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

NCT05381987 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 70

Last updated 2025-03-17

No results posted yet for this study

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.

Conditions

  • Myofascial Pain Syndrome of Neck

Interventions

DEVICE

Radial shockwave therapy

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

Sponsors & Collaborators

  • King Faisal Specialist Hospital & Research Center

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-04-21
Primary Completion
2023-07-10
Completion
2024-04-30

Countries

  • Saudi Arabia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05381987 on ClinicalTrials.gov