Comparing two protocols of shock wave therapy for patients with plantar fasciitis: A pilot study

Fatima A. L. Kalbani; Reime Shalash; Raneen Qadah; Tamer Shousha

doi:10.1371/journal.pone.0302553

Peer Review History

Original SubmissionDecember 31, 2023
4 Feb 2024 Decision Letter - Filippo Migliorini, Editor PONE-D-23-43583Comparing Two Protocols of Shock Wave Therapy for Patients with Plantar Fasciitis: A Pilot StudyPLOS ONE Dear Dr. Shousha, 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 Mar 20 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, Filippo Migliorini Academic Editor PLOS ONE Journal requirements: When submitting your revision, we need you to address these additional requirements. 1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf Additional Editor Comments: Reviewer 1: The authors present a meta-analysis comparing and comparing the effectiveness of two extracorporeal shock wave therapy (ESWT) protocols combined with a specified physical therapy program in relieving pain and improving foot function in individuals with plantar fasciitis. This topic is of great clinical interest and has been extensively discussed in the literature. The analysis itself is very thoroughly performed and clearly explained. The discussion is precious, and I also appreciate the explanation of your way of understanding and performing the study. However, some minor and major corrections should be addressed. L61-62: Does it cause only heel pain? Materials and methods: It has not been specified if you followed a guideline and, in this case, which one. Discussion: L306: A short description of the anatomical structures and the pathological alterations are needed before talking about the impact of the shock waves on cells. Conclusion: no comments [Note: HTML markup is below. Please do not edit.] 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 ******** 2. Has the statistical analysis been performed appropriately and rigorously? Reviewer #1: I Don't Know ****** 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: Yes ****** 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 ****** 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: The authors present a meta-analysis comparing and comparing the effectiveness of two extracorporeal shock wave therapy (ESWT) protocols combined with a specified physical therapy program in relieving pain and improving foot function in individuals with plantar fasciitis. This topic is of great clinical interest and has been extensively discussed in the literature. The analysis itself is very thoroughly performed and clearly explained. The discussion is precious, and I also appreciate the explanation of your way of understanding and performing the study. However, some minor and major corrections should be addressed. L61-62: Does it cause only heel pain? Materials and methods: It has not been specified if you followed a guideline and, in this case, which one. Discussion: L306: A short description of the anatomical structures and the pathological alterations are needed before talking about the impact of the shock waves on cells. Conclusion: no comments ****** 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. 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 ******** [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. https://doi.org/10.1371/journal.pone.0302553.r001
Revision 1
7 Feb 2024 Author Response Dear Reviewer, Thank you for your thorough revision and helpful comments… Kindly find below, the authors’ reply on a point-to-point basis. Kindly Comment Authors’ reply L61-62: Does it cause only heel pain? Added lines 62-64: ‘, with symptoms of stabbing, non-radiating pain in the early morning of the proximal medio-plantar surface of the foot; the pain becomes worse at the end of the day [2].” Materials and methods: It has not been specified if you followed a guideline and, in this case, which one As this is a pilot study, we followed the “CONSORT 2010 checklist of information to include when reporting a pilot or feasibility trial” which is already one of the journal’s requirements for submission and was uploaded with the supporting files. In addition, the sample calculation was done in accordance to the study “Hertzog MA. Considerations in determining sample size for pilot studies. Res Nurs Health. 2008;31: 180–191” reference 9 stated in line 115. All assessment and treatment parameters have references included in text L306: A short description of the anatomical structures and the pathological alterations are needed before talking about the impact of the shock waves on cells. Added lines 308-312(version without track changes) / 313-317( version with track changes): “This is due to the fact that plantar fasciitis is a biomechanical overuse syndrome resulting in degenerative changes at its attachment to the calcaneus. Histologic examination of samples taken from plantar fascia release surgeries revealed myxoid degeneration with fragmentation and degeneration of the plantar fascia and bone marrow vascular ectasia [2].” Attachments Attachment Submitted filename: response to reviewers.docx https://doi.org/10.1371/journal.pone.0302553.r002
17 Mar 2024 Decision Letter - Filippo Migliorini, Editor PONE-D-23-43583R1Comparing Two Protocols of Shock Wave Therapy for Patients with Plantar Fasciitis: A Pilot StudyPLOS ONE Dear Dr. Shousha, 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 May 01 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, Filippo Migliorini 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. Additional Editor Comments: The article has been evaluated by a statistician. Please revise the manuscript accordingly, thank you Comments: This manuscript reported results from a pilot randomized control trial with three arms: two different shock wave therapy and one control. There are 30 patients randomized in this trial. In order to meet the standard for publication, the statistical analysis part needs revisions and clarification as shown below: 1. What is the block size used in the permuted block randomization? This information should be added. 2. The follow chart shows the final number of patients analyzed was 9, 9 and 8 for three groups. But were all 10 patients' baseline measurements analyzed and shown in Table 1? It is not clear how compliance was defined. 3. Because of the small sample size in each group, median+/-IQR should also be reported. Because of the same reason, Shapiro-Wilks test is not appropriate for testing the normality assumption. 4. Table 3 reports the comparison between group A and group B as well as the first row in Table 4. First, such information is duplicated so Table 3 could be removed. Second, It is confusing that p-values from the same comparisons in these two tables were not the same. 5. Line 251 and Line 269 have duplicated information presented. 6. There are longitudinal measurements observed from each study participants. It is better to draw individual profile of each outcome over time to show the difference visually. More importantly, the statistical analysis such as linear mixed effect model is better to take advantage of such longitudinal design for estimating the difference between groups, which would be more powerful. Such model can also use all available observed data even if some study participants only had baseline measurements recorded. 7. There should be more details about future sample size calculation. For example, which group difference was the effect size of 0.25 from, group A vs group C, group B vs group C, or from all three groups? How was the effect size calculated? Which outcome was used in that effect size calculation, FFI or VAS? Which statistical test was used in this sample size calculation? What is the alpha and beta level used in such calculation? [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 #2: All comments have been addressed ******** 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: Partly ****** 3. Has the statistical analysis been performed appropriately and rigorously? Reviewer #2: No ****** 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 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 #2: This manuscript reported results from a pilot randomized control trial with three arms: two different shock wave therapy and one control. There are 30 patients randomized in this trial. In order to meet the standard for publication, the statistical analysis part needs revisions and clarification as shown below: 1. What is the block size used in the permuted block randomization? This information should be added. 2. The follow chart shows the final number of patients analyzed was 9, 9 and 8 for three groups. But were all 10 patients' baseline measurements analyzed and shown in Table 1? It is not clear how compliance was defined. 3. Because of the small sample size in each group, median+/-IQR should also be reported. Because of the same reason, Shapiro-Wilks test is not appropriate for testing the normality assumption. 4. Table 3 reports the comparison between group A and group B as well as the first row in Table 4. First, such information is duplicated so Table 3 could be removed. Second, It is confusing that p-values from the same comparisons in these two tables were not the same. 5. Line 251 and Line 269 have duplicated information presented. 6. There are longitudinal measurements observed from each study participants. It is better to draw individual profile of each outcome over time to show the difference visually. More importantly, the statistical analysis such as linear mixed effect model is better to take advantage of such longitudinal design for estimating the difference between groups, which would be more powerful. Such model can also use all available observed data even if some study participants only had baseline measurements recorded. 7. There should be more details about future sample size calculation. For example, which group difference was the effect size of 0.25 from, group A vs group C, group B vs group C, or from all three groups? How was the effect size calculated? Which outcome was used in that effect size calculation, FFI or VAS? Which statistical test was used in this sample size calculation? What is the alpha and beta level used in such calculation? ****** 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 #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. https://doi.org/10.1371/journal.pone.0302553.r003
Revision 2
27 Mar 2024 Author Response Dear Reviewer, Thank you for your thorough revision and helpful comments… Kindly find below, the authors’ reply on a point-to-point basis. Kindly note that the line numbers mentioned below are in the copy with track changes Warm regards, Comment Authors’ reply What is the block size used in the permuted block randomization? Thank you for your comment. Lines 125 -126: added “permuted block randomization of different sizes (3,6)” The flow chart shows the final number of patients analyzed was 9, 9 and 8 for three groups. But were all 10 patients' baseline measurements analyzed and shown in Table 1? It is not clear how compliance was defined. Thank you for your comment. The percentages were checked, and correct percentages were edited in text lines: 230-232 as well as in Table 1 Compliance/ adherence was calculated by dividing the number of participants completing the study by the total number of each group . lines 226-227 Because of the small sample size in each group, median+/-IQR should also be reported. Because of the same reason, Shapiro-Wilks test is not appropriate for testing the normality assumption. Thank you for your comment. Median and IQR values added to Table 1 With regards to the Shapiro-wilk test, the choice was based on previous literature revealing the Shapiro-wilk appropriate for sample sizes less than 50. Elliott AC, Woodward WA. Statistical analysis quick reference guidebook with SPSS examples. 1st ed. London: Sage Publications; 2007 Mishra P, Pandey CM, Singh U, Gupta A, Sahu C, Keshri A. Descriptive statistics and normality tests for statistical data. Ann Card Anaesth. 2019 Jan-Mar;22(1):67-72. doi: 10.4103/aca.ACA_157_18. PMID: 30648682; PMCID: PMC6350423. Ghasemi A, Zahediasl S. Normality tests for statistical analysis: a guide for non-statisticians. Int J Endocrinol Metab. 2012 Spring;10(2):486-9. doi: 10.5812/ijem.3505. Epub 2012 Apr 20. PMID: 23843808; PMCID: PMC3693611. Table 3 reports the comparison between group A and group B as well as the first row in Table 4. First, such information is duplicated so Table 3 could be removed. Second, It is confusing that p-values from the same comparisons in these two tables were not the same. The table has been removed and replaced with the pairwise comparisons of the KW test Line 251 and Line 269 have duplicated information presented Duplication removed There are longitudinal measurements observed from each study participants. It is better to draw individual profile of each outcome over time to show the difference visually. More importantly, the statistical analysis such as linear mixed effect model is better to take advantage of such longitudinal design for estimating the difference between groups, which would be more powerful. Such model can also use all available observed data even if some study participants only had baseline measurements recorded Thank you for this comment… The linear mixed effect model depends on the assumption for normality which is not available in our case since the data was not normally distributed. There should be more details about future sample size calculation. For example, which group difference was the effect size of 0.25 from, group A vs group C, group B vs group C, or from all three groups? How was the effect size calculated? Which outcome was used in that effect size calculation, FFI or VAS? Which statistical test was used in this sample size calculation? What is the alpha and beta level used in such calculation? Thank you for your valuable comment… Added lines 288-292: For future sample size calculations, considering the VAS as the primary outcome, the effect size for post-hoc Kruskal-Wallis test was calculated using the formula r = z/√N (r: effect size; z: z value; N: Observation number). The effect sizes between the groups were reported as 0.282, 1.09 and 0.796 respectively. A total sample size of 123 participants was calculated using the G-power software for the ANOVA repeated measures within-between interaction test, assuming an effect size of 0.282, α level of 0.05, and power of 0.95. Attachments Attachment Submitted filename: Responses.docx https://doi.org/10.1371/journal.pone.0302553.r004
8 Apr 2024 Decision Letter - Filippo Migliorini, Editor Comparing Two Protocols of Shock Wave Therapy for Patients with Plantar Fasciitis: A Pilot Study PONE-D-23-43583R2 Dear Dr. Shousha, 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. An invoice will be generated when your article is formally accepted. Please note, if your institution has a publishing partnership with PLOS and your article meets the relevant criteria, all or part of your publication costs will be covered. Please make sure your user information is up-to-date by logging into Editorial Manager at Editorial Manager® and clicking the ‘Update My Information' link at the top of the page. If you have any questions relating to publication charges, please contact our Author Billing department directly at authorbilling@plos.org. If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. Kind regards, Filippo Migliorini Academic Editor PLOS ONE Additional Editor Comments (optional): Reviewers' comments: https://doi.org/10.1371/journal.pone.0302553.r005
Formally Accepted
26 Apr 2024 Acceptance Letter - Filippo Migliorini, Editor PONE-D-23-43583R2 PLOS ONE Dear Dr. Shousha, I'm pleased to inform you that your manuscript has been deemed suitable for publication in PLOS ONE. Congratulations! Your manuscript is now being handed over to our production team. At this stage, our production department will prepare your paper for publication. This includes ensuring the following: * All references, tables, and figures are properly cited * All relevant supporting information is included in the manuscript submission, * There are no issues that prevent the paper from being properly typeset If revisions are needed, the production department will contact you directly to resolve them. If no revisions are needed, you will receive an email when the publication date has been set. At this time, we do not offer pre-publication proofs to authors during production of the accepted work. Please keep in mind that we are working through a large volume of accepted articles, so please give us a few weeks to review your paper and let you know the next and final steps. Lastly, if your institution or institutions have a press office, please let them know about your upcoming paper now to help maximize its impact. If they'll be preparing press materials, please inform our press team within the next 48 hours. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org. If we can help with anything else, please email us at customercare@plos.org. Thank you for submitting your work to PLOS ONE and supporting open access. Kind regards, PLOS ONE Editorial Office Staff on behalf of Dr Filippo Migliorini Academic Editor PLOS ONE https://doi.org/10.1371/journal.pone.0302553.r006

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