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Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain

NCT05050448 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2025-05-02

Study results available
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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.

Conditions

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@ with 2.5% Diclofenac patches.

DRUG

1% Diclofenac Topical Gel

Topical pain-relief gel

Sponsors & Collaborators

  • ZetrOZ, Inc.

    lead INDUSTRY

Principal Investigators

  • George K Lewis, Ph.D. · ZetrOZ Systems

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
35 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-08-01
Primary Completion
2022-12-01
Completion
2022-12-31
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05050448 on ClinicalTrials.gov