Radiofrequency Ablation Targeting Femoral Nerve Branches to Treat Chronic Pain After Knee Replacement Surgery
A Randomized, Double-Blind Clinical Trial
Led by Consorci Sanitari de l'Alt Penedès i Garraf · Updated on 2025-12-09
86
Participants Needed
1
Research Sites
65 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are evaluating the use of thermal radiofrequency ablation targeting specific sensory nerves in the knee to treat chronic pain following knee arthroplasty. This randomized double-blind trial aims to determine whether this technique can reduce pain and disability in patients who continue to experience pain at least six months after knee replacement surgery. The study focuses on sensory branches of the femoral nerve, including the infrapatellar branch of the saphenous nerve and the nerves to the medial, intermediate, and lateral vastus muscles, based on recent anatomical findings.
Participants will be randomly assigned to one of two groups. One group will receive thermal radiofrequency ablation applied to the identified sensory nerves using ultrasound and neurostimulation guidance, followed by a local anesthetic injection. The procedure involves heating the nerves for 90 seconds at 80 degrees Celsius using a specialized needle. The control group will undergo the same identification and confirmation process but will receive a sham radiofrequency procedure without actual nerve ablation. Both procedures are designed to be double-blind, so neither participants nor researchers know which treatment is administered.
During the study, participants pain and disability will be assessed primarily using the Western Ontario and McMaster Universities Arthritis Index WOMAC at three months post-treatment. Secondary assessments include pain intensity scales, neuropathic pain questionnaires, anxiety and depression scales, patient satisfaction, and safety monitoring for any adverse events. Participants will be followed closely to evaluate the treatment outcomes and safety over the study period, which aims to capture meaningful improvements in chronic post-knee arthroplasty pain.
CONDITIONS
Brief Title
Radiofrequency Ablation for the Treatment of Post-knee Arthroplasty Chronic Pain.
Research Team
I
ITALO G PISANI, MD
A
ALEJANDRO RODRIGUEZ, PHD
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Chronic knee pain lasting at least 6 months but less than 5 years after the procedure.
Pain intensity of 5 or higher on a 10-point scale.
Stable pain for the last 30 days.
Knee is the joint with the highest pain intensity if multiple joint pains exist.
You will not qualify if you...
Acute knee pain.
Psychiatric illness or dementia that may affect study assessments.
Diagnosis of fibromyalgia, chronic fatigue syndrome, or central sensitization syndrome.
Knee injection with corticosteroids in the past 30 days.
Changes in oral pain medications in the past 30 days.
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - Single treatment session
Participants receive thermal radiofrequency ablation or sham procedure targeting sensory branches of the femoral nerve in the knee to reduce chronic pain after knee arthroplasty.
1 treatment visit (in-person)
Follow-up
Duration - 3 months
Participants are monitored for changes in pain, disability, satisfaction, and safety for 3 months after the treatment.
Follow-up visits over 3 months
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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