Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis
ZetrOZ, Inc.
Summary
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.
Description
This is a 24-week study to clinically evaluate the effectiveness of the wireless Sustained Acoustic Medicine (SAM) device combined with diclofenac on symptoms of patients suffering from knee osteoarthritis. The class-II device, sam®, has been FDA-cleared for home use. On the first day of the study, baseline data will be collected as patients report pain score before treatment. During the following 24 weeks, patients will self-apply their assigned treatment for the 4 hours daily. Each day of the study, pain scores will be recorded immediately before application of SAM device as well as at the c…
Eligibility
- Age range
- 50–85 years
- Sex
- All
- Healthy volunteers
- Yes
Inclusion Criteria: * 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 50-85 years of age * Report a frequent pain score between 4-7 (range: 0-10) during the week preceding enrollment * Report that knee 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 ultrasound gel provided to the subject at the initiation of the study * Are deemed appr…
Interventions
- DeviceSustained Acoustic Device with 2.5% Diclofenac Patch
Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours of continuous therapeutic ultrasound at 3 megahertz(MHz) frequency and 0.132 Watts/cm\^2 with 2.5% Diclofenac patches.
- DeviceSustained Acoustic Device with 0% Diclofenac Patch
Patients apply the SAM Ultrasonic Diathermy Device daily for 1-4 hours with 0% diclofenac patches.
- Drug2.5% Diclofenac Patches
Topical pain relief-gel worn for 4 hours at least 5 days a week via SAM patch.
- OtherSAM Patch
Ultrasound gel without additional pain relief medication worn for 4 hours at least 5 days a week via SAM patch.
Locations (3)
- Orthopaedic FoundationStamford, Connecticut
- ZetrOZ SystemsTrumbull, Connecticut
- Cayuga Medical Center - Medical Pain ConsultantsDryden, New York