A Study Protocol on the Effectiveness of Radial Shockwave Therapy on Myofascial Pain Syndrome: A Mixed Methods Study That Combines a Randomised Control Trial and Semi-Structured Interviews

Abstract

Background: Myofascial pain syndrome (MPS) is a common, costly and often persistent musculoskeletal problem. Radial shockwave (RSW) is one of the most common treatments for MFS. However, there is very low-level evidence to support its short-term benefit, due to poor methodological qualities. Furthermore, previous studies have not considered the experiences of patients regarding this intervention. This study will investigate the effectiveness of RSW compared to a sham (placebo) for patients with MPS and establish the experiences of patients receiving the treatment. Methods: A mixed methods study of a pragmatic randomised controlled trial and semi-structured-interviews that will involve 120 potential participants with MPS is used. The intervention group will receive six sessions of RSW: 1.5 bars, 2000 pulses, frequency 15 Hz. The control group will receive an identical treatment except that they will receive a no-energy shock of 0.3 bar. Results: The outcome measures are a numeric pain scale, neck disability index (NDI), pressure pain threshold (PPT) and SF-12 questionnaires at 4 and 8 weeks’ follow-up between the two groups. Conclusion: The expectation is that this study will add to the body of knowledge required to make effective treatment choices on RSW in the management MFS.