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Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Pain Related to Bone Fracture
Sponsor: ZetrOZ, Inc.
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.
Key Details
Gender
All
Age Range
18 Years - 80 Years
Study Type
INTERVENTIONAL
Enrollment
90
Start Date
2023-06-01
Completion Date
2026-02-28
Last Updated
2025-02-28
Healthy Volunteers
Yes
Conditions
Interventions
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.
2.5% Diclofenac Patches
Topical pain relief-gel worn during treatment via SAM patch.
Locations (2)
ZetrOZ Systems LLC
Trumbull, Connecticut, United States
National Sports Medicine Institute
Lansdowne, Virginia, United States