PONE-D-24-54076Efficacy of Superimposing Neuromuscular Electrical Stimulation onto Core Stability Exercise in Patients with Nonspecific Low Back Pain: A Study Protocol for a Randomized Controlled TrialPLOS ONE

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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: Partly

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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: Partly

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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

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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 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

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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

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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:  This is a well designed protocol for a randomised controlled trial to study the efficacy of superimposing NMES onto core stability exercise in patients with nonspecific low back pain. I have few comments.

1. The test statistic used to calculate sample size needs to be mentioned.

2. If the participants cannot be blinded then what is the point of using sham-NMES?

3. Why 6-weeks intervention period instead of 8-weeks?

4. Discussion section seems like repetition of the introduction. I think, the discussion section should summarise the protocol and justify the methods adopted.

Reviewer #2:  The aim of this study is to assess the efficacy of superimposing neuromuscular electrical stimulation (NMES) onto Core Stability Exercise (CSE) for improving muscle activation, function, and proprioception as well as reducing pain in non-specific low back pain (NSLBP) patients.

This study is very clear and detailed regarding scientific content, experimental protocol, and physiological and clinical measurements. I believe the authors have devised a protocol that will provide significant details regarding NSLBP treatment through the CSE and NMES use. The results of this study can improve existing rehabilitation protocols to manage chronic pain in these patients.

I have only some questions and suggestions to make to the authors, to improve their study protocol.

Pag. 4, line 153 ‘Eligibility criteria’. Were these inclusion/exclusion criteria chosen based on previous studies? If so, which ones?

Pag. 5, line 208 ‘Table 1. core stability exercise’: The exercises and their progress over the weeks are clearly shown in this table. It would be helpful if the authors specified that the progression of exercises is tailored to the individual patient's abilities. As an example, it is not stated that a patient at week 3 is already capable of doing these exercises because he may be suffering from lumbar pain. In other words, the general progression is fine, but the timing of it should depend on the individual characteristics. I suggest the authors to specify this point.

Pag. 7, line 217 ‘The stimulation pulse width will be set to 200 μs,..’: Why did the authors choose this pulse width? Could they mention the source from which they took this parameter?

Pag. 7, lines 225 – 227 ‘Each session will consist of 8 different exercises, performing 1 set of 10 repetitions per exercise, lasting 20 minutes per session, once per day, 3 days per week.’: Also here, why have they chosen this protocol? Is there a progression in the number of series/repetitions, or an increase in the intensity of NMES in the experimental group, during the 6 weeks of intervention? After a few weeks you may need to increase the load of the training session (always respecting the patient’s pain).

Reviewer #3:  The proposed research outlines a clinical randomized controlled trial investigating the effects of a six-week training program involving neuromuscular electrical stimulation (NMES) superimposed on core stability exercises (CSE) in individuals with non-specific low back pain (NSLBP). The protocol aims to assess physiological, functional, and proprioceptive outcomes following the exercise protocol compared to a control group performing only sham stimulation. Overall the study is well written, and the methodology is faitly robus. However, there are several issues in the elaboration of the study's rationale and other minor shortcomings that need to be addressed.

Major issues

- Although the introduction section includes a well-written section discussing the effects of superimposed NMES on spinal and supraspinal mechanisms, it lacks sufficient detail regarding the physiological, functional, and proprioceptive aspects that are later outlined as assessment measures in the methods section. The study's rationale would significantly benefit if these aspects were clearly outlined in the introduction.

- The methods also lacks comprehensive information on the electrical stimulation characteristics such as NMES frequency, waveform, sensitivity of the NMES modulation.

- The duration of the exercise program and the overall protocol lack sufficient references to justify the choices made by the authors. Please include appropriate citations to support the overall CSE protocol.

Minor issues

Introduction

-L 95/L 98. "combined with", "overlaying". For better clarity please use "superimposed on" throughout the entire document.

Methods

- L 130. Is there any reference that confirms that 6 weeks of CSE are enough to carry significant physiological/functional adaptation?

- L156. The phrase "no treatment intervention utilized" is unclear. Please rephrase for better clarity. What exactly does this refer to?.

-L 192. Specify what is meant by "necessary adjustments to the treatment protocol." What adjustments are planned, and under what circumstances will they be made?

-L 213. Please clarify which electrode will function as the cathode and which as the anode in this NMES configuration.

-L 217. In line with the comment above. Which NMES pulse frequency will be used? Based on what rationale?

-L 225-227. Include appropriate references to justify the selection of the exercise protocol.

-L244-245. Based on what evidence did the authors choose a interelectrode distance of 2.5 cm?

-L 265-269. Regarding EMG processing, the procedures for manually selecting activation timings need further clarification. For instance: Is there a specific signal threshold used? How are "baseline levels" defined? Provide clear, step-by-step details.

-L 314. Add a space after "..located at S1."

-L 347. If a statistical design comparing groups (between-group) and repeated measures over time (within-group) is used, define it as a mixed ANOVA.

Discussion

While the discussion of the RCT is well-written overall, it lacks clarity regarding the EMG-related improvements anticipated from the proposed exercise protocol. Please elaborate on how the protocol is expected to influence EMG outcomes and the significance of these improvements.

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Reviewer #1: Yes:  Dr Shah-Jalal Sarker

Reviewer #2: No

Reviewer #3: No

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Attachments

Attachment

Submitted filename: Reviewers comment.docx

Efficacy of Superimposing Neuromuscular Electrical Stimulation onto Core Stability Exercise in Patients with Nonspecific Low Back Pain: A Study Protocol for a Randomized Controlled Trial

PONE-D-24-54076R1

Dear Dr. Yongzhong Li,

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,

Luciana Labanca

Academic 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: This is very good protocol. I had some comments and the authors have addressed all of my comments appropriately and hence this can be published.

Reviewer #2: The authors have done an excellent job and have responded to all my comments, making the required changes to the manuscript. As a consequence, the manuscript is greatly improved and, in my opinion, ready for publication.

Reviewer #3: I would like to thank the authors for the thourogh response to each comment. I believe that the manuscript has improved as a result and I have no further comment or concern about the manuscript.

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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: Yes:  Dr Shah-Jalal Sarker

Reviewer #2: Yes:  Martina Scalia

Reviewer #3: No

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