Actively Recruiting
Sustained Acoustic Medicine for Osteoarthritis Pain
Led by ZetrOZ, Inc. · Updated on 2025-02-27
200
Participants Needed
1
Research Sites
223 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sustained Acoustic Medicine for Osteoarthritis Pain
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have physician-diagnosed mild to moderate knee, shoulder, elbow, ankle, hip, or spine osteoarthritis (OARSI atlas grades 1-2) or Degenerative Joint Disease
- Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee osteoarthritis
- Are between 35 and 85 years of age
- Report a frequent pain score between 3 and 7 (on a 0-10 scale) during the week before 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 treatment other than the approved study treatment
- Are deemed appropriate by their physician or study site physician to participate
- Are willing and able to self-administer treatment daily at home or during normal daily activity, excluding water activities that submerge the device
- Do not use or start opioid or non-opioid analgesic medications
- Are willing to stop any other interventional treatments on the affected area during the study (e.g., electrical nerve stimulation, muscle stimulation, traditional ultrasound)
You will not qualify if you...
- Cannot demonstrate the ability to put on and take off the study device
- Have any condition that makes participation unacceptable, including inability to understand or follow instructions
- Participated in a clinical trial for an investigational drug or agent within 30 days before screening
- Are pregnant
- Are a prisoner
- Have a pacemaker
- Have malignancy in the treatment area
- Have an active infection, open sores, or wounds in the treatment area
- Have impaired sensation in the treatment area (e.g., due to chemotherapy or anesthesia)
- Have a known neuropathy affecting brain or spinal nerves
- Have a hereditary tendency for excessive bleeding
- Have had knee, shoulder, elbow, ankle, or hip replacement or other surgery in the affected area within the past 6 months
- Require oxygen support
- Have an allergy to aspirin or other NSAIDs
- Have a secondary cause of arthritis such as metabolic or inflammatory arthritis
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
James A Haley Veterans Hospital
Tampa, Florida, United States, 33511
Actively Recruiting
Research Team
G
George K. Lewis, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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