NCT05381987

The Effectiveness of Radial Shockwave Therapy on Myofascial Pain Syndrome in Neck and Upper Back.

Completed NA Last updated 17 March 2025

What this trial tests

NA trial testing Radial shockwave therapy in Myofascial Pain Syndrome of Neck in 70 participants. Completed in 30 April 2024.

Timeline

21 April 2022

Primary endpoint
10 July 2023

30 April 2024

Quick facts

Lead sponsor	King Faisal Specialist Hospital & Research Center
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	double
Primary purpose	treatment
Enrollment	70
Start date	21 April 2022
Primary completion	10 July 2023
Estimated completion	30 April 2024
Sites	1 location across Saudi Arabia

Drugs / interventions tested

• Radial shockwave therapy

Conditions studied

• Myofascial Pain Syndrome of Neck — all drugs for Myofascial Pain Syndrome of Neck →

Sponsor

King Faisal Specialist Hospital & Research Center

Who can join

Adults 19 to 80, any sex, with Myofascial Pain Syndrome of Neck. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

1. The effectiveness of radial shockwave therapy on myofascial pain syndrome: a two-armed, randomized double-blind placebo-controlled trial.
   Ogbeivor C, AlMubarak H, Akomolafe T, Alkahtani H, et al · · 2025 · PMID 40275291 · DOI 10.1186/s12891-025-08659-z