CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
1% Diclofenac Topical Gel +1 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/NCT05050448
NCT05050448Phase 2Completed
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Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for Knee Pain Related to Osteoarthritis

ZetrOZ, Inc.·interventional·Posted Sep 20, 2021·Updated May 2, 2025

In Brief

A Phase 2 clinical trial evaluating Sustained Acoustic Device with 2.5% Diclofenac Patch and 1% Diclofenac Topical Gel for Knee Osteoarthritis. Completed, enrolled 60 participants across 3 sites.

Detailed Summary

The purpose of this study is to evaluate the usability of the ultrasound devices and common pain relief gel. The ability of the three treatment approaches to reduce pain, stiffness, and functionality as measured by NRS scale and the Western Ontario and McMaster Universities Arthritis Index (WOMAC) will be evaluated.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKnee Osteoarthritis
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedSep 20, 2021
Enrollment StartAug 1, 2021
Primary CompletionDec 1, 2022
Study CompletionDec 31, 2022
TodayJul 2, 2026
Enrollment to primary: 1.3 yearsPosted 4.8 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@ with 2.5% Diclofenac patches.

1% Diclofenac Topical Geldrug

Topical pain-relief gel