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Focused Shockwave Therapy for Neck and Shoulder Myofascial Pain

NCT07660523 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-24

No results posted yet for this study

Summary

Myofascial pain syndrome of the neck and shoulder is a common condition characterized by persistent muscle pain, tenderness, stiffness, and limitations in daily activities. Focused extracorporeal shockwave therapy is a noninvasive treatment that may reduce pain and improve muscle function. However, additional clinical evidence is needed regarding the effectiveness of second-generation focused shockwave therapy and whether ultrasound imaging can objectively detect changes in muscle function after treatment.

This pilot randomized controlled trial will enroll 60 adults with chronic neck and shoulder myofascial pain syndrome. Participants will be randomly assigned to either a focused shockwave therapy group or a home-based neck exercise group.

Participants in the focused shockwave therapy group will receive one treatment session per week for three consecutive weeks. Participants in the control group will perform a standardized home exercise program designed to improve neck mobility and reduce muscle tightness.

Assessments will be performed before the intervention, after the intervention, and at follow-up. Study outcomes will include pain intensity measured using the Visual Analogue Scale, neck-related disability measured using the Neck Disability Index, pressure pain threshold measured using an algometer, and upper trapezius muscle thickness and contraction-related changes measured using ultrasound imaging.

The primary objective is to determine whether focused shockwave therapy is more effective than a home-based neck exercise program in reducing pain and improving neck function. The study will also evaluate whether ultrasound-derived muscle measurements are associated with changes in pain, pressure sensitivity, and functional disability.

Conditions

  • Myofascial Pain Syndrome

Interventions

DEVICE

Second-Generation Focused Extracorporeal Shockwave Therapy

Second-generation focused extracorporeal shockwave therapy will be applied to clinically identified tight and painful regions of the upper trapezius and levator scapulae muscles. Treatment will be administered using the Richard Wolf PiezoWave system once weekly for 3 consecutive weeks. Each session will include approximately 3,000 shockwave pulses at a treatment depth of 20 to 25 mm and a frequency of 2 to 4 Hz. The treatment energy level will begin at level 4 and may be gradually increased to a maximum of level 15 according to the participant's clinical response and tolerance.

BEHAVIORAL

Home-Based Neck Exercise Program

Participants will perform a standardized home-based neck exercise program for 3 weeks. The program includes cervical flexion, extension, right and left rotation, right and left lateral flexion, and right and left upper cervical rotation performed with the neck in a flexed position. Each exercise will be performed for 20 repetitions per set, for 3 sets, 5 times per day. Participants will receive initial instruction and movement correction from a qualified physical therapist, together with written educational materials. Adherence and exercise-related difficulties will be monitored during the study.

Sponsors & Collaborators

  • Cishan Hospital, Ministry of Health and Welfare

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-07-13
Primary Completion
2027-04-30
Completion
2027-05-30

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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 NCT07660523 on ClinicalTrials.gov