Sustained Acoustic Medicine for Osteoarthritis Pain
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
2.5% Diclofenac Patches: Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
Study summary
The purpose of this study is to compare Sustained Acoustic Medicine treatment to topical pain relief gel for the symptomatic management of osteoarthritis. The study will measure pain and function scores for patients undergoing treatment.
Eligibility
Primary outcome measure(s)
- Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline — Through study completion, average of 8 weeks
Change in the self described pain units on a scale by patient at baseline and post- - Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) — Time Frame: Through study completion, average of 8 weeks
WOMAC questionnaire will be utilized (Western Ontario and McMaster Universities Arthritis Index) at baseline and post-treatment to calculate the change in scores. WOMAC was divided into 3 categories: pain, stiffness, function and total score. The pain category consists of five scores from 0 - 4, 0 being no pain 4 is worst pain possible, for a range of 0 - 20 points. The stiffness category consists of two scores from 0 - 4, 0 being no stiffness 10 is worst stiffness possible for a range of 0 - 8 points. The function score consists of 17 scores from 0 - 4, 0 being normal function and 10 is severely limited function, for a range of 0 - 68 points. Total score is the sum of pain, stiffness, and function scores (range of 0 - 96).
Trial sites (1)
| Facility | City | Region | Status |
|---|---|---|---|
| James A Haley Veterans Hospital | Tampa | Florida | Recruiting |
More ZetrOZ, Inc. trials in the USA
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT05254574 on ClinicalTrials.gov ↗ ← All trials in the USA