The epidemiology, etiology, diagnosis, and treatment of osteoarthritis of the knee.
Joern W-P Michael, Klaus U Schlüter-Brust, Peer Eysel
https://pubmed.ncbi.nlm.nih.gov/20305774Actively Recruiting
Phase Not Applicable
Age: 30Years - 75Years
All Genders
ID06914960
Ultrasound-Guided Genicular Nerve Radiofrequency Ablation Therapy Comparing 5-Nerve, 3-Nerve, and 2-Nerve Protocols for Knee Osteoarthritis: A Randomized Controlled Study
Led by Bengu Turemenogullari · Updated on 2025-04-09
66
Participants Needed
1
Research Sites
17 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are investigating the effectiveness and long-term benefits of radiofrequency ablation (RFA) therapy targeting different numbers of nerves to treat chronic knee pain caused by osteoarthritis. This condition, which results from joint cartilage damage with age, leads to pain, loss of balance, and increased fall risk due to impaired knee proprioception. The study aims to compare RFA applied to 5 nerves, 3 nerves, or 2 nerves to understand which protocol best improves pain, balance, proprioception, and symptoms in knee osteoarthritis. Participants will undergo a diagnostic genicular nerve block to confirm suitability before receiving RFA treatment under ultrasound guidance. Patients are randomly assigned to one of three groups receiving a single RFA session targeting either 2 nerves (superior medial and inferior medial), 3 nerves (superior medial, superior lateral, and inferior medial), or 5 nerves (including the previous three plus recurrent fibular nerve and infrapatellar branch of the saphenous nerve). The procedure uses precise ultrasound and electrical stimulation to locate nerves and applies pulsed radiofrequency at 42°C for 120 seconds per nerve, followed by an injection of betamethasone and lidocaine to reduce discomfort. Participants will be evaluated at baseline, 1 month, and 3 months after treatment. Assessments include muscle strength tests of the quadriceps and hamstrings, knee joint proprioception measurements, balance and coordination tests (such as Romberg and Single Leg Tests), walking ability, fall risk scales, and quality of life questionnaires. Patients will continue their usual medication and exercise but avoid other knee pain treatments for 3 months. The study monitors safety and effectiveness through these measures over the course of the trial.
CONDITIONS
Brief Title
Efficacy of Ultrasound-Guided Genicular Nerve Radiofrequency Ablation Therapy
Who Can Participate
Age: 30Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age between 30 and 75 years
- Chronic knee pain lasting at least 6 months
- Radiographic confirmation of osteoarthritis with Grade 3 or 4 changes in the medial tibiofemoral joint
- Knee pain over 40 mm on a 100 mm visual analog scale during sitting to standing or going up/down stairs
- At least 50% pain reduction following diagnostic genicular nerve block
You will not qualify if you...
- Presence of systemic inflammatory diseases such as rheumatoid arthritis
- Previous radiofrequency ablation treatment or knee injection (hyaluronic acid or steroids) within last 3 months
- History of previous knee surgery
- Significant structural knee abnormalities other than osteoarthritis
- Physical therapy for the knee in last 6 months or history of knee trauma
- Current use of other pain treatments
- Body mass index less than 18 or greater than 40 kg/m2
- Pregnancy
- Presence of uncontrolled serious illnesses, infections, psychiatric disorders, or coagulation disorders
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Diagnostic Evaluation
Duration - 1 day
Participants receive a diagnostic genicular nerve block to assess pain reduction before the main treatment.
1 visit (in-person)
Treatment
Duration - 1 day
Participants receive a single session of radiofrequency ablation therapy targeting either 2, 3, or 5 genicular nerves to reduce knee pain and improve function.
1 visit (in-person)
Follow-up
Duration - 3 months
Participants are monitored for treatment effects on pain, balance, proprioception, and physical performance over 3 months.
Visits at baseline, 1 month, and 3 months post-treatment
Trial Site Locations
Total: 1 location
1
Ankara Etlik City Hospital, Physical Medicine and Rehabilitation
Ankara, Ankara, Turkey (Türkiye)
Actively Recruiting
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Research Team
B
Bengu Turemenogullari
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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