ACTRN12623000360617
Recruiting
未知
A Clinical Pilot, Prospective, Participant and Observer-Blinded, Sham-Controlled, Randomised, Dose-Response Study Investigating Focused Ultrasound for Temporary Pain Relief in Moderate-to-Severe Knee Osteoarthritis
Pegasus Neurotechnology0 sites16 target enrollmentApril 12, 2023
Overview
- Phase
- 未知
- Intervention
- Not specified
- Conditions
- Knee Osteoarthritis
- Sponsor
- Pegasus Neurotechnology
- Enrollment
- 16
- Status
- Recruiting
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Adults \>\= 18 years of age with Medicare coverage.
- •2\. Participants with medial knee osteoarthritis, where:
- •a) Knee osteoarthritis is defined according to American College of Rheumatology criteria (knee pain, aching or stiffness on most of the past 30 days and evidence on radiograph of knee osteoarthritis).
- •b) Participants have evidence of disease in the medial compartment on a radiograph, where evidence of disease in the medial compartment in radiographs is defined as at least grade 2 on the Kellgren and Lawrence system.
- •3\) Knee pain of at least 5 out of 10 when performing one of two movements that elicit the worst pain: standing from a seated position and a slow squat (90 degrees).
- •4\) Knee pain is reported in the medial knee as documented on the knee pain map.
- •5\) A diagnostic nerve block of the infrapatellar branch of the saphenous nerve results in a \>\=50% reduction in the NRS pain assessment score in knee pain when performing the activity that elicits the worst pain: standing from a seated position or a slow squat (90 degrees).
- •6\) Stable use of prescription and over\-the\-counter pain medication for \>\=1 month.
- •7\) Ambulatory without assistive devices.
- •8\) An ability to read and speak English fluently.
Exclusion Criteria
- •1\. Planned knee replacement within the next 3 months in the knee to be treated.
- •2\. Viscosupplementation, intra\-articular steroid injection, acupuncture or percutaneous electrical nerve stimulation within the previous 3 months in the knee to be treated.
- •3\. Previous radiofrequency ablation or cryotherapy in the knee to be treated.
- •4\. Prior surgery in the treatment area that may alter the anatomy of the saphenous nerve or result in scar tissue in the skin or soft tissue overlying the treatment area.
- •5\. Prior knee replacement surgery or open knee surgery in the knee to be treated.
- •6\. Prior trauma or fractures within the previous 12 months in the knee to be treated.
- •7\. Open and/or infected wound in the treatment area.
- •8\. Participant reports the majority of knee pain to be outside of the medial aspect of the knee.
- •9\. Use of opioids within the previous 3 months or previous history of opioid abuse.
- •10\. Body Mass Index \>\= 39 kg/m2
Outcomes
Primary Outcomes
Not specified
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