Efficacy of an Acupressure Mat in Association with Therapeutic Exercise in the Management of Chronic Low Back Pain: A Prospective Randomized Controlled Study

Round 1

Reviewer 1 Report

Thank you for the opportunity to review this interesting study. Here is my feedback:

Major comments:

1. The introduction is well written, with one exception. You jump very abruptly form describing state-of-the-art to the last part about the study purpose. Before stating the purpose, you should summarize what has been done and what hasn’t been done in previous literature. This way, it will be clearer what you study adds to the existing body of work. Note that you state ‘’ Systematic reviews on acupressure support significant effects on chronic symptoms, such as pain and sleep disturbance [15].’’ – One might ask, what is the point of the present study? What does it add to the existing studies?
2. Participants section is too vague. Were the patients recruited through advertisements, or were they referred to you via doctors? How and when as eligibility criteria (i.e. the presence of specific identified cause) verified?
3. ‘’Furthermore, we did not use specific instruments in order to monitor the home use of the mat and the adherence to home exercises, but only relied on what the patients reported’’ Okay, fair enough, but can you report what the patients reported to you?
4. The figures in results section can be substantially improved in terms of ‘’scientific’’ appearance (now it is evident that the figures are done in excel; even using Excel, they can be done better (e.g. thinner lines, different font, black color instead of gray…).
5. In the results, it would be good to include either effect sizes or percentage of change alongside p-values.
6. I think your conclusion needs to be toned down, as only 1 measure (pain) was substantially more reduced in experimental group.

Specific comments:

1. ‘’In literature, the lifetime prevalence for LBP varies 31 between 51 and 84%.’’ Such sentence needs referencing. If this was derived from [2] which is listed later, place [2] also behind this sentence.
2. Please structure the discussion into separate paragraphs.
3. You do not need to repeat p-values in the discussion.

Author Response

Reviwer 1

Major comments:

1. The introduction is well written, with one exception. You jump very abruptly form describing state-of-the-art to the last part about the study purpose. Before stating the purpose, you should summarize what has been done and what hasn’t been done in previous literature. This way, it will be clearer what you study adds to the existing body of work. Note that you state ‘’ Systematic reviews on acupressure support significant effects on chronic symptoms, such as pain and sleep disturbance [15].’’ – One might ask, what is the point of the present study? What does it add to the existing studies?

Answer: The purpose of the study is indicated at the end of the introduction with reference to the fact that a new device with acupressure has been tested

1. Participants section is too vague. Were the patients recruited through advertisements, or were they referred to you via doctors? How and when as eligibility criteria (i.e. the presence of specific identified cause) verified?

Answer: We've better specified enlistment policies as required

1. ‘’Furthermore, we did not use specific instruments in order to monitor the home use of the mat and the adherence to home exercises, but only relied on what the patients reported’’ Okay, fair enough, but can you report what the patients reported to you?

Answer: However, patients reported high adherence to treatment

1. The figures in results section can be substantially improved in terms of ‘’scientific’’ appearance (now it is evident that the figures are done in excel; even using Excel, they can be done better (e.g. thinner lines, different font, black color instead of gray…).

Answer: we have modified tables and figures to the best of our ability

1. In the results, it would be good to include either effect sizes or percentage of change alongside p-values.

Answer: We have specified for each item the significance of the data also and above all in terms of the relevance of the data

1. I think your conclusion needs to be toned down, as only 1 measure (pain) was substantially more reduced in experimental group.

Answer: We have modified as suggested

Author Response File: Author Response.docx

Reviewer 2 Report

This is very interesting work gives new opportunities to fight chronic back pain. However, I have noticed some irregularities in the selection of the group. In the case of back pain, one of the factors influencing its appearance is the age of the respondents. Is the age range of 22-80 years too big in such a small group of study???? 25% of source entries are more than 10 years old - literature needs to be updated.

Author Response

Reviewer 2

This is very interesting work gives new opportunities to fight chronic back pain. However, I have noticed some irregularities in the selection of the group. In the case of back pain, one of the factors influencing its appearance is the age of the respondents. Is the age range of 22-80 years too big in such a small group of study???? 25% of source entries are more than 10 years old - literature needs to be updated.

Answer: As far as literature is concerned, we agree with the reviewer that the studies we have found on acupressure treatments are predominantly more than ten years ago. In fact, this work renews the use of acupressure tools for non-specific chronic low back pain.

Author Response File: Author Response.docx

Reviewer 3 Report

The study design has not been adequately described. I have no idea what the control group did? The exercise intervention involved other tasks besides using the acupressure mat so really you have no way of finding out the effects from just the ‘mat’. Your writing is very poor throughout the whole manuscript. You have one paragraph for the Introduction and one paragraph for the Discussion. There are methodological issues surrounding the adherence to the home-based exercise. Below are further comments.

Remove all vertical lines from tables and horizontal lines from figures.

Line 21: What was the other group participants were divided into?

Line 32: LBP is not a disease.

Line 55: “..which has been..”

Line 60: “A systematic review has also…”

Line 129-134: Please provide information about compliance with the program and adherence to sessions.

Line 170: Allocated to an intervention does not include the control group. Unless a shame was used? Please also provide more information about the control group in the Methods along with assessing their compliance with the study instructions.

Line 232: “…measured through..”

Lines 230-271: These are results that are being reported. Where is the discussion?

Line 243: “As for pain quality..”

Line 264: “..both groups..”

Line 338: “In two prospective randomized trials..”

Line 346: If not statistically significant then there is no difference.

Line 357: “..mat has substantial..”

Line 362-366: This sentence does not make sense. Please rewrite.

Lines 391: “…makes this device a valid tool for the long-term management for low back pain.”

Author Response

Reviewer 3

The study design has not been adequately described. I have no idea what the control group did? The exercise intervention involved other tasks besides using the acupressure mat so really you have no way of finding out the effects from just the ‘mat’. Your writing is very poor throughout the whole manuscript. You have one paragraph for the Introduction and one paragraph for the Discussion. There are methodological issues surrounding the adherence to the home-based exercise. Below are further comments.

Remove all vertical lines from tables and horizontal lines from figures.

Line 21: What was the other group participants were divided into?

Line 32: LBP is not a disease.

Line 55: “..which has been..”

Line 60: “A systematic review has also…”

Line 129-134: Please provide information about compliance with the program and adherence to sessions.

Line 170: Allocated to an intervention does not include the control group. Unless a shame was used? Please also provide more information about the control group in the Methods along with assessing their compliance with the study instructions.

Line 232: “…measured through..”

Lines 230-271: These are results that are being reported. Where is the discussion?

Line 243: “As for pain quality..”

Line 264: “..both groups..”

Line 338: “In two prospective randomized trials..”

Line 346: If not statistically significant then there is no difference.

Line 357: “..mat has substantial..”

Line 362-366: This sentence does not make sense. Please rewrite.

Lines 391: “…makes this device a valid tool for the long-term management for low back pain.”

Answer: As indicated by the reviewer we tried to better describe the plant of our work by specifying better what the control group did. We did not design a treatment arm only with the mat but we randomized patients in two groups of which one (EG) does exercises plus mat and the other (CG) only exercises.

We have tried to make appropriately all the changes required by reviewer

Author Response File: Author Response.docx

Round 2

Reviewer 1 Report

I have no further concerns, all of my suggestions have been addressed. Best regards. 

Author Response

Please see the attachment

Author Response File: Author Response.docx

Reviewer 2 Report

The authors only responded to the objection to the use of a bibliography older than 10 years - I understand that we want to revisit this topic.
However, I did not receive an explanation as to why the study was conducted on people of such different ages. The etiology of back pain varies between the ages of 22 and 80. There is also no information about previous attempts to treat pain by people subjected to the research experiment.

The work needs to be supplemented with information on the selection of the group. The authors' explanation that the group was recruited from people coming to the clinic is insufficient (line 90-95) 

Author Response

Please see the attachment

Author Response File: Author Response.docx

Reviewer 3 Report

Unfortunately I am not convinced this study was conducted in a manner that reduces the risks of potential confounders from impacting the results and conclusions drawn.

Author Response

Please see the attachment

Author Response File: Author Response.docx

Round 3

Reviewer 2 Report

I have no comments on the current version, although I have not obtained a justification why the authors used such a wide age range.

Reviewer 3 Report

.