Trials / Completed
CompletedNCT05050448
Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for OA Knee Pain
Comparative Usability Evaluation of Sustained Acoustic Medicine (SAM) Devices and Topical Gel for Knee Pain Related to Osteoarthritis
- Status
- Completed
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 60 (actual)
- Sponsor
- ZetrOZ, Inc. · Industry
- Sex
- All
- Age
- 35 Years – 80 Years
- Healthy volunteers
- Accepted
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
| Type | Name | Description |
|---|---|---|
| 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 |
Timeline
- Start date
- 2021-08-01
- Primary completion
- 2022-12-01
- Completion
- 2022-12-31
- First posted
- 2021-09-20
- Last updated
- 2025-05-02
- Results posted
- 2025-05-02
Locations
3 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT05050448. Inclusion in this directory is not an endorsement.