MedTrace Logo

Sustained Acoustic Medicine (SAM) Combined With a Diclofenac Ultrasound Coupling Patch for Knee Osteoarthritis

NCT04391842 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2023-06-27

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to measure the effectiveness of Sustained Acoustic Medicine (SAM) treatment combined with diclofenac ultrasound coupling gel in patients with stage II and stage III knee osteoarthritis. The ability of the device to reduce pain, increase mobility, increase function of the affected leg, and improve quality of life in patients with knee osteoarthritis will be evaluated.

Conditions

Interventions

COMBINATION_PRODUCT

Sustained Acoustic Device with 1% Diclofenac patch

Patients apply the Sam Ultrasonic Diathermy Device daily for 4 hours of continuous therapeutic ultrasound at 3 megahertz (MHz) frequency and 0.132 Watts/cm2 with 1% diclofenac patch Other Names: * ZetrOZ ultrasound device * wearable ultrasound device * long duration ultrasound * LITUS device * long duration low intensity device

Sponsors & Collaborators

  • ZetrOZ, Inc.

    lead INDUSTRY

Principal Investigators

  • Ralph Ortiz, DO · Medical Pain Consultants

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-09-01
Primary Completion
2019-12-31
Completion
2019-12-31
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 NCT04391842 on ClinicalTrials.gov