Author s response to reviews Title: Effects of whole body vibration exercise on neuromuscular function for individuals with knee osteoarthritis: study protocol for a randomized controlled trial Authors: Lin Wang (wanglin.sus@gmail.com) Zhangqi Lai (laizhangqi@126.com) Xueqiang Wang (qiang897@163.com) Seullee Lee (2812479481@qq.com) Xihe Hou (houxihe@126.com) Version: 1 Date: 11 Aug 2017 Author s response to reviews: Dear reviewers and editors, On behalf of our research team, I would like to take this opportunity to kindly thank you for offering your time to review our manuscript. Accordingly, we have revised the manuscript (TRLS-D-16-00794) based on these comments and have attached it for your consideration. Revisions were highlighted using red font in text. We have also included our responses to the various points raised by the reviewer below. We look forward to hearing from you in due course. Thank you. Yours sincerely, Lin Wang, MB, PhD Associate Professor, Chairman, Department of Sports Rehabilitation, Shanghai University of Sport
Vice-Director, Hospital of Orthopaedics, Shanghai University of Sport Shanghai, China. Tel : (86) 21 5125 3426 Fax : (86) 21 5125 3470 Email: wanglin@sus.edu.cn Reviewer reports: Reviewer #1: The manuscript "Effects of whole body vibration exercise on neuromuscular function for individuals with knee osteoarthritis: study protocol for a randomized controlled trial" aims to investigate the effect of a 12-week whole body vibration exercise on the neuromuscular function of individuals with knee osteoarthritis. However, the paper lacks of methodological rigour. The main reasons are present below: A: Thank you for your positive comments. Your comments were highly insightful and enabled us to greatly improve the quality of our manuscript. - Even though the study aims to assess neuromuscular function, the authors never defined what do they mean by neuromuscular function. A: Thank you for your suggestion. Neuromuscular function is the ability of the nervous system produces muscle activities and maintains body movements through integration of the afferent signals from peripheral neurons and control of the efferent signals. We have added the description in text. - The authors seem confused about primary and secondary outcomes. Their primary outcome should be the assessment of the neuromuscular function. A: Thank you for your suggestion. We revised representation of primary and secondary outcomes the in accordance with your recommendations. - It is not clear why the study has three groups. The control group is the health education group. Not clear why the authors decide to have a resistance training group. A: Thank you for your suggestion. The American College of Rheumatology recommended resistance exercise as an effective non-pharmacological treatment for patients with KOA in
2012. However, limited study was conducted to investigate difference on neuromuscular function among individuals with KOA between WBV training and resistance training. Therefore, we decided to add a resistance training group in the study. - The authors did not perform a sample size calculation. A: Thank you for your suggestion. The power analysis with settings at α = 0.05, power (1 β) = 0.80 and effect size = 0.25 showed that three group of 120 participants was the required sample size. Given the dropouts, we decided to recruit 180 participants for the research. Reviewer #2: This manuscript titled "Effects of whole body vibration exercise on neuromuscular function for individuals with knee osteoarthritis: study protocol for a randomized controlled trial" describes a protocol study aimed to investigate the effect of a 12-week whole body vibration (WBV) exercise on the neuromuscular function of individuals with knee osteoarthritis (KOA). Current systematic reviews and meta-analysis shows few studies with good methodology and with lack of consistency regarding its effects on KOA symptoms, so RCT's of this nature are of great value. A: Thank you for your positive comments. Comments (General): The article is easy to understand, with an appropriate sample size and reliable assessment tools. WBV exercise and RT exercise seems feasible to execute and replicate in daily clinical practice. A: Thank you for your positive comments. Your comments were highly insightful and enabled us to greatly improve the quality of our manuscript. Specific Comments: Abstract: Lines 29 to 36: Control group will receive 12 weeks of health education as WBV and RT groups? It is not clear in the Methods/Design section. A: Thank you for your suggestion. The control group will receive health education for 12 weeks.
Background: N/A Methods: Study design Lines 12 to 17. As mentioned on background section, "neuromuscular function contributes to the development and/or progression of KOA". Why control group will receive only health education program? It is not clear for this reviewer the scientific rationale for this intervention. A: Thank you for your suggestion. During the invention phase, the participants in control group will receive only education program. After the analysis, if the WBV training improves the neuromuscular function or the physical performance, we will provide participants in control group with the WBV training. Line 22. How sample size was estimated? Please review that. A;Thank you for your suggestion. The power analysis with settings at α = 0.05, power (1 β) = 0.80 and effect size = 0.25 showed that three group of 120 participants was the required sample size. Given the dropouts, we decided to recruit 180 participants for the research. How allocation concealment will be performed? Please review that. A:Thank you for your suggestion. At first, the participants will allocated randomly used a computer-generated randomization. Only the research designer and trainer will know the randomized assignments. The assessors will unaware of the randomization and were not involved in the exercise interventions. Inclusion criteria Line 07. Minimum pain intensity complaint will be required to be included in the study?
A: Thank you for your suggestion. Previous researches inclusion criteria didn t include the minimum pain intensity complaint. According to their baseline of self-reported pain, we might set the minimum pain intensity complaint for 7. Interventions Lines 22 to 39. How long will take each session of WBV exercise? A: Thank you for your suggestion. Each session of WBV exercise will last 30 minutes (60 seconds for vibration, and 60 seconds for rest). Primary outcome measures Lines 15 to 17. Self-reported pain will be used to assess pain related to joint movement? Which joint? A: The VAS and WOMAC-pain will be used to assess self-reported pain related to knee joint movement. Statistical analysis Authors claim that intention-to-treat analysis and linear mixed model will be performed, but missing data will be handling by replacing the last observation. As linear mixed-effects handle missing data pretty well, the need for replacing it is not clear for this reviewer. A: Thank you for your suggestion. We will use repeated-measurement analysis of variance will be evaluated for between- and with- group difference (baseline, post-intervention and follow-up). Bonferroni post hoc test will used for comparing the results. Spirit Checklist Methods: Participants, interventions, and outcomes Sample size (item 14) is not clear on page 07 as declared by the authors. Please review that. A: Thank you for your suggestion. The power analysis with settings at α = 0.05, power (1 β) = 0.80 and effect size = 0.25 showed that three group of 120 participants was the required sample size. Given the dropouts, we decided to recruit 180 participants for the research. The sample size (item 14) was declared on page 07.
Methods: Assignment of interventions Allocation concealment mechanism (item 16b) is not clear on page 07 as declared by the authors. Please review that. Implementation (item 16c) is not clear on page 07 as declared by the authors. Please review that. A: Thank you for your suggestion. At first, the participants will allocated randomly used a computer-generated randomization. Only the research designer and trainers will know the randomized assignments. The assessors will unaware of the randomization and were not involved in the exercise interventions. The allocation concealment mechanism was declared on page 08. A total of 180 patients from community centers in Yangpu District, Shanghai, China will be included through advertisements placed in centers by recruiter. Participants who meet all study inclusion criteria and consent to participate will be randomly allocated to the WBV exercise, lower extremity RT, and health education groups via using a computer-generated randomization by research designer. And the nurse will assign participants to interventions. The implementation (item 16c) was declared on page 07-08.