300
Participants
Start Date
October 1, 2024
Primary Completion Date
February 1, 2026
Study Completion Date
February 28, 2026
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.
Sustained Acoustic Device with 0% Diclofenac Patch
Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
2.5% Diclofenac Patches
Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
SAM Patch
Ultrasound gel without additional pain relief medication worn for 4 hours at least 5 days a week via SAM patch.
RECRUITING
Cayuga Medical Center - Medical Pain Consultants, Dryden
RECRUITING
Orthopaedic Foundation, Stamford
RECRUITING
ZetrOZ Systems, Trumbull
ZetrOZ, Inc.
INDUSTRY