None listed
Conditions
Brief summary
The study aim is to explore the possibility of treating knee pain with focused ultrasound, optimise the study protocol and estimate the treatment effect in preparation for developing a subsequent clinical trial.
Interventions
Focused ultrasound (focused ultrasound energy) will be transcutaneously applied to the saphenous nerve under imaging ultrasound guidance in participants with moderate-to-severe knee osteoarthritis. The procedure will occur only once in an outpatient clinic and be completed by a sports medicine physician. It will take approximately 10-15 minutes.
This is a dose-response study, where participants will be randomised to one of four cohorts of four subjects each (9W, 18W, 27W) and the degree and du
Focused ultrasound (focused ultrasound energy) will be transcutaneously applied to the saphenous nerve under imaging ultrasound guidance in participants with moderate-to-severe knee osteoarthritis. The procedure will occur only once in an outpatient clinic and be completed by a sports medicine physician. It will take approximately 10-15 minutes. This is a dose-response study, where participants will be randomised to one of four cohorts of four subjects each (9W, 18W, 27W) and the degree and duration of pain relief assessed on a per-cohort basis. Each participant within a cohort will receive the same dose.
Sponsors
Pegasus Neurotechnology
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
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. 9) Willing and able to sign a written informed consent document. 10) Willing and able to comply with study instructions and commit to all follow-up requirements for the duration of the study. 11) In good general health and free of any systemic disease or physical condition that might impair evaluation or which in the Investigator’s opinion, exposes the participant to an unacceptable risk by study participation.
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 11. Saphenous nerve is: a) Not visible on ultrasound, OR b) Not accessible with the device, OR c) Larger in cross-sectional area compared to the focused ultrasound focal region. 12. Concomitant inflammatory disease or other condition which affects joints (e.g. rheumatoid arthritis, metabolic bone disease, gout, active infection). 13. Concomitant skin conditions at the treatment site that in the Investigator’s opinion would adversely affect treatment or outcomes. 14. Part of another trial testing other investigational devices for knee pain or analgesic agents. 15. Life expectancy of <12 months. 16. Pacemakers or other life-sustaining devices. 17. Current or previous artery aneurysm or stent in the intended treatment region. 18. Any chronic medical condition or chronic medication use that in the Investigator’s opinion would affect study participation or safety. 19. Any other reason in the opinion of the Investigator that the participant may not be a suitable candidate for study participation (i.e. history of non-compliance, drug dependency, etc.). 20. Employees, relatives or students with ties to any of the investigators or sponsor. 21. Femoral artery plaque adjacent to the target nerve region on imaging ultrasound.
Outcome results
None listed