Knee Osteoartritis Genicular Nerve RF Ablation vs Alcohol Neurolysis
50 participantsStarted 2026-05-01
Plain-language summary
The GEN-AL-RF study is a randomized controlled trial designed to compare the clinical efficacy of two interventional techniques for managing chronic knee pain due to osteoarthritis. The study focuses on genicular nerve radiofrequency (RF) ablation versus neurolytic alcohol injection for pain blockade.
Patients diagnosed with knee osteoarthritis are randomly assigned to either the RF ablation group or the neurolytic alcohol group. The primary objective is to evaluate the superiority and duration of analgesic effects between these two methods. Clinical outcomes are assessed at baseline and at 1, 3, and 6 months post-procedure using the Numeric Rating Scale (NRS) for pain intensity, the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) for physical function, and the Short Form-12 (SF-12) for health-related quality of life.
The results of this study aim to provide high-quality evidence regarding the comparative effectiveness and long-term outcomes of genicular nerve RF and alcohol neurolysis in the clinical management of chronic knee osteoarthritis pain.
Who can participate
Age range
45 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Age: Patients aged 45 to 85 years.
* Diagnosis: Chronic knee pain for at least 6 months diagnosed with knee osteoarthritis according to American College of Rheumatology (ACR) criteria.
* Radiological Grade: Grade 3 or 4 according to the Kellgren-Lawrence (K-L) classification.
* Pain Severity: Baseline Numerical Rating Scale (NRS) score of 5 or higher.
* Failure of Conservative Treatment: Inadequate response to conservative treatments (e.g., physical therapy, NSAIDs, or intra-articular injections) for at least 3 months.
* Positive Diagnostic Block: At least 50% reduction in pain for minimum 24 hours following a prognostic genicular nerve block with local anesthetic.
Exclusion Criteria:
* Previous Surgery: History of knee arthroplasty or major knee surgery on the affected side.
* Specific Conditions: Presence of inflammatory arthritis (e.g., rheumatoid arthritis), gouty arthritis, or active infection at the injection site.
* Neurological Deficit: Severe neurological or psychiatric disorders that may interfere with pain assessment.
* Coagulopathy: Uncontrolled bleeding disorders or use of anticoagulant therapy that cannot be temporarily discontinued.
* Recent Injections: Intra-articular steroid or hyaluronic acid injection within the last 3 months.
* Allergy: Known allergy to local anesthetics, contrast agents, or ethyl alcohol.
* Pacemaker: Presence of a cardiac pacemaker or implanted electronic device (specifically for the RFA group).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Numeric Rating Scale (NRS) Score at 6 Months.