Sustained Acoustic Medicine for Osteoarthritis Pain

Status: Recruiting
Location: See location...
Intervention Type: Device, Drug
Study Type: Interventional
Study Phase: Phase 1
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
Participation Requirements
Sex: All
Minimum Age: 35
Maximum Age: 85
Healthy Volunteers: t
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• Have physician-diagnosed mild to moderate knee, shoulder, elbow, ankle, hip, or spine osteoarthritis OA (OARSI atlas grades 1-2) or also referred to as Degenerative Joint Disease (DJD).

• Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA

• Are between 35-85 years of age

• Report a frequent pain score between 3-7 (range: 0-10) during the week preceding enrollment

• Report that knee, shoulder, elbow, ankle, hip, or spine pain negatively affects quality of life

• Are willing not to use any cream, gel, or topical solution during the administration of treatment other than the approved treatment provided to the subject at the initiation of the study

• Are deemed appropriate by their physician or by the study site physician to participate.

• Be willing and able to self-administer treatment daily within their place of residence or during normal daily activity, excluding bathing, showering, or other water activities which may result in submersion of the study device.

• Not use or initiate opioid and/or non-opioid analgesic medications.

• Be willing to discontinue any other interventional treatment modalities on the treatment area during the study period (e.g., transcutaneous electrical nerve stimulation, electronic muscle stimulation, traditional ultrasound).

Locations
United States
Florida
James A Haley Veterans Hospital
RECRUITING
Tampa
Contact Information
Primary
George K. Lewis, Ph.D.
george@zetroz.com
888-202-9831
Time Frame
Start Date: 2022-02-14
Estimated Completion Date: 2026-05-31
Participants
Target number of participants: 200
Treatments
Experimental: SAM Ultrasound Device and Diclofenac Patch
Patients receive treatment from the wired SAM Ultrasonic Diathermy Device for 4 hours at least 5 days a week for 8 weeks combined with 2.5% diclofenac patch. The SAM device emits continuous ultrasound at 3 megahertz (MHz) frequency and 0.132 watts/cm2 intensity.
Related Therapeutic Areas
Sponsors
Leads: ZetrOZ, Inc.

This content was sourced from clinicaltrials.gov