Focused Shockwave Therapy for Neck and Shoulder Myofascial Pain (NCT07660523) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Focused Shockwave Therapy for Neck and Shoulder Myofascial Pain
60 participantsStarted 2026-07-13
Plain-language 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.
Who can participate
Age range
20 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Adults older than 20 years.
* Clinical diagnosis of nonspecific neck and shoulder pain primarily arising from muscles and soft tissues in the upper trapezius or levator scapulae region, as determined by a physical medicine and rehabilitation physician.
* Neck and shoulder pain lasting for at least 3 months.
* Neck Disability Index score greater than 5.
* No use of analgesic medication or muscle relaxants within the previous month.
* No injection therapy, physical therapy, or other treatment for neck and shoulder pain within the previous month.
* Ability to understand the study procedures and provide written informed consent.
Exclusion Criteria:
* Neck or shoulder pain caused by a neurologic disorder, including cervical radiculopathy.
* Clinical or imaging diagnosis of cervical degenerative joint disease.
* History of a rheumatic disease, including rheumatoid arthritis or systemic lupus erythematosus.
* History of head or neck trauma.
* History of cervical spine surgery.
* History of whiplash injury.
* Pregnancy.
* Current or previous malignancy considered clinically relevant to shockwave therapy.
* Bleeding disorder.
* Current use of anticoagulant medication, including warfarin.
* Acute inflammation or infection at the treatment site.
* Implanted cardiac pacemaker or implantable cardioverter-defibrillator.
* Any other condition judged by the study physician to make participation or focused shockwave therapy inappropriate or unsafe.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Neck and Shoulder Pain Intensity
Timeframe: Baseline, immediately after completion of the 3-week intervention, and Week 8 after enrollment
2
Change in Pressure Pain Threshold
Timeframe: Baseline, immediately after completion of the 3-week intervention, and Week 8 after enrollment
Trial details
NCT IDNCT07660523
SponsorCishan Hospital, Ministry of Health and Welfare