Sustained Acoustic Medicine for Osteoarthritis Pain
ConditionOsteoarthritis
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age35-85
SponsorZetrOZ, Inc.
About this trial
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 criteria
Qualifiers
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
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
- 2.5% Diclofenac Patches
Treatment groups
200 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov