Long Duration High Frequency Ultrasound for the Treatment of Osteoarthritis
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age65-85
SponsorZetrOZ, Inc.
About this trial
The purpose of this study is to assess the ability of long-duration high-frequency continuous-wave therapeutic ultrasound to alleviate knee Osteoarthritis pain over an 12-week period. The primary objective of this study is to evaluate the analgesic effect of ultrasound treatment in subjects suffering from knee Osteoarthritis pain. Secondary objectives are to assess the ability of ultrasound treatment to improve joint function.
Eligibility criteria
Qualifiers
Have physician-diagnosed mild to moderate knee OA (OARSI atlas grades 1-2)
Fulfill the American College of Rheumatology clinical and radiological diagnostic criteria for knee OA
Are between 65-85 years of age
Report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment
Disqualifiers
Cannot successfully demonstrate the ability to put on and take off the device.
Displays any condition which, in the judgment of the investigator, would make participation in the study unacceptable including, but not limited to, the subject's ability to understand and follow instructions.
Participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening.
Is pregnant.
Trial design
Treatments tested in this trial
- Sustained Acoustic Device with 2.5% Diclofenac Patch
- Sustained Acoustic Device with 0% Diclofenac Patch
- Intra articular injection
Treatment groups
240 Participants
are divided into 3 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov