ZetrOZ, Inc.
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.
Osteo Arthritis Knee
Arthritis
Sustained Acoustic Device with 2.5% Diclofenac Patch
Sustained Acoustic Device with 0% Diclofenac Patch
2.5% Diclofenac Patches
SAM Patch
PHASE2
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 completion of treatment. Assessments on quality of life \& function, depression \& anxiety, and sleep will be performed prior to the patient beginning the protocol, at 8 weeks, 16 weeks and at the conclusion of the protocol. Over 300 subjects will be recruited from neighboring communities to the study sites. The study is designed to reach a target patient population which includes rural citizens and socioeconomic disadvantaged individuals.
Study Type : | INTERVENTIONAL |
Estimated Enrollment : | 300 participants |
Masking : | NONE |
Primary Purpose : | TREATMENT |
Official Title : | Sustained Acoustic Medicine for Symptomatic Treatment of Knee Pain Related to Osteoarthritis |
Actual Study Start Date : | 2024-02-19 |
Estimated Primary Completion Date : | 2024-12-31 |
Estimated Study Completion Date : | 2025-02-28 |
Information not available for Arms and Intervention/treatment
Ages Eligible for Study: | 25 Years to 85 Years |
Sexes Eligible for Study: | ALL |
Accepts Healthy Volunteers: | 1 |
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Orthopaedic Foundation
Stamford, Connecticut, United States, 06905
Not yet recruiting
ZetrOZ Systems
Trumbull, Connecticut, United States, 06611
Not yet recruiting
Cayuga Medical Center - Medical Pain Consultants
Dryden, New York, United States, 13053