Evaluation of Sustained Acoustic Medicine SAM Device with Diclofenac Patch for Treating Pain from Bone Fractures Over 12 Weeks

What this Trial Is About

Researchers are studying the use of long-duration low-intensity therapeutic ultrasound LITUS combined with a diclofenac patch to relieve pain caused by bone fractures. This study aims to evaluate the pain-relieving effects of this treatment over 12 weeks and also assess whether it helps patients return to work sooner. The study involves adults aged 18 to 80 who have bone fractures and report moderate pain affecting their quality of life. Participants will use the Sustained Acoustic Medicine SAM device, which delivers continuous ultrasound at a specific frequency and intensity, along with a 2.5% diclofenac patch. They will self-apply this treatment for at least 4 hours daily, at least 5 days a week, for a total of 12 weeks. The SAM device is FDA-cleared for home use and emits ultrasound to the affected area to study its pain relief properties. Throughout the study, participants will record their pain levels before, during, and after each treatment session. Researchers will collect baseline data on the first day and monitor changes in pain scores over the 12-week period. The primary outcome is the change in pain intensity measured on a 0 to 10 scale. The study also tracks how the treatment affects patients return to work time. Participants must apply treatment daily at home and avoid other pain treatments during the study period.

Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture