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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
genicular nerve block
Other interventionGenicular nerve radiofrequency ablation : Patients will undergo ultrasound or fluoroscopy-guided radiofrequency ablation of the genicular nerves (superior medial, superior lateral, and inferior medial). The procedure involves placing RF cannulas at the target neural sites. Once the position is confirmed by sensory and motor stimulation, thermal radiofrequency lesioning will be performed to disrupt pain signal transmission. Genicular nerve chemichal neurolysis: Patients will receive ultrasound or fluoroscopy-guided chemical neurolysis of the genicular nerves (superior medial, superior lateral, and inferior medial). Following correct needle placement confirmed by contrast spread or local anesthetic test block, a specific volume (1 mL per nerve) of ethyl alcohol (95-96% concentration) will be injected to achieve long-term neurolytic blockade of the target nerves.
Treatment groups
50 Participants
are divided into 2 treatment groupsGroup A: Genicular Nerve Thermal Radiofrequency AblationActive comparator 1 intervention
Group B: Genicular Nerve Chemical Neurolysis (Alcohol)Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change from Baseline in Numeric Rating Scale (NRS) Score at 6 Months.
The Numeric Rating Scale (NRS) is a segmented numerical version of the visual analog scale in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of their pain. The score ranges from 0 (no pain) to 10 (worst possible pain). A decrease in score indicates pain relief.
Time frame
1 month, 3 months, and 6 months.Secondary outcomes
1
Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score
The WOMAC is a proprietary set of standardized questionnaires used to evaluate the condition of patients with osteoarthritis of the knee and hip, including segments for pain, stiffness, and physical function. Higher scores indicate worse outcomes.
Time frame
1 month, 3 months, and 6 months post-procedure.2
Change from Baseline in 12-Item Short Form Health Survey (SF-12) Score.
The SF-12 is a self-reported outcome measure assessing health-related quality of life. It yields two summary scores: the Physical Component Summary (PCS) and the Mental Component Summary (MCS). Higher scores indicate better physical and mental health.
Time frame
1 month, 3 months, and 6 months post-procedureLocations
Sponsors and contacts
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Source ClinicalTrials.gov
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