NCT05883241

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

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: ZetrOZ, Inc. · Industry
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

Summary

The purpose of this study is to assess the ability of long-duration low-intensity therapeutic ultrasound (LITUS) to alleviate bone-fracture related pain over a 12-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from bone-fracture pain. Secondary objectives are to assess the ability of LITUS to improve patients return to work time.

Detailed description

This is a 12-week study to clinically evaluate the effectiveness of the Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from pain related to a bone fracture(s). The class-II device, sam®, has been FDA-cleared for home use. On the first day of the study, baseline data will be collected as patients report pain score before treatment. During the following 12 weeks, patients will self-apply their treatment for the 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device, during treatment, and at the completion of treatment. Over 90 subjects will be recruited from neighboring communities to the study site(s). The study is designed to reach a diverse target patient population.

Conditions

• Bone Fracture
• Fresh Fracture

Interventions

Type	Name	Description
DEVICE	Sustained Acoustic Device with 2.5% Diclofenac Patch	Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3-megahertz (MHz) frequency and 0.132 Watts/cm\^2 with 2.5% Diclofenac patches.
DRUG	2.5% Diclofenac Patches	Topical pain relief-gel worn during treatment via SAM patch.

Timeline

• Start date: 2023-06-01
• Primary completion: 2026-02-01
• Completion: 2026-02-28
• First posted: 2023-05-31
• Last updated: 2025-02-28

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study