CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 70 enrolled
Drug / intervention
Radial shockwave therapydevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05381987
NCT05381987N/ACompleted

The Effectiveness of Radial Shockwave Therapy on Myofascial Pain Syndrome: A Mixed Method Study That Combines a Randomised Control Trial and Semi-Structured Interview.

King Faisal Specialist Hospital & Research Center·interventional·Posted May 19, 2022·Updated Mar 17, 2025

In Brief

A clinical study evaluating Radial shockwave therapy for Myofascial Pain Syndrome of Neck. Completed, enrolled 70 participants across 1 site.

Detailed Summary

Introduction: Myofascial pain syndrome (MPS) is a common, costly and often persistent musculoskeletal problem. Radial shockwave (RSW) is one of the most common treatment for MFS. However, a recent systematic review found very low-level evidence to support its short-term benefit, due to poor methodological qualities. The authors therefore recommended further large scale, good quality placebo-controlled trials (RCT) in this area. Further still, previous studies have not considered the experiences of patient regarding this intervention. Study Objectives: To determine the effectiveness of RSW compared to placebo for the treatment of patients with MPS in neck and upper back, and to establish the experiences of patients receiving the treatment. Research Questions: Is RSW therapy more effective at improving MPS compared to a placebo? What are the experiences of patients with MPS receiving this treatment? Methods: A pragmatic double blind RCT to investigate the effectiveness of RSW on patients with MPS and a semi-structured-interview to investigate the patients' experience of receiving the treatment. Sample: 120 potential participants with MPS for the RCT and 20 participants for the semi-structured qualitative interview. Interventions: The Intervention group will receive a total of 6 sessions of RSW following manufacturer's parameters: 1.5 bar, pulses 2000, frequency 15 Hz (Time 3 minutes). The Control group will receive an identical treatment except that the they will receive a no energy shock of 0.3 bar, frequency 15 and no pulses. Outcome measures: Improvements in the patient's numeric pain scale (NPS), neck disability index (NDI), pressure pain threshold (PPT) and SF-12 questionnaires at 4, 8 and 12 weeks' follow-up between the two groups. Significance of the Study's Outcome: The expectation is that this study will add to the body of knowledge required to help patients, healthcare practitioners, policy makers and researchers make effective treatment choices on RSW in the management MFS.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesSaudi Arabia
Collaborators--

Timeline

N/ACompletedFinished
2023202420252026
First PostedMay 19, 2022
Enrollment StartApr 21, 2022
Primary CompletionJul 10, 2023
Study CompletionApr 30, 2024
TodayJul 2, 2026
Enrollment to primary: 1.2 yearsPosted 4.1 years ago

Interventions

Radial shockwave therapydevice

Shockwave Storz Medical device, Doulith SD1, Tower (BT)