in the literature produced in the field. Response: We sincerely appreciate the reviewer’s recognition of the novelty and contribution of our proposal. We agree that the study introduces an innovative perspective in the field and adds valuable information to the existing body of evidence. By addressing current gaps and integrating findings with the broader literature, we believe our work strengthens the scientific understanding and provides meaningful insights that can guide future research and clinical practice. Comment 3: As a major weakness: The manuscript lacks details and clarity concerning methodological steps that would help improve the understanding of the manuscript. Response: We thank the reviewer for this constructive observation and acknowledge the importance of providing clear methodological details to enhance the transparency and reproducibility of our work. In the revised manuscript, we have expanded the description of the methodological steps, including participant selection criteria, intervention procedures, outcome measures, and statistical analyses. These additions aim to improve clarity and allow readers to better understand the study design and implementation. We believe that the revisions now address the reviewer’s concern and strengthen the methodological rigor and comprehensibility of the manuscript. Comment 4: Keywords: use MeSH keywords Abstract: The background of the study talks only about CLBP. The objective of the study is not clear. Mention the study duration and study setting. Mention the character of the study participants. Mention the treatment procedure in short. Mention the outcome measures in short and its duration of measurement. Mention the statistical tests used for the study. Response: We thank the reviewer for these constructive suggestions regarding the abstract and keywords. In the revised manuscript, we have replaced the keywords with appropriate MeSH terms to ensure consistency with indexing standards. The abstract has been thoroughly revised to provide a clearer and more comprehensive overview of the study. Specifically, the background now contextualizes the research beyond chronic low back pain (CLBP), the study objective has been explicitly stated, and details regarding the study duration and setting have been included. We have also described the characteristics of the study participants, summarized the treatment procedure, and briefly outlined the outcome measures along with the timing of their assessment. Finally, the statistical tests employed in the analysis have been mentioned to enhance transparency. We believe these revisions improve the clarity and completeness of the abstract and align it more closely with the journal’s requirements. Comment 5: How come this study is differing from the reference study 10? Response: We appreciate the reviewer’s observation regarding the differences between our study and Reference 10. The study by Ali et al. (2021) investigated the combined effect of vitamin D supplementation and physiotherapy in patients with musculoskeletal disorders using a quasi-experimental design. In contrast, our study specifically focuses on chronic low back pain and employs a randomized, assessor-blinded, multicenter clinical trial design to compare the effects of therapeutic exercise when combined either with an educational booklet or with vitamin D3 supplementation. Thus, while both studies examine the role of vitamin D in musculoskeletal pain, our trial differs in its methodological rigor, target population, and intervention comparison, aiming to provide higher-level evidence on the relative effectiveness of exercise combined with different adjuncts in CLBP management. Comment 6: Mention the gaps monitored by the researcher in the previous studies. Mention the study hypothesis. Include the clinical significance of this study over clinicians, patients, and researchers after the study hypothesis. Mention who has diagnosed the participants and their qualification and experience. Mention the detail information about randomization, allocation and blinding. Mention in detail about the exercise protocol and the contents involved in booklet. Mention the outcome measures measured in the study and its reliability and validity. Mention the sample size calculation with reference. The information provided is not sufficient. Mention the statistical tests included in the study. The tests mentioned are not suitable. Response: We thank the reviewer for these constructive suggestions. In the revised manuscript, we addressed the issues throughout the manuscript. Thank you. Reviewer 2 Comment 1: From the editing point of view, I recommend the authors to fully respect the editing requirements imposed by this scientific journal and clearly indicated in the template. More specifically, I mean: the number of words in the abstract and manuscript, the number of keywords and the way to indicate the bibliographic sources. Response: We thank the reviewer for this valuable observation and have carefully revised the manuscript to ensure full compliance with the journal’s editorial requirements. The abstract has been shortened to meet the word limit, the number of keywords has been adjusted according to the journal’s specifications, and all bibliographic references have been reformatted to strictly follow the prescribed citation style. In addition, we verified that the overall manuscript length now falls within the required limits. We believe these revisions address the reviewer’s concern and ensure that the manuscript fully respects the journal’s formatting and editing standards. Comment 2: As a significant strength: This proposal is a novelty in the field and adds information to the existing evidence in the literature produced in the field. Response: We sincerely appreciate the reviewer’s recognition of the novelty and contribution of our proposal. We agree that the study introduces an innovative perspective in the field and adds valuable information to the existing body of evidence. By addressing current gaps and integrating findings with the broader literature, we believe our work strengthens the scientific understanding and provides meaningful insights that can guide future research and clinical practice. Comment 3: As a major weakness: The manuscript lacks details and clarity concerning methodological steps that would help improve the understanding of the manuscript. Response: We thank the reviewer for this constructive observation and acknowledge the importance of providing clear methodological details to enhance the transparency and reproducibility of our work. In the revised manuscript, we have expanded the description of the methodological steps, including participant selection criteria, intervention procedures, outcome measures, and statistical analyses. These additions aim to improve clarity and allow readers to better understand the study design and implementation. We believe that the revisions now address the reviewer’s concern and strengthen the methodological rigor and comprehensibility of the manuscript. Comment 4: Keywords: use MeSH keywords Abstract: The background of the study talks only about CLBP. The objective of the study is not clear. Mention the study duration and study setting. Mention the character of the study participants. Mention the treatment procedure in short. Mention the outcome measures in short and its duration of measurement. Mention the statistical tests used for the study. Response: We thank the reviewer for these constructive suggestions regarding the abstract and keywords. In the revised manuscript, we have replaced the keywords with appropriate MeSH terms to ensure consistency with indexing standards. The abstract has been thoroughly revised to provide a clearer and more comprehensive overview of the study. Specifically, the background now contextualizes the research beyond chronic low back pain (CLBP), the study objective has been explicitly stated, and details regarding the study duration and setting have been included. We have also described the characteristics of the study participants, summarized the treatment procedure, and briefly outlined the outcome measures along with the timing of their assessment. Finally, the statistical tests employed in the analysis have been mentioned to enhance transparency. We believe these revisions improve the clarity and completeness of the abstract and align it more closely with the journal’s requirements. Comment 5: How come this study is differing from the reference study 10? Response: We appreciate the reviewer’s observation regarding the differences between our study and Reference 10. The study by Ali et al. (2021) investigated the combined effect of vitamin D supplementation and physiotherapy in patients with musculoskeletal disorders using a quasi-experimental design. In contrast, our study specifically focuses on chronic low back pain and employs a randomized, assessor-blinded, multicenter clinical trial design to compare the effects of therapeutic exercise when combined either with an educational booklet or with vitamin D3 supplementation. Thus, while both studies examine the role of vitamin D in musculoskeletal pain, our trial differs in its methodological rigor, target population, and intervention comparison, aiming to provide higher-level evidence on the relative effectiveness of exercise combined with different adjuncts in CLBP management. Comment 6: Mention the gaps monitored by the researcher in the previous studies. Mention the study hypothesis. Include the clinical significance of this study over clinicians, patients, and researchers after the study hypothesis. Mention who has diagnosed the participants and their qualification and experience. Mention the detail information about randomization, allocation and blinding. Mention in detail about the exercise protocol and the contents involved in booklet. Mention the outcome measures measured in the study and its reliability and validity. Mention the sample size calculation with reference. The information provided is not sufficient. Mention the statistical tests included in the study. The tests mentioned are not suitable. Response: We thank the reviewer for these constructive suggestions. In the revised manuscript, we addressed the issues throughout the manuscript. Thank you. Competing Interests: No competing interest. Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 03 Mar 2026 Dr. Kazi Md. Amran Hossain, PT , Department of Physiotherapy & Rehabilitation, Jashore University of Science & Technology, Jashore, 7408, Bangladesh 03 Mar 2026 Author Response Reviewer 2 Comment 1: From the editing point of view, I recommend the authors to fully respect the editing requirements imposed by this scientific journal and clearly indicated in the ... Continue reading Reviewer 2 Comment 1: From the editing point of view, I recommend the authors to fully respect the editing requirements imposed by this scientific journal and clearly indicated in the template. More specifically, I mean: the number of words in the abstract and manuscript, the number of keywords and the way to indicate the bibliographic sources. Response: We thank the reviewer for this valuable observation and have carefully revised the manuscript to ensure full compliance with the journal’s editorial requirements. The abstract has been shortened to meet the word limit, the number of keywords has been adjusted according to the journal’s specifications, and all bibliographic references have been reformatted to strictly follow the prescribed citation style. In addition, we verified that the overall manuscript length now falls within the required limits. We believe these revisions address the reviewer’s concern and ensure that the manuscript fully respects the journal’s formatting and editing standards. Comment 2: As a significant strength: This proposal is a novelty in the field and adds information to the existing evidence in the literature produced in the field. Response: We sincerely appreciate the reviewer’s recognition of the novelty and contribution of our proposal. We agree that the study introduces an innovative perspective in the field and adds valuable information to the existing body of evidence. By addressing current gaps and integrating findings with the broader literature, we believe our work strengthens the scientific understanding and provides meaningful insights that can guide future research and clinical practice. Comment 3: As a major weakness: The manuscript lacks details and clarity concerning methodological steps that would help improve the understanding of the manuscript. Response: We thank the reviewer for this constructive observation and acknowledge the importance of providing clear methodological details to enhance the transparency and reproducibility of our work. In the revised manuscript, we have expanded the description of the methodological steps, including participant selection criteria, intervention procedures, outcome measures, and statistical analyses. These additions aim to improve clarity and allow readers to better understand the study design and implementation. We believe that the revisions now address the reviewer’s concern and strengthen the methodological rigor and comprehensibility of the manuscript. Comment 4: Keywords: use MeSH keywords Abstract: The background of the study talks only about CLBP. The objective of the study is not clear. Mention the study duration and study setting. Mention the character of the study participants. Mention the treatment procedure in short. Mention the outcome measures in short and its duration of measurement. Mention the statistical tests used for the study. Response: We thank the reviewer for these constructive suggestions regarding the abstract and keywords. In the revised manuscript, we have replaced the keywords with appropriate MeSH terms to ensure consistency with indexing standards. The abstract has been thoroughly revised to provide a clearer and more comprehensive overview of the study. Specifically, the background now contextualizes the research beyond chronic low back pain (CLBP), the study objective has been explicitly stated, and details regarding the study duration and setting have been included. We have also described the characteristics of the study participants, summarized the treatment procedure, and briefly outlined the outcome measures along with the timing of their assessment. Finally, the statistical tests employed in the analysis have been mentioned to enhance transparency. We believe these revisions improve the clarity and completeness of the abstract and align it more closely with the journal’s requirements. Comment 5: How come this study is differing from the reference study 10? Response: We appreciate the reviewer’s observation regarding the differences between our study and Reference 10. The study by Ali et al. (2021) investigated the combined effect of vitamin D supplementation and physiotherapy in patients with musculoskeletal disorders using a quasi-experimental design. In contrast, our study specifically focuses on chronic low back pain and employs a randomized, assessor-blinded, multicenter clinical trial design to compare the effects of therapeutic exercise when combined either with an educational booklet or with vitamin D3 supplementation. Thus, while both studies examine the role of vitamin D in musculoskeletal pain, our trial differs in its methodological rigor, target population, and intervention comparison, aiming to provide higher-level evidence on the relative effectiveness of exercise combined with different adjuncts in CLBP management. Comment 6: Mention the gaps monitored by the researcher in the previous studies. Mention the study hypothesis. Include the clinical significance of this study over clinicians, patients, and researchers after the study hypothesis. Mention who has diagnosed the participants and their qualification and experience. Mention the detail information about randomization, allocation and blinding. Mention in detail about the exercise protocol and the contents involved in booklet. Mention the outcome measures measured in the study and its reliability and validity. Mention the sample size calculation with reference. The information provided is not sufficient. Mention the statistical tests included in the study. The tests mentioned are not suitable. Response: We thank the reviewer for these constructive suggestions. In the revised manuscript, we addressed the issues throughout the manuscript. Thank you. Reviewer 2 Comment 1: From the editing point of view, I recommend the authors to fully respect the editing requirements imposed by this scientific journal and clearly indicated in the template. More specifically, I mean: the number of words in the abstract and manuscript, the number of keywords and the way to indicate the bibliographic sources. Response: We thank the reviewer for this valuable observation and have carefully revised the manuscript to ensure full compliance with the journal’s editorial requirements. The abstract has been shortened to meet the word limit, the number of keywords has been adjusted according to the journal’s specifications, and all bibliographic references have been reformatted to strictly follow the prescribed citation style. In addition, we verified that the overall manuscript length now falls within the required limits. We believe these revisions address the reviewer’s concern and ensure that the manuscript fully respects the journal’s formatting and editing standards. Comment 2: As a significant strength: This proposal is a novelty in the field and adds information to the existing evidence in the literature produced in the field. Response: We sincerely appreciate the reviewer’s recognition of the novelty and contribution of our proposal. We agree that the study introduces an innovative perspective in the field and adds valuable information to the existing body of evidence. By addressing current gaps and integrating findings with the broader literature, we believe our work strengthens the scientific understanding and provides meaningful insights that can guide future research and clinical practice. Comment 3: As a major weakness: The manuscript lacks details and clarity concerning methodological steps that would help improve the understanding of the manuscript. Response: We thank the reviewer for this constructive observation and acknowledge the importance of providing clear methodological details to enhance the transparency and reproducibility of our work. In the revised manuscript, we have expanded the description of the methodological steps, including participant selection criteria, intervention procedures, outcome measures, and statistical analyses. These additions aim to improve clarity and allow readers to better understand the study design and implementation. We believe that the revisions now address the reviewer’s concern and strengthen the methodological rigor and comprehensibility of the manuscript. Comment 4: Keywords: use MeSH keywords Abstract: The background of the study talks only about CLBP. The objective of the study is not clear. Mention the study duration and study setting. Mention the character of the study participants. Mention the treatment procedure in short. Mention the outcome measures in short and its duration of measurement. Mention the statistical tests used for the study. Response: We thank the reviewer for these constructive suggestions regarding the abstract and keywords. In the revised manuscript, we have replaced the keywords with appropriate MeSH terms to ensure consistency with indexing standards. The abstract has been thoroughly revised to provide a clearer and more comprehensive overview of the study. Specifically, the background now contextualizes the research beyond chronic low back pain (CLBP), the study objective has been explicitly stated, and details regarding the study duration and setting have been included. We have also described the characteristics of the study participants, summarized the treatment procedure, and briefly outlined the outcome measures along with the timing of their assessment. Finally, the statistical tests employed in the analysis have been mentioned to enhance transparency. We believe these revisions improve the clarity and completeness of the abstract and align it more closely with the journal’s requirements. Comment 5: How come this study is differing from the reference study 10? Response: We appreciate the reviewer’s observation regarding the differences between our study and Reference 10. The study by Ali et al. (2021) investigated the combined effect of vitamin D supplementation and physiotherapy in patients with musculoskeletal disorders using a quasi-experimental design. In contrast, our study specifically focuses on chronic low back pain and employs a randomized, assessor-blinded, multicenter clinical trial design to compare the effects of therapeutic exercise when combined either with an educational booklet or with vitamin D3 supplementation. Thus, while both studies examine the role of vitamin D in musculoskeletal pain, our trial differs in its methodological rigor, target population, and intervention comparison, aiming to provide higher-level evidence on the relative effectiveness of exercise combined with different adjuncts in CLBP management. Comment 6: Mention the gaps monitored by the researcher in the previous studies. Mention the study hypothesis. Include the clinical significance of this study over clinicians, patients, and researchers after the study hypothesis. Mention who has diagnosed the participants and their qualification and experience. Mention the detail information about randomization, allocation and blinding. Mention in detail about the exercise protocol and the contents involved in booklet. Mention the outcome measures measured in the study and its reliability and validity. Mention the sample size calculation with reference. The information provided is not sufficient. Mention the statistical tests included in the study. The tests mentioned are not suitable. Response: We thank the reviewer for these constructive suggestions. In the revised manuscript, we addressed the issues throughout the manuscript. Thank you. Competing Interests: No competing interest. Close Report a concern COMMENT ON THIS REPORT Views 0 Cite How to cite this report: Farì G. Reviewer Report For: Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.5256/f1000research.140494.r181251 ) The direct URL for this report is: https://f1000research.com/articles/11-1352/v1#referee-response-181251 NOTE: it is important to ensure the information in square brackets after the title is included in this citation. Close Copy Citation Details Reviewer Report 28 Jun 2023 Giacomo Farì , Department of Basic Sciences, Neuroscience and Sense Organs, Aldo Moro University of Bari, Bari, Italy Approved with Reservations VIEWS 0 https://doi.org/10.5256/f1000research.140494.r181251 This protocol is interesting and in line with the aims of this journal. Some concerns have to be addressed. I really appreciate that you provided the clinical trial registration and the IRB approval, but it is still ... Continue reading READ ALL This protocol is interesting and in line with the aims of this journal. Some concerns have to be addressed. I really appreciate that you provided the clinical trial registration and the IRB approval, but it is still not clear if this study will be a prospective or a retrospective one? Then, since you compare three interventions, very different from each other, you should better define the inclusion/exclusion criteria: which Low back pain will you consider? Which diseases will be excluded and which ones no? Finally, to improve the rehabilitative lapels of this study, you should explain in the discussion how your results could add new options for chronic low back pain therapy and rehabilitation. Best regards and good luck Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests: No competing interests were disclosed. Reviewer Expertise: rehabilitation I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. Close READ LESS CITE CITE HOW TO CITE THIS REPORT Farì G. Reviewer Report For: Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.5256/f1000research.140494.r181251 ) The direct URL for this report is: https://f1000research.com/articles/11-1352/v1#referee-response-181251 NOTE: it is important to ensure the information in square brackets after the title is included in all citations of this article. COPY CITATION DETAILS Report a concern Author Response 03 Mar 2026 Dr. Kazi Md. Amran Hossain, PT , Department of Physiotherapy & Rehabilitation, Jashore University of Science & Technology, Jashore, 7408, Bangladesh 03 Mar 2026 Author Response Reviewer 1 This protocol is interesting and in line with the aims of this journal. Some concerns have to be addressed. Comment 1: I really appreciate that you provided the ... Continue reading Reviewer 1 This protocol is interesting and in line with the aims of this journal. Some concerns have to be addressed. Comment 1: I really appreciate that you provided the clinical trial registration and the IRB approval, but it is still not clear if this study will be a prospective or a retrospective one? Response: Thank you for your valuable comment. It is indeed a prospective study. I have completed the baseline and post intervention data collection now we are collecting the follow-up information of the participants. Comment 2: Then, since you compare three interventions, very different from each other, you should better define the inclusion/exclusion criteria: which Low back pain will you consider? Which diseases will be excluded and which ones no? Response: Thank you for your valuable comment. We have rewritten the exclusion criteria subsection of the manuscript according to your suggestions. Comment 3: Finally, to improve the rehabilitative aspects of this study, you should explain in the discussion how your results could add new options for chronic low back pain therapy and rehabilitation. Response: We appreciate the reviewer’s suggestion to clarify how our findings could contribute to rehabilitation strategies for chronic low back pain. In the revised discussion, we have emphasized the potential rehabilitative implications of our study. Specifically, we highlight that therapeutic exercise may not only reduce musculoskeletal pain and disability but also play a role in regulating vitamin D metabolism, thereby offering a novel mechanism for functional recovery. We further explain that lifestyle education, if effective, could promote self‑regulation of vitamin D3 levels and support natural remission of CLBP. Thank you. Reviewer 1 This protocol is interesting and in line with the aims of this journal. Some concerns have to be addressed. Comment 1: I really appreciate that you provided the clinical trial registration and the IRB approval, but it is still not clear if this study will be a prospective or a retrospective one? Response: Thank you for your valuable comment. It is indeed a prospective study. I have completed the baseline and post intervention data collection now we are collecting the follow-up information of the participants. Comment 2: Then, since you compare three interventions, very different from each other, you should better define the inclusion/exclusion criteria: which Low back pain will you consider? Which diseases will be excluded and which ones no? Response: Thank you for your valuable comment. We have rewritten the exclusion criteria subsection of the manuscript according to your suggestions. Comment 3: Finally, to improve the rehabilitative aspects of this study, you should explain in the discussion how your results could add new options for chronic low back pain therapy and rehabilitation. Response: We appreciate the reviewer’s suggestion to clarify how our findings could contribute to rehabilitation strategies for chronic low back pain. In the revised discussion, we have emphasized the potential rehabilitative implications of our study. Specifically, we highlight that therapeutic exercise may not only reduce musculoskeletal pain and disability but also play a role in regulating vitamin D metabolism, thereby offering a novel mechanism for functional recovery. We further explain that lifestyle education, if effective, could promote self‑regulation of vitamin D3 levels and support natural remission of CLBP. Thank you. Competing Interests: No Close Report a concern Respond or Comment COMMENTS ON THIS REPORT Author Response 03 Mar 2026 Dr. Kazi Md. Amran Hossain, PT , Department of Physiotherapy & Rehabilitation, Jashore University of Science & Technology, Jashore, 7408, Bangladesh 03 Mar 2026 Author Response Reviewer 1 This protocol is interesting and in line with the aims of this journal. Some concerns have to be addressed. Comment 1: I really appreciate that you provided the ... Continue reading Reviewer 1 This protocol is interesting and in line with the aims of this journal. Some concerns have to be addressed. Comment 1: I really appreciate that you provided the clinical trial registration and the IRB approval, but it is still not clear if this study will be a prospective or a retrospective one? Response: Thank you for your valuable comment. It is indeed a prospective study. I have completed the baseline and post intervention data collection now we are collecting the follow-up information of the participants. Comment 2: Then, since you compare three interventions, very different from each other, you should better define the inclusion/exclusion criteria: which Low back pain will you consider? Which diseases will be excluded and which ones no? Response: Thank you for your valuable comment. We have rewritten the exclusion criteria subsection of the manuscript according to your suggestions. Comment 3: Finally, to improve the rehabilitative aspects of this study, you should explain in the discussion how your results could add new options for chronic low back pain therapy and rehabilitation. Response: We appreciate the reviewer’s suggestion to clarify how our findings could contribute to rehabilitation strategies for chronic low back pain. In the revised discussion, we have emphasized the potential rehabilitative implications of our study. Specifically, we highlight that therapeutic exercise may not only reduce musculoskeletal pain and disability but also play a role in regulating vitamin D metabolism, thereby offering a novel mechanism for functional recovery. We further explain that lifestyle education, if effective, could promote self‑regulation of vitamin D3 levels and support natural remission of CLBP. Thank you. Reviewer 1 This protocol is interesting and in line with the aims of this journal. Some concerns have to be addressed. Comment 1: I really appreciate that you provided the clinical trial registration and the IRB approval, but it is still not clear if this study will be a prospective or a retrospective one? Response: Thank you for your valuable comment. It is indeed a prospective study. I have completed the baseline and post intervention data collection now we are collecting the follow-up information of the participants. Comment 2: Then, since you compare three interventions, very different from each other, you should better define the inclusion/exclusion criteria: which Low back pain will you consider? Which diseases will be excluded and which ones no? Response: Thank you for your valuable comment. We have rewritten the exclusion criteria subsection of the manuscript according to your suggestions. Comment 3: Finally, to improve the rehabilitative aspects of this study, you should explain in the discussion how your results could add new options for chronic low back pain therapy and rehabilitation. Response: We appreciate the reviewer’s suggestion to clarify how our findings could contribute to rehabilitation strategies for chronic low back pain. In the revised discussion, we have emphasized the potential rehabilitative implications of our study. Specifically, we highlight that therapeutic exercise may not only reduce musculoskeletal pain and disability but also play a role in regulating vitamin D metabolism, thereby offering a novel mechanism for functional recovery. We further explain that lifestyle education, if effective, could promote self‑regulation of vitamin D3 levels and support natural remission of CLBP. Thank you. Competing Interests: No Close Report a concern COMMENT ON THIS REPORT Comments on this article Comments (0) Version 2 VERSION 2 PUBLISHED 21 Nov 2022 ADD YOUR COMMENT Comment keyboard_arrow_left keyboard_arrow_right Open Peer Review Reviewer Status info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Reviewer Reports Invited Reviewers 1 2 3 4 Version 2 (revision) 03 Mar 26 read read Version 1 21 Nov 22 read read Giacomo Farì , Aldo Moro University of Bari, Bari, Italy Gopal Nambi , Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia Spyridon Sotiropoulos , University of West Attica, Athens, Greece Mohammad Sidiq , Tishk International University, Erbil, Iraq Akansha Suman , Shri Guru Ram Rai University, Dehradun, India Comments on this article All Comments (0) Add a comment Sign up for content alerts Sign Up You are now signed up to receive this alert Browse by related subjects keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2026 Sidiq M et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 01 Apr 2026 | for Version 2 Mohammad Sidiq , Tishk International University, Erbil, Iraq Akansha Suman , Department of Physiotherapy, School of Paramedical & Allied Health Sciences, Shri Guru Ram Rai University, Dehradun, Uttarakhand, India 0 Views copyright © 2026 Sidiq M et al. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions I would like to appreciate authors for this proposed trial but it needs some amendments as under: This protocol outlines a randomized trial to compare the effectiveness of two intervention strategies to treat chronic low back pain (CLBP) in individuals with low vitamin D levels. The purposes of the trial are to compare the impact of therapeutic exercises in the context of either pain neuroscience education or vitamin D supplementation on pain, function, and other relevant outcomes of interest. The study protocol employs a randomized, assessor-blinded, multicenter, parallel-group design, which effectively addresses the research question. The research is of interest because of the high prevalence of CLBP and growing interest in both mind-related (education) and body-related (vitamin D) issues. The study addresses a significant gap, but there are areas where details of the study methodology and reporting need to be clarified for proper replication, reproduction, and rigor. Major Comments (Must Be Addressed) 1. Explanation of Research Gap The justification for the study is explained, but not why the research gap exists. Insufficient detail is provided in the manuscript on: • That evidence is insufficient • The contribution this new study makes compared to previous trials What's more, the objectives are not well prioritized: • The primary outcome must be identified • Secondary outcomes must be identified Recommendation: Make sure to clearly justify and identify novelty in the introduction. Separately state what is primary vs secondary 2. Sample Size The protocol is lacking a sound sample size calculation, which is an important design consideration. Recommendation: Include: • Estimated effect size (citation) • Power (typically 80–90%) • Alpha level • Estimated dropout rate • Estimated sample size 3. Methods of Randomization and Allocation Concealment Randomization is stated, but specific details are lacking, such as: • Randomization sequence generator (e.g., computer) • Mechanism used to conceal allocation (e.g., opaque sealed envelopes) Recommendation: Describe allocation of groups in detail and according to CONSORT to reduce bias in selection. 4. Interventions (To enable repetitive studies) General but little detail about the interventions: • Exercise type, intensity, progression and supervision • Pain neuroscience education content and format • Dose, frequency, duration and reason for vitamin D supplement • Adherence and compliance monitoring Recommendation: Include more detail on intervention using methods such as TIDieR 5. Statistical Analysis Plan The plan lacks sufficient specificity regarding the statistical analysis. • Approaches to missing data (e.g., intention-to-treat) • Adjustment for baseline covariates • Adjustment for baseline covariates • Subgroup or "post-hoc" analyses Recommendation: Offer a full statistical analysis plan for greater transparency. 6. Outcomes and timepoints Even though outcomes are discussed, the protocol does not include: • clear specification of a primary outcome measure • Tabulated display of timepoints for assessments • Rationale for choice of outcomes Recommendation: Provide a table that includes: • Primary and secondary outcomes • Measurement tools • Time (baseline, follow-up) You can also include MCID. Minor Comments (Should Be Addressed) 1. Blinding and Bias • The assessors were blinded • But participants cannot be blinded, and this introduces bias See discussion of performance and expectation bias. 2. Confounding Variables Potential confounders are not controlled for: • Sunlight exposure • Dietary vitamin D intake • Levels of physical activity Add measures to either control for these variables or plan for recording them. 3. Ethical Considerations Consent is sought, but: • Ensure safety monitoring is detailed for vitamin D supplements Include procedures for safety monitoring and adverse events 4. Trial Registration • Take care to ensure the trial number is clearly identified. 5. Language and Structure • Some grammatical improvements needed • Some improvements to be made for clarity Overall Recommendation Major Revision The protocol poses a relevant and timely clinical question, suitable for a randomized controlled evaluation. But important study details are missing, particularly in terms of sample size, study intervention, outcome measures, and statistical considerations. This is important to ensure the study is rigorously conducted, replicable, and meets international reporting guidelines. Is the rationale for, and objectives of, the study clearly described? Partly Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Partly Are the datasets clearly presented in a useable and accessible format? Not applicable Competing Interests No competing interests were disclosed. Reviewer Expertise Musculoskeletal, Pain Sciences and Public Health We confirm that we have read this submission and believe that we have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however we have significant reservations, as outlined above. reply Respond to this report Responses (0) Sidiq M and Suman A. Peer Review Report For: Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.5256/f1000research.196043.r466508) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/11-1352/v2#referee-response-466508 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2026 Sotiropoulos S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 25 Mar 2026 | for Version 2 Spyridon Sotiropoulos , University of West Attica, Athens, Greece 0 Views copyright © 2026 Sotiropoulos S. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (0) Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This manuscript presents a study protocol for a two-arm, assessor-blinded randomized clinical trial investigating the additional effect of vitamin D3 supplementation compared with an educational booklet when combined with therapeutic exercise in individuals with chronic low back pain and vitamin D deficiency. The topic is clinically relevant, given the high prevalence of both low back pain and hypovitaminosis D, and the growing interest in multimodal management strategies. The rationale and objectives are clearly described. The authors provide a coherent background linking vitamin D deficiency with musculoskeletal pain, and they articulate a clear hypothesis alongside well-defined primary and secondary objectives. Although the background appropriately acknowledges that existing evidence is mixed, some statements may still lean toward overstating the potential benefits of vitamin D supplementation. Nonetheless, the justification for conducting the trial is reasonable and clearly presented. The overall study design—a randomized, assessor-blinded trial—is appropriate for the research question and reflects a pragmatic approach consistent with physiotherapy practice. However, a key methodological concern remains insufficiently addressed. The allocation of different intervention arms to separate centers introduces a risk of confounding between treatment and study site. Differences in patient populations, clinician behavior, or contextual factors across centers may influence outcomes independently of the intervention. While the authors note stratification by study center, this approach does not fully resolve the issue if intervention and center are structurally linked. The manuscript would be strengthened by explicitly describing how site effects will be accounted for in the statistical analysis (e.g., inclusion as a fixed or random effect) or by providing a stronger justification for this design choice. The methods are described in substantial detail and are generally sufficient to support replication. Eligibility criteria, intervention protocols, outcome measures, and timelines are clearly specified. The inclusion of assessor and data analyst blinding is a strength. Adherence to interventions is addressed through the use of medication charts and exercise checklists, and adverse events are monitored systematically. The statistical analysis plan is also well developed, including intention-to-treat principles, appropriate modeling approaches, and reporting of effect sizes. However, further clarification on the handling of site-related effects within the analysis would improve methodological transparency. As expected for a study protocol, no dataset is presented. The authors provide comprehensive supporting materials, including checklists, consent forms, and trial documentation, which enhances transparency and reproducibility. A brief statement outlining how and when the final dataset will be shared would further strengthen alignment with open science practices. In summary, this is a well-structured and clinically relevant protocol with generally strong methodological detail. The primary issue requiring attention is the potential for center-related confounding due to the allocation of interventions across sites. Addressing this concern would strengthen the internal validity of the study. Secondary improvements relate to clarifying data-sharing plans. These issues are addressable and do not fundamentally undermine the overall study design. Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Yes Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise Musculoskeletal physiotherapy, chronic low back pain, exercise therapy, non-pharmacological interventions, clinical trial methodology and rehabilitation research. I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard. reply Respond to this report Responses (0) Sotiropoulos S. Peer Review Report For: Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.5256/f1000research.196043.r464590) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/11-1352/v2#referee-response-464590 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2023 Nambi G. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 29 Jun 2023 | for Version 1 Gopal Nambi , Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, Saudi Arabia 0 Views copyright © 2023 Nambi G. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Not Approved info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions Dear Authors Thanks a lot for the opportunity you have offered me to revise the fascinating manuscript, "Comparison of the effects of therapeutic exercise...randomized clinical trial". I thank the authors for their effort in producing this exciting manuscript. From the editing point of view, I recommend the authors to fully respect the editing requirements imposed by this scientific journal and clearly indicated in the template. More specifically, I mean: the number of words in the abstract and manuscript, the number of keywords and the way to indicate the bibliographic sources. As a significant strength: This proposal is a novelty in the field and adds information to the existing evidence in the literature produced in the field. As a major weakness: The manuscript lacks details and clarity concerning methodological steps that would help improve the understanding of the manuscript. Keywords: use MeSH keywords Abstract: The background of the study talks only about CLBP. The objective of the study is not clear. Mention the study duration and study setting. Mention the character of the study participants. Mention the treatment procedure in short. Mention the outcome measures in short and its duration of measurement. Mention the statistical tests used for the study. Manuscript Mention the acronym of abbreviation when it is used for the first time. Please recheck the reference number 5. Mention the relation between CLBP and vitamin D deficiency in detail. Mention in detail about Vit D supplement, its role, merits and demerits in CLBP. How come this study is differing from the reference study 10? Mention the gaps monitored by the researcher in the previous studies. Mention the study hypothesis. Include the clinical significance of this study over clinicians, patients, and researchers after the study hypothesis. Mention who has diagnosed the participants and their qualification and experience. Mention the detail information about randomization, allocation and blinding. Mention in detail about the exercise protocol and the contents involved in booklet. Mention the outcome measures measured in the study and its reliability and validity. Mention the sample size calculation with reference. The information provided is not sufficient. Mention the statistical tests included in the study. The tests mentioned are not suitable. Is the rationale for, and objectives of, the study clearly described? No Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? No Are the datasets clearly presented in a useable and accessible format? Partly Competing Interests No competing interests were disclosed. Reviewer Expertise Musculoskeletal and sports physiotherapy I confirm that I have read this submission and believe that I have an appropriate level of expertise to state that I do not consider it to be of an acceptable scientific standard, for reasons outlined above. reply Respond to this report Responses (1) Author Response 03 Mar 2026 Dr. Kazi Md. Amran Hossain, PT, Department of Physiotherapy & Rehabilitation, Jashore University of Science & Technology, Jashore, 7408, Bangladesh Reviewer 2 Comment 1: From the editing point of view, I recommend the authors to fully respect the editing requirements imposed by this scientific journal and clearly indicated in the template. More specifically, I mean: the number of words in the abstract and manuscript, the number of keywords and the way to indicate the bibliographic sources. Response: We thank the reviewer for this valuable observation and have carefully revised the manuscript to ensure full compliance with the journal’s editorial requirements. The abstract has been shortened to meet the word limit, the number of keywords has been adjusted according to the journal’s specifications, and all bibliographic references have been reformatted to strictly follow the prescribed citation style. In addition, we verified that the overall manuscript length now falls within the required limits. We believe these revisions address the reviewer’s concern and ensure that the manuscript fully respects the journal’s formatting and editing standards. Comment 2: As a significant strength: This proposal is a novelty in the field and adds information to the existing evidence in the literature produced in the field. Response: We sincerely appreciate the reviewer’s recognition of the novelty and contribution of our proposal. We agree that the study introduces an innovative perspective in the field and adds valuable information to the existing body of evidence. By addressing current gaps and integrating findings with the broader literature, we believe our work strengthens the scientific understanding and provides meaningful insights that can guide future research and clinical practice. Comment 3: As a major weakness: The manuscript lacks details and clarity concerning methodological steps that would help improve the understanding of the manuscript. Response: We thank the reviewer for this constructive observation and acknowledge the importance of providing clear methodological details to enhance the transparency and reproducibility of our work. In the revised manuscript, we have expanded the description of the methodological steps, including participant selection criteria, intervention procedures, outcome measures, and statistical analyses. These additions aim to improve clarity and allow readers to better understand the study design and implementation. We believe that the revisions now address the reviewer’s concern and strengthen the methodological rigor and comprehensibility of the manuscript. Comment 4: Keywords: use MeSH keywords Abstract: The background of the study talks only about CLBP. The objective of the study is not clear. Mention the study duration and study setting. Mention the character of the study participants. Mention the treatment procedure in short. Mention the outcome measures in short and its duration of measurement. Mention the statistical tests used for the study. Response: We thank the reviewer for these constructive suggestions regarding the abstract and keywords. In the revised manuscript, we have replaced the keywords with appropriate MeSH terms to ensure consistency with indexing standards. The abstract has been thoroughly revised to provide a clearer and more comprehensive overview of the study. Specifically, the background now contextualizes the research beyond chronic low back pain (CLBP), the study objective has been explicitly stated, and details regarding the study duration and setting have been included. We have also described the characteristics of the study participants, summarized the treatment procedure, and briefly outlined the outcome measures along with the timing of their assessment. Finally, the statistical tests employed in the analysis have been mentioned to enhance transparency. We believe these revisions improve the clarity and completeness of the abstract and align it more closely with the journal’s requirements. Comment 5: How come this study is differing from the reference study 10? Response: We appreciate the reviewer’s observation regarding the differences between our study and Reference 10. The study by Ali et al. (2021) investigated the combined effect of vitamin D supplementation and physiotherapy in patients with musculoskeletal disorders using a quasi-experimental design. In contrast, our study specifically focuses on chronic low back pain and employs a randomized, assessor-blinded, multicenter clinical trial design to compare the effects of therapeutic exercise when combined either with an educational booklet or with vitamin D3 supplementation. Thus, while both studies examine the role of vitamin D in musculoskeletal pain, our trial differs in its methodological rigor, target population, and intervention comparison, aiming to provide higher-level evidence on the relative effectiveness of exercise combined with different adjuncts in CLBP management. Comment 6: Mention the gaps monitored by the researcher in the previous studies. Mention the study hypothesis. Include the clinical significance of this study over clinicians, patients, and researchers after the study hypothesis. Mention who has diagnosed the participants and their qualification and experience. Mention the detail information about randomization, allocation and blinding. Mention in detail about the exercise protocol and the contents involved in booklet. Mention the outcome measures measured in the study and its reliability and validity. Mention the sample size calculation with reference. The information provided is not sufficient. Mention the statistical tests included in the study. The tests mentioned are not suitable. Response: We thank the reviewer for these constructive suggestions. In the revised manuscript, we addressed the issues throughout the manuscript. Thank you. View more View less Competing Interests No competing interest. reply Respond Report a concern Nambi G. Peer Review Report For: Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.5256/f1000research.140494.r181246) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/11-1352/v1#referee-response-181246 keyboard_arrow_left Back to all reports Reviewer Report 0 Views copyright © 2023 Farì G. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. 28 Jun 2023 | for Version 1 Giacomo Farì , Department of Basic Sciences, Neuroscience and Sense Organs, Aldo Moro University of Bari, Bari, Italy 0 Views copyright © 2023 Farì G. This is an open access peer review report distributed under the terms of the Creative Commons Attribution License , which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. format_quote Cite this report speaker_notes Responses (1) Approved With Reservations info_outline Alongside their report, reviewers assign a status to the article: Approved The paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. Not approved Fundamental flaws in the paper seriously undermine the findings and conclusions This protocol is interesting and in line with the aims of this journal. Some concerns have to be addressed. I really appreciate that you provided the clinical trial registration and the IRB approval, but it is still not clear if this study will be a prospective or a retrospective one? Then, since you compare three interventions, very different from each other, you should better define the inclusion/exclusion criteria: which Low back pain will you consider? Which diseases will be excluded and which ones no? Finally, to improve the rehabilitative lapels of this study, you should explain in the discussion how your results could add new options for chronic low back pain therapy and rehabilitation. Best regards and good luck Is the rationale for, and objectives of, the study clearly described? Yes Is the study design appropriate for the research question? Partly Are sufficient details of the methods provided to allow replication by others? Yes Are the datasets clearly presented in a useable and accessible format? Yes Competing Interests No competing interests were disclosed. Reviewer Expertise rehabilitation I confirm that I have read this submission and believe that I have an appropriate level of expertise to confirm that it is of an acceptable scientific standard, however I have significant reservations, as outlined above. reply Respond to this report Responses (1) Author Response 03 Mar 2026 Dr. Kazi Md. Amran Hossain, PT, Department of Physiotherapy & Rehabilitation, Jashore University of Science & Technology, Jashore, 7408, Bangladesh Reviewer 1 This protocol is interesting and in line with the aims of this journal. Some concerns have to be addressed. Comment 1: I really appreciate that you provided the clinical trial registration and the IRB approval, but it is still not clear if this study will be a prospective or a retrospective one? Response: Thank you for your valuable comment. It is indeed a prospective study. I have completed the baseline and post intervention data collection now we are collecting the follow-up information of the participants. Comment 2: Then, since you compare three interventions, very different from each other, you should better define the inclusion/exclusion criteria: which Low back pain will you consider? Which diseases will be excluded and which ones no? Response: Thank you for your valuable comment. We have rewritten the exclusion criteria subsection of the manuscript according to your suggestions. Comment 3: Finally, to improve the rehabilitative aspects of this study, you should explain in the discussion how your results could add new options for chronic low back pain therapy and rehabilitation. Response: We appreciate the reviewer’s suggestion to clarify how our findings could contribute to rehabilitation strategies for chronic low back pain. In the revised discussion, we have emphasized the potential rehabilitative implications of our study. Specifically, we highlight that therapeutic exercise may not only reduce musculoskeletal pain and disability but also play a role in regulating vitamin D metabolism, thereby offering a novel mechanism for functional recovery. We further explain that lifestyle education, if effective, could promote self‑regulation of vitamin D3 levels and support natural remission of CLBP. Thank you. View more View less Competing Interests No reply Respond Report a concern Farì G. Peer Review Report For: Comparison of the effects of therapeutic exercise with either an educational booklet or vitamin-D3 supplement in the management of chronic low back pain: study protocol for an assessor blinded multicenter randomized clinical trial [version 2; peer review: 1 approved, 2 approved with reservations, 1 not approved] . F1000Research 2026, 11 :1352 ( https://doi.org/10.5256/f1000research.140494.r181251) NOTE: it is important to ensure the information in square brackets after the title is included in this citation. The direct URL for this report is: https://f1000research.com/articles/11-1352/v1#referee-response-181251 Alongside their report, reviewers assign a status to the article: Approved - the paper is scientifically sound in its current form and only minor, if any, improvements are suggested Approved with reservations - A number of small changes, sometimes more significant revisions are required to address specific details and improve the papers academic merit. 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