Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis

PHASE2CompletedINTERVENTIONAL
Enrollment

200

Participants

Timeline

Start Date

June 3, 2023

Primary Completion Date

December 31, 2023

Study Completion Date

February 22, 2024

Conditions
Osteo Arthritis KneeArthritis
Interventions
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.

DEVICE

Sustained Acoustic Device with 0% Diclofenac Patch

Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.

DRUG

2.5% Diclofenac Patches

Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.

Trial Locations (3)

13053

Cayuga Medical Center - Medical Pain Consultants, Dryden

06905

Orthopaedic Foundation, Stamford

06611

ZetrOZ Systems, Trumbull

All Listed Sponsors
lead

ZetrOZ, Inc.

INDUSTRY

NCT05882812 - Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis | Biotech Hunter | Biotech Hunter