Dear Dr. Hahne 

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

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• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
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We look forward to receiving your revised manuscript.

Kind regards,

Mansour Abdullah Alshehri

Academic Editor

PLOS ONE

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When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at 

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and 

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

2. We noticed you have some minor occurrence of overlapping text with the following previous publication(s), which needs to be addressed:

https://www.sciencedirect.com/science/article/abs/pii/S1551714425001545?via%3Dihub

In your revision ensure you cite all your sources (including your own works), and quote or rephrase any duplicated text outside the methods section. Further consideration is dependent on these concerns being addressed.

3. Thank you for stating the following financial disclosure: 

“JSS College of Physiotherapy funded the fMRI scans and physiotherapy treatment.”

Please state what role the funders took in the study.  If the funders had no role, please state: "The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript." If this statement is not correct you must amend it as needed. 

Please include this amended Role of Funder statement in your cover letter; we will change the online submission form on your behalf.

4. Please note that funding information should not appear in the Acknowledgments section or other areas of your manuscript. We will only publish funding information present in the Funding Statement section of the online submission form. Please remove any funding-related text from the manuscript. 

5. If the reviewer comments include a recommendation to cite specific previously published works, please review and evaluate these publications to determine whether they are relevant and should be cited. There is no requirement to cite these works unless the editor has indicated otherwise. 

6. Please review your reference list to ensure that it is complete and correct. If you have cited papers that have been retracted, please include the rationale for doing so in the manuscript text, or remove these references and replace them with relevant current references. Any changes to the reference list should be mentioned in the rebuttal letter that accompanies your revised manuscript. If you need to cite a retracted article, indicate the article’s retracted status in the References list and also include a citation and full reference for the retraction notice.

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Does the manuscript provide a valid rationale for the proposed study, with clearly identified and justified research questions?

Reviewer #1: Yes

Reviewer #2: Yes

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2. Is the protocol technically sound and planned in a manner that will lead to a meaningful outcome and allow testing the stated hypotheses??>

Reviewer #1: Yes

Reviewer #2: Yes

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3. Is the methodology feasible and described in sufficient detail to allow the work to be replicable??>

Reviewer #1: Yes

Reviewer #2: Yes

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4. Have the authors described where all data underlying the findings will be made available when the study is complete??>

The PLOS Data policy

Reviewer #1: Yes

Reviewer #2: Yes

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5. Is the manuscript presented in an intelligible fashion and written in standard English??>

Reviewer #1: Yes

Reviewer #2: Yes

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Please use the space provided to explain your answers to the questions above and, if applicable, provide comments about issues authors must address before this protocol can be accepted for publication. You may also include additional comments for the author, including concerns about research or publication ethics.

You may also provide optional suggestions and comments to authors that they might find helpful in planning their study.

Reviewer #1: Comments

General comments: This is a well-written protocol that largely follows rigorous statistical analytic techniques for assessing the effectiveness of STOPS. The cost-effectiveness analysis and qualitative aspect are quite detailed and well written. Here are a few comments

1. State the type of trial being conducted (superiority, non-inferiority, equivalence)

2. Clearly state the hypothesis the hypothesis to be tested based on the type of trial being conducted

3. The authors indicated that all participants would receive 10 x 45-minute physiotherapy sessions throughout 10 weeks, but did not provide any justification for the intervention period and its implications. Why 10 weeks? For instance, does extending the period beyond 10 weeks change the effect of the intervention (positive or negative)? What would have been the implication (positive or negative) if a shorter duration had been chosen? Details must be provided

4. Separate the power analysis (sample size calculations) from the data analysis section. There should be separate subheadings for sample size (power analysis) and statistical analysis to aid the flow of the protocol. The sample size estimation must be based on a clearly defined hypothesis and the type of RCT, as stated previously. There should be a section on data quality assurance for the trial.

5. Kindly include the key assumptions under linear mixed-effects models and how these assumptions will be tested. Include regression modelling strategies that will be adopted if these assumptions are violated

6. The authors stated that “For ordinal outcomes, the Mann-Whitney U test will be used,” but did not indicate what the test would be used for. The statement is not complete

7. The statement “Dichotomous outcomes will be presented using risk ratios and the number needed to treat (with associated 95% confidence intervals), with significance determined using chi-square (χ²) analyses.” is unclear and somewhat confusing. Please revise and specify when you will use the Chi-square test and break sentences to make it a bit clearer.

8. The authors did not mention the statistical tool for mediation analysis. This must be included in the manuscript.

9. The authors did not include the statistical tool for assessing effect modification. Thy only mentioned the effect modifiers. This must be included in the manuscript.

Reviewer #2: 1.In exclusion criteria they mentioned minimal physical activity limitation will be excluded. From my point there is no need to mention it rather than mention the minimal physical activity limitation criteria like can sit more than 1 hour without pain etc.

2. Usual Care: Description of usual care should be included

3. Who will be the treatment provider: You mentioned only 2 PT trained about STOP approach. Is it possible to serve only by them.

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Reviewer #1: No

Reviewer #2: Yes:  Md. Zahid Hossain

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STOPS approach to individualised physiotherapy versus usual physiotherapy care for chronic low back pain in India: A randomised controlled trial protocol

PONE-D-25-44126R1

Dear Dr. Hahne,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

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Kind regards,

Mansour Abdullah Alshehri

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Reviewers' comments: