Focused Shockwave Therapy for Neck and Shoulder Myofascial Pain
Recruiting · NCT07660523 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
What this trial is about
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 take part
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.
Where it is running
1 location listed.
- CiShan hospital, Ministry of Health and Welfare - Kaohsiung City, Taiwan