title: Design and evaluation of a wearable self-applied therapeutic ultrasound device for chronic myofascial pain.
abstract: 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.
authors.affiliation: ZetrOZ, INC, Trumbull, CT 06611, USA. george@zetroz.com
authors.forename: George K
authors.initials: GK
authors.lastname: Lewis
authors.forename: Matthew D
authors.initials: MD
authors.lastname: Langer
authors.forename: Charles R
authors.initials: CR
authors.lastname: Henderson
authors.forename: Ralph
authors.initials: R
authors.lastname: Ortiz
mesh_terms: D000328:Adult; D059350:Chronic Pain / Q000517:prevention & control*; D004311:Double-Blind Method; D004867:Equipment Design; D019544:Equipment Failure Analysis; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D008904:Miniaturization; D009209:Myofascial Pain Syndromes / Q000517:prevention & control*; D015990:Placebo Effect; D012648:Self Care / Q000295:instrumentation*; D016896:Treatment Outcome; D014464:Ultrasonic Therapy / Q000295:instrumentation*
keywords: Clinical study; Low-intensity therapeutic ultrasound; Myofascial pain; Outpatient setting; Pain management; Physiotherapy; Therapeutic ultrasound device; Wearable ultrasound device