Knee Osteoartritis Genicular Nerve RF Ablation vs Alcohol Neurolysis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age45-80
SponsorSakarya University
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- genicular nerve block
Treatment groups
50 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov