CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 200 enrolled
Drug / intervention
2.5% Diclofenac Patches +2 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05882812
NCT05882812Phase 2Completed
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Sustained Acoustic Medicine (SAM) for Symptomatic Treatment of Knee Pain Related to Osteoarthritis

ZetrOZ, Inc.·interventional·Posted May 31, 2023·Updated May 15, 2025

In Brief

A Phase 2 clinical trial evaluating Sustained Acoustic Device with 2.5% Diclofenac Patch, Sustained Acoustic Device with 0% Diclofenac Patch, and 1 other intervention for Osteo Arthritis Knee and Arthritis. Completed, enrolled 200 participants across 3 sites.

Detailed 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 an 8-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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsOsteo Arthritis Knee, Arthritis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
202420252026
First PostedMay 31, 2023
Enrollment StartJun 3, 2023
Primary CompletionDec 31, 2023
Study CompletionFeb 22, 2024
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 3.1 years ago

Interventions

Sustained Acoustic Device with 2.5% Diclofenac Patchdevice

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 Patchdevice

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

2.5% Diclofenac Patchesdrug

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