{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,5,5]],"date-time":"2026-05-05T12:32:15Z","timestamp":1777984335008,"version":"3.51.4"},"update-to":[{"DOI":"10.12688\/f1000research.127948.1","type":"new_version","label":"New version","source":"publisher","updated":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T00:00:00Z","timestamp":1772496000000}}],"reference-count":37,"publisher":"F1000 Research Ltd","license":[{"start":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T00:00:00Z","timestamp":1772496000000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"N\/A"}],"content-domain":{"domain":["f1000research.com"],"crossmark-restriction":false},"short-container-title":["F1000Res"],"abstract":"\n Background<\/ns7:bold>\n : 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.\n Methods<\/ns7:bold>\n : 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\u201365 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.\n Discussion<\/ns7:bold>\n : 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 (\n CTRI\/2022\/11\/047074<\/ns7:ext-link>\n ).\n <\/ns7:p>","DOI":"10.12688\/f1000research.127948.2","type":"journal-article","created":{"date-parts":[[2026,3,3]],"date-time":"2026-03-03T10:19:10Z","timestamp":1772533150000},"page":"1352","update-policy":"https:\/\/doi.org\/10.12688\/f1000research.crossmark-policy","source":"Crossref","is-referenced-by-count":0,"title":["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"],"prefix":"10.12688","volume":"11","author":[{"given":"Muhammad Shahidul","family":"Islam","sequence":"first","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2124-2087","authenticated-orcid":false,"given":"K. M. Amran","family":"Hossain","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Md. Sohrab","family":"Hossain","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Rashida","family":"Parvin","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0003-2618-4461","authenticated-orcid":false,"given":"Nadia Afrin","family":"Urme","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Veena","family":"Raigangar","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Iqbal Kabir","family":"Jahid","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"ORCID":"https:\/\/orcid.org\/0000-0002-5885-4514","authenticated-orcid":false,"given":"Md. Feroz","family":"Kabir","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]},{"given":"Md. Ashrafuzzaman","family":"Zahid","sequence":"additional","affiliation":[],"role":[{"role":"author","vocabulary":"crossref"}]}],"member":"2560","published-online":{"date-parts":[[2026,3,3]]},"reference":[{"key":"ref1","doi-asserted-by":"crossref","first-page":"1-4","DOI":"10.1186\/1471-2474-15-50","article-title":"A systematic review and meta-synthesis of the impact of low back pain on people\u2019s lives.","volume":"15","author":"R Froud","year":"2014","journal-title":"BMC Musculoskelet. 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Amran Hossain, PT<\/b>; \nPosted: 31 Jan 2026<\/i>; \nReviewer 1<\/b> This protocol is interesting and in line with the aims of this journal. Some concerns have to be addressed. \nComment 1: <\/b>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? \nResponse:<\/b> 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.  \nComment 2:<\/b> 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? \nResponse:<\/b> Thank you for your valuable comment. We have rewritten the exclusion criteria subsection of the manuscript according to your suggestions. \nComment 3:<\/b> 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. \nResponse:<\/b> We appreciate the reviewer\u2019s 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\u2011regulation of vitamin D3 levels and support natural remission of CLBP. Thank you.","URL":"https:\/\/f1000research.com\/articles\/11-1352\/v2#referee-comment-15373","order":1,"name":"referee-comment-15373","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.5256\/f1000research.140494.r181246, Gopal Nambi, Department of Health and Rehabilitation Sciences, College of Applied Medical Sciences, Prince Sattam Bin Abdulaziz University, Alkharj, 29 Jun 2023, version 1, 1 approved with reservations, 1 not approved","URL":"https:\/\/f1000research.com\/articles\/11-1352\/v1#referee-response-181246","order":2,"name":"referee-response-181246","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"Dr. Kazi Md. Amran Hossain, PT<\/b>; \nPosted: 31 Jan 2026<\/i>; \nReviewer 2<\/b> \nComment 1:<\/b> 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. \nResponse:<\/b> We thank the reviewer for this valuable observation and have carefully revised the manuscript to ensure full compliance with the journal\u2019s editorial requirements. The abstract has been shortened to meet the word limit, the number of keywords has been adjusted according to the journal\u2019s 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\u2019s concern and ensure that the manuscript fully respects the journal\u2019s formatting and editing standards. \nComment 2:<\/b> 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. \nResponse:<\/b> We sincerely appreciate the reviewer\u2019s 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. \nComment 3: <\/b>As a major weakness: The manuscript lacks details and clarity concerning methodological steps that would help improve the understanding of the manuscript. \nResponse:<\/b> 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\u2019s concern and strengthen the methodological rigor and comprehensibility of the manuscript. \nComment 4: <\/b> 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. \nResponse: <\/b>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\u2019s requirements. \nComment 5: <\/b>How come this study is differing from the reference study 10? \nResponse: <\/b>We appreciate the reviewer\u2019s 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. \nComment 6: <\/b> 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. \nResponse:<\/b> We thank the reviewer for these constructive suggestions. In the revised manuscript, we addressed the issues throughout the manuscript. Thank you.","URL":"https:\/\/f1000research.com\/articles\/11-1352\/v2#referee-comment-15374","order":3,"name":"referee-comment-15374","label":"Referee Comment","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.5256\/f1000research.196043.r464590, Spyridon Sotiropoulos, University of West Attica, Athens, 25 Mar 2026, version 2, indexed","URL":"https:\/\/f1000research.com\/articles\/11-1352\/v2#referee-response-464590","order":4,"name":"referee-response-464590","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"10.5256\/f1000research.196043.r466508, Mohammad Sidiq, Akansha Suman, Tishk International University, Erbil, 01 Apr 2026, version 2, indexed","URL":"https:\/\/f1000research.com\/articles\/11-1352\/v2#referee-response-466508","order":5,"name":"referee-response-466508","label":"Referee Report","group":{"name":"article-reports","label":"Article Reports"}},{"value":"The author(s) declared that no grants were involved in supporting this work","order":6,"name":"grant-information","label":"Grant Information"},{"value":"This is an open access article distributed under the terms of the Creative Commons Attribution Licence, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.","order":0,"name":"copyright-info","label":"Copyright"}]}}