NCT06257537

Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 300 (estimated)
• Sponsor: ZetrOZ, Inc. · Industry
• Sex: All
• Age: 50 Years – 85 Years
• Healthy volunteers: Accepted

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 a 24-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.

Detailed description

This is a 24-week study to clinically evaluate the effectiveness of the wireless Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from knee osteoarthritis. The class-II device, sam®, has been FDA-cleared for home use. On the first day of the study, baseline data will be collected as patients report pain score before treatment. During the following 24 weeks, patients will self-apply their assigned treatment for the 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device as well as at the completion of treatment. Assessments on quality of life \& function, depression \& anxiety, and sleep will be performed prior to the patient beginning the protocol, at 8 weeks, 16 weeks and at the conclusion of the protocol. Over 300 subjects will be recruited from neighboring communities to the study sites. The study is designed to reach a target patient population which includes rural citizens and socioeconomic disadvantaged individuals.

Conditions

• Osteo Arthritis Knee
• Arthritis

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\^2 with 2.5% Diclofenac patches.
DEVICE	Sustained Acoustic Device with 0% Diclofenac Patch	Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
DRUG	2.5% Diclofenac Patches	Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
OTHER	SAM Patch	Ultrasound gel without additional pain relief medication worn for 4 hours at least 5 days a week via SAM patch.

Timeline

• Start date: 2024-10-01
• Primary completion: 2026-02-01
• Completion: 2026-02-28
• First posted: 2024-02-14
• Last updated: 2025-03-06

Locations

3 sites across 1 country: United States

Regulatory

• FDA-regulated drug study
• FDA-regulated device study