Knee Osteoartritis Genicular Nerve RF Ablation vs Alcohol Neurolysis
Not yet recruitingNot applicableNCT07537335
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
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.
Study details
- Official title
- Comparison of Genicular Nerve Radiofrequency Ablation and Neurolytic Alcohol Injection for Chronic Knee Osteoarthritis Pain: A Randomized Controlled Trial
- Conditions
- Knee Osteoarthristis
- Radiofrequency Ablation
- Neurolysis
- Interventions
- Other: genicular nerve block
- Sponsor
- Sakarya University
- Start date
- 2026-05-01
- Primary completion
- 2026-12-01
- Sex
- All
- Age range
- from 45 Years to 80 Years
- Results posted
- No results posted in this snapshot
- Total sites listed
- 0
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
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).
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07537335