Sustained Acoustic Medicine for Osteoarthritis Pain (NCT05254574) | Clinical Trial Compass
RecruitingPhase 1
Sustained Acoustic Medicine for Osteoarthritis Pain
United States200 participantsStarted 2022-02-14
Plain-language 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.
Who can participate
Age range35 Years – 85 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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).
Exclusion Criteria:
* Cannot successfully demonstrate the ability to put on and take off the device.
* Displays any condition which, in the judgment of…
What they're measuring
1
Change in Pain Units on a Scale (0-10) 0 Being Least, 10 Being Worst Pain From Baseline
Timeframe: Through study completion, average of 8 weeks
2
Change in the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)
Timeframe: Time Frame: Through study completion, average of 8 weeks