Status:
COMPLETED
Long-Duration Ultrasound for Knee Osteoarthritis
Lead Sponsor:
ZetrOZ, Inc.
Conditions:
Osteo Arthritis Knee
Eligibility:
All Genders
18-80 years
Phase:
NA
Brief Summary
This study will measure the 24-week pain relief from long-duration ultrasound on the symptoms of knee arthritis pain.
Eligibility Criteria
Inclusion
- Are you between 18 and 80 years of age (inclusive)?
- Can you speak, read, and write in English?
- Do you have knee pain that has lasted at least 3 months?
- Are you willing and able to self-administer the ultrasound device daily within your place of residence or during normal daily activity?
- Are you willing to keep all pain medications stable and discuss with the investigator any needs to change medications during the study period? This may include drugs administered topically, orally, transdermally, or by injection.
- Are you willing to document usage of any medications during the study period?
- Do you agree to discontinue all other interventional treatment modalities on the lower back during the study? (e.g., transcutaneous electric nerve stimulation \[TENS\], electronic muscle stimulation, traditional ultrasound, massage therapy, chiropractic services)
- On a Numeric Rating Scale (NRS) of 0 (no pain) to 10 (pain as bad as you can imagine), how would you rate your average pain over the past week? Pain must be ≥4 for the subject to be enrolled in this study. This criterion will be assessed by self-report at Visit 1.
Exclusion
- Have you participated in a clinical trial for an investigational drug and/or agent within 30 days prior to screening?
- Are you pregnant?
- Are you a prisoner?
- Are you non-ambulatory (unable to walk)?
- Do you have a pacemaker?
- Do you have a malignancy in the treatment area?
- Do you have an active infection, open sores, or wounds in the treatment area?
- Do you have impaired sensation in the treatment area, such as caused by chemotherapy or anesthesia?
- Do you have a known neuropathy (disease of the brain or spinal nerves)?
- Do you have a hereditary disposition (tendency) for excessive bleeding (hemorrhage)?
- Do you have peripheral artery disease?
- Does the subject display 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?
Key Trial Info
Start Date :
January 1 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2019
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03800927
Start Date
January 1 2017
End Date
June 1 2019
Last Update
June 26 2023
Active Locations (2)
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1
Orthopedic Foundation
Stamford, Connecticut, United States, 06905
2
Medical Pain Consultants
Dryden, New York, United States, 13053