PONE-D-21-05601

Superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis; a randomized, double-blinded, non-inferiority study

PLOS ONE

Dear Dr. Shim,

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PLOS ONE

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Thanks for contributing your original study to PLOS One. It was reviewed by three independent reviewers with complementary expertise in podiatric medicine, biomechanics, and wearables. All reviewers agreed that this study has scientific merits but could be improved further and provided excellent comments. These comments should be addressed before I could recommend acceptance of your manuscript for publication in 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: Yes

Reviewer #2: Yes

Reviewer #3: Yes

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: 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: No

Reviewer #3: 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

Reviewer #3: Yes

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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: A randomized controlled noninferiorty clinical trial was conducted to compare VAS scores of the total contact sole (TCS) with a newly designed three-spike insole (TSI). The study results indicated that the experimental design was noninferior to the standard insole design. Improvements over time were noted in both groups.

Minor revisions:

1- Abstract: Rephrase to improve clarity: “Twenty-eight patients were randomized with equal allocation to either TSI or TCI.”

2- Express numerical p-values more precisely, rather than p < 0.0xx.

3- Line 112: Specify the block size used in the randomization.

4- Line 162: Use standard phrasing: “Twenty-eight patients were randomized, with equal probability, to two groups.”

5- For normally distributed variables, summarize with mean and standard deviation. For nonparametric variables, summarize using median, first, and third quartiles.

6- Indicate if any adverse events occurred during the course of the study.

Reviewer #2: The authors conducted a randomized controlled trial comparing the effect of newly designed insole and total contact insole on plantar fasciitis symptoms. Overall, this study seems well-conducted with reasonable designs and results. I have a few comments.

Introduction

In the first paragraph, please include some data from Korea, if available. For example, the prevalence of plantar fasciitis in Korea, economic cost, etc.

The primary aim is to test new spike insole, and yet it is not very clear to me what are the problems or limitations with conventional insoles. Is the problem just the cost and the duration of fabrication? Also, why did the authors come up with the spike, that is why did the authors believe the spiky design would address the limitations of conventional insoles?

The purpose statement needs to be added.

Methods

In the figure 1, please add a side view photo so that readers can see the height of spikes.

Also, by any chance, did the authors have any data from patients' perceive satisfaction for the new insole? If so, please add the results.

Why did the authors use Mann-Whitney? All the variables were non-parametric? Please confirm.

Results

The figure 2 is difficult to understand. What exactly the asterisk represent? Significant difference in the spike insole group or total contact insole? Do the asterisks represent time x group effect or just time effect?

No new figure should be introduced in discussion so please move figure 4 to results section, and describe the results in this section.

Discussion and conclusion seems to be fine.

Reviewer #3: The authors present a well designed and written study evaluating the efficacy of a novel “3-spike” design shoe insert for the treatment of plantar fasciitis recalcitrant to prior treatment.

To evaluate efficacy the authors enrolled 14 patients to each arm of a non-inferiority comparison between standard orthotic device and novel interventional device. Patients were tracked for 6 months and evaluated using multiple validated subjective scoring systems.

The interventional inserts were created using molds of the patient’s feet, and were 3-D printed to match the patient's weightbearing medial arch.

Utilizing prior experience and observational information regarding the nature of the mold the length and position of the medial arch band of the plantar fascia was interpreted and insoles were either made to be A: load bearing along the full length (Control), or B: fitted with three 2cm diameter elevated “spikes” at center point and distal/proximal along the medial band.

Ultimately the authors found the patient's pain and functional capacity were normalized faster utilizing novel design as compared to standard of care design (control). In this regard the author’s conclude this novel technique to be at minimum non-inferior and likely superior to standard of care.

The authors chose to craft booth insoles using similar methodology to control for variations in design other than the interventional modification. The authors state their believed limitations of this study regarding limited treatment group size and lack of biomechanical or pressure data to support hypothesis of function and loading on novel device. Despite these limitations the authors have designed and executed a well-developed study with novel implications for clinical management of a frequently encountered condition.

I recommend this article for acceptance with minor grammatical revision and look forward to future work from these authors in this field.

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Reviewer #1: No

Reviewer #2: No

Reviewer #3: No

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Attachments

Attachment

Submitted filename: PONE-D-21-05601_reviewer_Edited.pdf

Superior pedal function recovery of newly designed three spike insole over total contact insole in refractory plantar fasciitis; a randomized, double-blinded, non-inferiority study

PONE-D-21-05601R1

Dear Dr. Shim,

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,

Bijan Najafi

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Thanks for your efforts in addressing the initial voiced concerns raised by reviewers. One of the reviewers voiced additional concern. However, since this concern is minor, to avoid further delay in the review process I recommend acceptance of your manuscript with condition that this concern is addressed in revising your proof.

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: (No Response)

Reviewer #2: All comments have been addressed

Reviewer #3: All comments have been addressed

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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: Yes

Reviewer #2: Yes

Reviewer #3: Yes

**********

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

Reviewer #1: Yes

Reviewer #2: Yes

Reviewer #3: 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: No

Reviewer #2: No

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. 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: Line 151: Clarify how the non-inferiority test was used. Specifically state the hypothesis it tested.

Thoroughly proofread the manuscript to ensure proper grammar.

Reviewer #2: I thank the authors for addressing my comments. The manuscript looks good. I have no additional comments.

Reviewer #3: Thank you for contributing your original study to PLOS One & making revisions as described by reviewers and editors. After further review of revised materials I recommend acceptance of your manuscript for publication in PLOS One, and look forward to further work from this group.

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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