RecruitingPhase 1NCT05254574

Sustained Acoustic Medicine for Osteoarthritis Pain


Sponsor

ZetrOZ, Inc.

Enrollment

200 participants

Start Date

Feb 14, 2022

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.


Eligibility

Min Age: 35 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This study is comparing Sustained Acoustic Medicine (SAM), a wearable ultrasound device worn on the skin, to a topical pain relief gel for managing joint pain caused by osteoarthritis. Researchers are measuring how much pain relief and improvement in function each treatment provides over the study period. You may be eligible if you are 35 to 85 years old, have mild to moderate osteoarthritis of the knee, shoulder, elbow, ankle, hip, or spine diagnosed by a physician, and report pain that regularly affects your quality of life. Participation involves self-administering your assigned treatment daily at home and not using other interventional pain treatments during the study period. This summary was prepared using AI to help patients understand this research.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICESustained 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@ with 2.5% Diclofenac patches.

DRUG2.5% Diclofenac Patches

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


Locations(1)

James A Haley Veterans Hospital

Tampa, Florida, United States

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NCT05254574


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