RecruitingPhase 2NCT06257537

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


Sponsor

ZetrOZ, Inc.

Enrollment

300 participants

Start Date

Oct 1, 2024

Study Type

INTERVENTIONAL

Conditions

Summary

The purpose of this study is to assess the ability of long-duration low intensity therapeutic ultrasound (LITUS) to alleviate knee Osteoarthritis pain over a 24-week period. The primary objective of this study is to evaluate the analgesic effect of LITUS in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of LITUS to improve joint function.


Eligibility

Min Age: 50 YearsMax Age: 85 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 2.5% Diclofenac Patches, SAM Patch, and others for people with arthritis and osteo arthritis knee. The study is currently recruiting participants at 3 locations.

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\^2 with 2.5% Diclofenac patches.

DEVICESustained Acoustic Device with 0% Diclofenac Patch

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

DRUG2.5% Diclofenac Patches

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

OTHERSAM Patch

Ultrasound gel without additional pain relief medication worn for 4 hours at least 5 days a week via SAM patch.


Locations(3)

Orthopaedic Foundation

Stamford, Connecticut, United States

ZetrOZ Systems

Trumbull, Connecticut, United States

Cayuga Medical Center - Medical Pain Consultants

Dryden, New York, United States

View Full Details on ClinicalTrials.gov

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NCT06257537


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