PONE-D-21-22065

Motor control exercises versus general exercises for greater trochanteric pain syndrome: A protocol of a randomized controlled trial

PLOS ONE

Dear Dr. Thomaz de Aquino Nava,

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.

The manuscript has been evaluated by three reviewers, and their comments are available below.

The reviewers have raised a number of concerns that need attention. They request additional information regarding the planned consent method and clarification on the primary and/or secondary aspects for this study. The reviewers also request more information regarding the methodological aspects of the study (such as the planned statistical analysis)

Could you please revise the manuscript to carefully address the concerns raised?

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Jamie Royle, PhD

Associate Editor

PLOS ONE

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“This study was financed by the Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, Brasil (CAPES)—Doctorate’s degree scholarship, Finance Code 001.”

We note that you have provided funding information that is not currently declared in your Funding Statement. However, 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 and let us know how you would like to update your Funding Statement. Currently, your Funding Statement reads as follows:

“GTAN (Finance Code 001): Coordenação de Aperfeiçoamento de Pessoal de Nível Superior, Brasil (CAPES) - Doctorate’s degree scholarship.

https://www.gov.br/capes/pt-br

The funders had and will not have a role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.”

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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?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: 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?

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

********** 

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

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

********** 

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

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: No

Reviewer #2: Yes

Reviewer #3: Yes

********** 

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

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

********** 

6. Review Comments to the Author

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.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Motor control exercises versus general exercises for greater trochanteric pain syndrome: A protocol of a randomized controlled trial

-I find this a very interesting topic, thank you for addressing the pain of the greater trochanteric region in this study.

-I am going to make a series of recommendations to make them clearer for the reader.

-It is advisable not to use abbreviations in the abstract.

-Line 146- when they talk "the second one will be carried out by a blinded-assessor", it is not clear what this assessor is doing in this sentence. In fact it is not clear from the manuscript what this evaluator does. Please clarify what tasks this evaluator does in the manuscript, as it is not clear, nor how many times he/she evaluates the subject (line 211).

-At what point do the participants sign the informed consent, according to the Randomization, allocation and blinding section, is when they are going to receive the intervention program. The informed consent should be signed at the moment that the subjects want to participate once they have been thoroughly explained what the study consists of.

-Review bibliography number 28, it does not follow the format.

I hope that with these clarifications you can publish your protocol.

Reviewer #2: The authors plan to enroll 60 participant to conduct a two-arm, parallel randomized, double-blinded trial to compare the effect of general exercises v.s. a motor control training on pain at baseline and after treatment in women with greater trochanteric pain syndrome (GTPS).

1. Line 197. “effect size of 0,5” Please clarify whether this is in standard deviation unit? If not, what standard deviation was used in this power analysis.

2. Line 370. “appropriate statistical analyses will be adopted for the variables”. Please be specific for “appropriate statistical analyses”.

3. Line 377. “A causal mediation analysis will be conducted..” please be specific what mediation analysis will be conducted.

Reviewer #3: 1.) I am pleased to see the VISA-G outcome tool is mentioned within this protocol to improve homogenous outcome measures within GTPS research. However, it is unclear why this is not included as an outcome within the protocol submitted after ethical approval of the original document. It is unclear if the VISA-G is to be used as an outcome measure or not. If it is, please add this into either the primary or secondary outcomes. If it is not to be used as an outcome measure, why not? This has been previously recommended to be used in GTPS research to improve outcome homogeneity.

2.) You have stated that greater tochanteric palpation in conjunction with one other test will be used. It would be informative to state that this is because GT palp is of little benefit when the test is positive due to the poor Sp. Therefore, in the absence of a negative GT palp test, another test with high Sp will be used to rule in the pathology of interest (GTPS) to reduce your false positive inclusion rate.

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7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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Motor control exercises versus general exercises for greater trochanteric pain syndrome: A protocol of a randomized controlled trial

PONE-D-21-22065R1

Dear Dr. Thomaz de Aquino Nava,

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,

George Vousden

Staff Editor

PLOS ONE

Additional Editor Comments (optional):

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?

The research question outlined is expected to address a valid academic problem or topic and contribute to the base of knowledge in the field.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

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

The manuscript should describe the methods in sufficient detail to prevent undisclosed flexibility in the experimental procedure or analysis pipeline, including sufficient outcome-neutral conditions (e.g. necessary controls, absence of floor or ceiling effects) to test the proposed hypotheses and a statistical power analysis where applicable. As there may be aspects of the methodology and analysis which can only be refined once the work is undertaken, authors should outline potential assumptions and explicitly describe what aspects of the proposed analyses, if any, are exploratory.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

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

Descriptions of methods and materials in the protocol should be reported in sufficient detail for another researcher to reproduce all experiments and analyses. The protocol should describe the appropriate controls, sample size calculations, and replication needed to ensure that the data are robust and reproducible.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

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

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception, at the time of publication. The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

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

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

6. Review Comments to the Author

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.

(Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: Thank you for correcting and adapting all the corrections in the manuscript. For my part I have no more appreciations to include in your manuscript to be published.

Best regards

Reviewer #2: Thank you. All previously raised comments have been successfully addressed. I have no further comments

Reviewer #3: Thank you for making the suggested changes to the manuscript. I have no further comments to make regarding the manuscript.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: No

Reviewer #3: No