Study of Low-Energy Ultrasound, Electrical and Magnetic Stimulation Device for Adults with Chronic Therapy-Resistant Myofascial Pain Syndrome

What this Trial Is About

Researchers are evaluating the use of Sonodyn, an investigational handheld medical device, for adults suffering from therapy-resistant myofascial pain syndrome causing low back pain, tension headache, or neck pain. This condition is a common cause of muscle pain and dysfunction, characterized by trigger points in muscles. The study is a randomized, double-blind, sham-controlled trial conducted at multiple sites in Austria and Switzerland to assess the devices impact on pain levels. The study compares active Sonodyn therapy, which delivers low-energy ultrasound, electrical, and magnetic stimulation to targeted trigger points, with a sham device that looks identical but does not deliver any stimulation. Patients undergo treatment for three weeks, activating their assigned device three times daily for 10 minutes each session. The trial includes a one-week screening phase before treatment and an eight-week follow-up period after treatment, totaling 12 weeks of participation. Participants report their average and maximum pain intensity twice daily using a Numeric Rating Scale throughout screening, treatment, and follow-up periods. They also track the use of any rescue medication. Researchers will measure pain changes as the primary outcome and assess additional factors such as medication use, quality of sleep, and quality of life. The study monitors compliance and safety while comparing results between active therapy and sham control groups.

Low-Energy Ultrasound, Electrical and Magnetic Field Stimulation in Therapy-Resistant Myofascial Pain Syndrome