PONE-D-23-12627Pragmatic effects of spinal thrust manipulations on pain parameters: cervical spine versus thoracic spine in Cervicogenic headache – A prospective, single-blinded, randomized controlled study.PLOS ONE

Dear Dr. Nambi,

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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We look forward to receiving your revised manuscript.

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Jianhong Zhou

Staff Editor

PLOS ONE

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Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Yes

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2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

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3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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

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4. 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: No

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: This is an interesting study and the protocol looks sound, however, the manipulation techniques, as described, do not look sound at all. Not contemporary manual therapy practice.

See my comments in the pdf file.

With some major revisions, this could be a great paper for publication.

Reviewer #2: This was a novel study that gives first evidence for a difference between cervical and thoracic manipulation for cervicogenic headache, as well as an advantage for manipulation over massage used in conventional physical therapy. On the whole, the study is well designed with appropriate. primary and secondary outcomes for CGH. There was excellent adherence to care and compliance with data collection.

There are some limitations that need to be considered. The sample size was small albeit the study was powered. The standard for headache outcomes is a headache diary that uses technology to ensure that frequency and pain intensity are reported immediately on the day stipulated, not added in later. Also, the conventional physical therapy intervention appears to have visits of longer duration than the manipulation visits which could have introduced attention bias and reduced treatment effect estimates. The manuscript needs work. More details and language editing are required.

Title:

1. Try “Comparative effectiveness of cervical vs thoracic spinal-thrust manipulation for care of cervicogenic headache: a randomized controlled trial”

Introduction

2. 1st paragraph: Give a citation for CGH having socioeconomic impact and being a significant public health burden.

3. Reference 13: This was a pilot study. A full-scale RCT on dose-response was published in 2018 in The Spine Journal. This would be a better reference.

Material and Methods

4. Design: Blinding: This study was not “single blind.” This designation would require that the participant or provider was blinded. The assessor was blinded for data collection, but for the primary outcome the assessor was the participant, so the study cannot properly be called assessor-blind either.

5. Participants: Include a reference for CONSORT.

6. Interventions: State that all three groups received ten minutes of hydrocollator heat prior to intervention (manipulation or massage).

7. Spinal Manipulation Therapy:

Include the reference number for “Peterson and Bergman.”

Was a “cracking” sound required for the manipulation to be considered successful?

8. Cervical Manipulation: Were multiple segment-specific manipulations permitted on each side based on segmental dysfunction or was a single general, nonspecific manipulation performed on each side?

9. CGH Disability: Briefly explain how the HIT questionnaire is scored: scale for each of the six items and direction of scoring, totaling the score, and total scale range.

10. Sample size: Why was a four day’s difference between groups in CGH frequency chosen for the sample size calculation? Is this a clinically important difference between groups?

11. Analysis: Baseline comparisons:

Baseline statistical comparisons should not be performed. This is because in a randomized trial, baseline group differences are attributable to chance by definition, due to random allocation of participants. Remove baseline comparisons from text and tables.

12. Analysis: LMM: Further explain the model used. Was this a random-intercept model? If appropriate, identify which covariance structure was used.

13. Analysis: Post hoc analysis: Include here that post hoc Bonferroni analysis was use following the omnibus 3x4 LMM model to compare the three study groups pair-wise.

14. Analysis: Intention-to-Treat:

Include this under Analysis, not Results Participants.

Explain how you define intention-to treat because there are different definitions. Were participants with missing follow-up data included in the analysis?

Results

15. Participants:

Baseline characteristics: Make a general statement that the three groups were uniform in baseline characteristics and baseline outcome variables.

CGH was defined as unilateral, yet there were participants with bilateral headache. Explain why these were included?

16. Partial eta-squared: Remove this statistic from the text and tables. This effect size statistic is uncommon in biomedical research (usually found in the social sciences literature). It is also not defined or interpreted in this manuscript, so has no use.

17. Table 2: Show score range for NDI (0-100 with 100 worst) and EQ-5D (0-100 with 100 best) in the second column.

18. Table 3: CGH frequency: There are errors in the p-values for CSM x CPT at 8 weeks and 6 months.

Discussion

19. Organization: I suggest you start by stating this is the first powered study to compare cervical and thoracic manipulation for CGH and that the study shows that cervical manipulation was superior to thoracic manipulation and conventional PT (massage). Then compare studies and speculate about mechanisms.

20. 2nd Paragraph: This paragraph is confusing.

Statistically significant changes: This means a within-groups analysis of change over time. No within-groups analysis is identified under Methods or reported under Results. I think you are talking about between groups differences in improvement favoring CSM over TSM and CPT.

You report mean differences between groups from Table 3, not MCID. You can say that the differences between groups are clinically important, if you can give references that supports such claims. Also, start with the primary outcome, CGH frequency. Then discuss pain.

This study did not investigate thrust duration. You do not know if the thrust is less than 2ms in this study.

Perhaps change this paragraph into two separate paragraphs: one discussing clinical outcomes and the second discussing mechanism and theory.

21. Limitations: Differences in the length of study visits between groups adds attention bias and could reduce differences between manipulation groups and the massage group.

Conclusion

22. The conclusion in the abstract is more accurate and better written. You can use it again here and add a sentence or so to recommend a future research trajectory.

23. Strong evidence: This is a technical term used in systematic reviews. Strong evidence usually means multiple, high-quality trials with similar results.

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6. 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.

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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: Yes: Emilio "Louie" Puentedura

Reviewer #2: No

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Attachments

Attachment

Submitted filename: PONE-D-23-12627.pdf

PONE-D-23-12627R1Comparative effectiveness of cervical vs thoracic spinal-thrust manipulation for care of cervicogenic headache: a randomized controlled trial.PLOS ONE

Dear Dr. Nambi,

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.

Please submit your revised manuscript by Jan 14 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• 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'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

André Pontes-Silva

Academic Editor

PLOS ONE

Additional Editor Comments:

Journal: PLOS ONE.

Title: Comparative effectiveness of cervical vs thoracic spinal-thrust manipulation for care of cervicogenic headache: a randomized controlled trial.

ID: PONE-D-23-12627R1.

Dear authors, thank you for your answers. You have compared the clinical effects of cervical over thoracic spine manipulation and conventional physiotherapy in patients with CgH. Please, when you review the article, in addition to highlighting the helped text, you must inform the page (and lines) of each of the adjustments. This will help you to get an opinion quickly.

—Regarding minimum clinically important difference (MCID), please report the MCID for each of your outcomes and report it in the results. Outcomes that do not have an MCID established in the literature should be highlighted in the study limitations.

—Please report the effect size value for all comparisons performed—the p-value does not indicate clinical significance (https://pubmed.ncbi.nlm.nih.gov/36325112/). You should calculate the effect size using Cohen's d-value for quantitative variables; and using Cohen's w-value for % (use this online calculator: https://www.psychometrica.de/effect_size.html). By the way, this article may help you classify d and w values of the effect size: https://pubmed.ncbi.nlm.nih.gov/37971135/.

—Table 1: The reported p-value refers to which comparison? This table needs to present 3 p-values; where are they? First p-value: CSM x TSM; Second p-value: CSM x CPT; third p-value: TSM x CPT. Remember to also report the effect size for each of these comparisons. Furthermore, correct the terms weight (the correct term is body mass [kg]) and height (the correct term is stature [cm or m]).

—Table 2: The p-value reported refers to which comparison (CSM x TSM, CSM x CPT, TSM x CPT)? This table also needs to present 3 p-values; where are they? In the legend you must detail the information in the table, inform the tests that generated the p-value, and the alpha established for statistical significance. Tables must be intuitive (remember to also inform the effect size for each of these comparisons).

—Table 3: In addition to the p-value, report the effect size for each of these comparisons.

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: (No Response)

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2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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

**********

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: No

Reviewer #2: No

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: While most of the comments have been adequately addressed. There are still some concerns. Please see attached pdf file. Also, the images of the CSM and TSM are not great. Cringe level = 8/10.

Reviewer #2: This manuscript has been greatly improved by the authors.

In the process, however, several changes that the authors said they made are missing from the revised manuscript.

I also make some suggestions for language improvements to the revisions in the Discussion and Conclusions.

Material and Methods

1. Sample size: State that 4 CgH days is considered the MCID between groups and include a citation.

2. Analysis: Baseline comparisons (Comment 11 from the first review):

The authors state that they removed the statistical comparisons of baseline variables between groups. This is not the case. Statements of no significance and/or p-values still appear in the following and these must be removed:

Abstract: Results: First sentence.

Results: Participants: Two sentences on demographics and clinical variables. (The new last sentence is supposed to replace the statistical comparisons with p-values).

Table 1: last column.

Table 3: Baseline column

3. Analysis: Intention-to-Treat:

This has parts:

You added that all patients were included in the analysis even if data were missing.

Also add that participants were analyzed in the group to which they were randomized.

Results

4. Partial eta-squared: (comment 16 from first review):

As per the response to reviewer comments, partial eta-squared has been removed from the text. However, it remains to be removed from Table 2.

5. Table 2: (Comment 17 from first review):

This has not been done as stated by the authors in the response to reviewer comments.

“Show score range for NDI (0-100 with 100 worst) and EQ-5D (0-100 with 100 best) in the second column.”

Discussion

6. 1st Paragraph:

Start the paragraph like this: “This was the first powered randomized trial to compare the effects of cervical and thoracic manipulation for patients with CgH. Cervical manipulation was found to be superior to thoracic manipulation and conventional PT (massage) for improving days with CgH, as well as headache and neck pain and disability, to 6 months.”

Make sure to check the grammar.

Briefly elaborate the contradiction with Borusiak et al. What did these authors find.

7. 2nd Paragraph:

Start the paragraph like this: “The mechanism of action has yet to be determined. Manipulation of the cervical spine may promote afferent nerve fiber activity through stimulation of the cervical joint receptors. It may improve…”

8. 3rd Paragraph:

Start the paragraph like this: “Thoracic manipulation was also found to be more effective than conventional PT in improving both the primary and secondary outcomes.”

Conclusion

9. Try this wording: “The current randomized controlled trial found that cervical spine manipulation was more effective in improving pain parameters (intensity, frequency and threshold), functional disability and quality of life in patients with cervicogenic headache than thoracic spine manipulation and conventional physiotherapy. Future studies are recommended to identify the biomechanical and biochemical mechanisms underlying the clinical and functional changes engendered by manipulation in the treatment of CgH.”

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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

**********

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

Attachments

Attachment

Submitted filename: PONE-D-23-12627_R1_reviewer_Redacted.pdf

PONE-D-23-12627R2Comparative effectiveness of cervical vs thoracic spinal-thrust manipulation for care of cervicogenic headache: a randomized controlled trial.

PLOS ONE

Dear Dr. Nambi,

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.

=================================

Dear authors, thank you for your replies. In the last review, I kindly asked you to indicate the page and lines of each change, but you submitted the article without this information. This complicates and delays the review process. Next time, I will consider this a reason to reject your article. In this review, in addition to highlighting the helped text, you need to report the page (and lines) of each of the changes.

Please follow the last adjustment of the article indicated by the peer-reviewer and me and submit it.

—Regarding minimum clinically important difference (MCID), please report the MCID for each of your outcomes and report it in the results. Outcomes that do not have an MCID established in the literature should be highlighted in the study limitations.

—Delete the "Sr. No." column in Tables 1 and 2.

—Table 1: Remove the p-value column.

—Table 2: This table remains problematic and unintuitive. I'll give an example: the p-value of 0.012** in the first row indicates that the groups have a significant difference, but the table describes three groups, and we know that the TSM and CPT groups have similar scores at baseline (TSM: 17.2 ± 1.9 vs. CPT 17.4 ± 1.7 [p-value?]), while CSM is different from them (16.8 ± 1.8). there are 3 independent comparisons (e.g., 1: TSM vs. CPT [p-value]; 2: TSM vs. CSM [p-value]; 3: CPT vs. CSM [p-value]), so it is necessary to report 3 p-values (one for each comparison). What is important for the RCT is not the overall variance, but the difference between the groups at different times (as in Table 3).

How do you fix this error?

First, delete the p-value column from Table 2 (leaving only the descriptive data); second, add a column to Table 3 and do the same analysis for the baseline time. I have made an example for you (available for download), go to this link and use this model and its headers+legends (Tables 1, 2, and 3):

< https://docs.google.com/document/d/1NdsUtg3x0BSAmpJ3kKI9rDYy_8VL6slb/edit?usp=sharing&ouid=104821689851272179944&rtpof=true&sd=true >

—Finally, if you need to adjust the results session wording because of the table changes, do so.

Kind regards,

André Pontes-Silva

Academic Editor

PLOS ONE

==============================

Please submit your revised manuscript by Mar 28 2024 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• 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'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: https://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

André Pontes-Silva

Academic Editor

PLOS ONE

Journal Requirements:

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. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #2: (No Response)

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). 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 #2: 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 #2: Yes

**********

6. Review Comments to the Author

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Reviewer #2: 1. Not all the p-values for baseline comparisons have been removed. Please remove them:

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Comparative effectiveness of cervical vs thoracic spinal-thrust manipulation for care of cervicogenic headache: a randomized controlled trial.

PONE-D-23-12627R3

Dear Dr. Nambi, 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.

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PLOS ONE