Actively Recruiting
Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
Led by ZetrOZ, Inc. · Updated on 2025-03-06
300
Participants Needed
3
Research Sites
73 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Have physician-diagnosed mild to moderate knee osteoarthritis (OARSI atlas grades 1-2)
- Meet American College of Rheumatology clinical and radiological criteria for knee osteoarthritis
- Are between 50 and 85 years old
- Have frequent knee pain score between 4 and 7 (on a 0-10 scale) during the week before enrollment
- Report that knee pain negatively affects your quality of life
- Are willing not to use any other creams, gels, or topical solutions except the ultrasound gel provided
- Are deemed appropriate by a physician to participate
- Are willing and able to self-administer treatment daily at home or during normal activities, excluding water activities
- Do not use or start opioid or non-opioid pain medications
- Are willing to stop any other knee treatments during the study (like electrical stimulation or traditional ultrasound)
You will not qualify if you...
- Cannot show the ability to put on and take off the study device
- Have any condition making it unsafe or unsuitable to participate as judged by the investigator
- Participated in a clinical trial for an investigational drug or agent within 30 days before screening
- Are pregnant
- Are a prisoner
- Are unable to walk (non-ambulatory)
- Have a pacemaker
- Have cancer 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., from chemotherapy or anesthesia)
- Have known nerve disease (neuropathy)
- Have a hereditary tendency for excessive bleeding
- Had knee replacement, surgery, or hyaluronidase injection in the affected knee within the past 6 months
- Are currently taking steroids
- Have any reason you cannot have X-rays
- Have arthritis caused by metabolic or inflammatory conditions (secondary arthritis)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Orthopaedic Foundation
Stamford, Connecticut, United States, 06905
Actively Recruiting
2
ZetrOZ Systems
Trumbull, Connecticut, United States, 06611
Actively Recruiting
3
Cayuga Medical Center - Medical Pain Consultants
Dryden, New York, United States, 13053
Actively Recruiting
Research Team
G
George K Lewis, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
4
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