Design and Evaluation of a Wearable Self-Applied Therapeutic Ultrasound Device for Chronic Myofascial Pain

Ultrasound therapy for pain and healing is a versatile treatment modality for musculoskeletal conditions that is used daily in rehabilitation clinics around the world. Our group designed and constructed a wearable, battery-operated, low-intensity therapeutic ultrasound (LITUS) device that patients could self-apply and operate during daily activity for up to 6 h. Thirty patients with chronic trapezius myofascial pain evaluated the LITUS system in a double-blind, placebo-controlled, 10-d study under institutional review board approval. While continuing their prescribed medication regimen, patients with the active device reported on average 1.94× reduction in pain and 1.58× improvement in health relative to placebo devices after 1 h of treatment. Both of these results were statistically significant (p < 0.05) for the first 2 d of the study. Male patients reported the majority of benefit, and there is a sex-treatment confound in the sample. The study indicates that wearable, long-duration LITUS technology improves mobile access to drug-free pain relief.