Knee Osteoartritis Genicular Nerve RF Ablation vs Alcohol Neurolysis

NCT07537335 | Not Yet Recruiting

• 1 other identifier: E.567659-139
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

Brief 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.

Conditions

NEUROLYSIS; Knee Osteoarthristis; Radiofrequency Ablation

Outcome Measures

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.

  1 month, 3 months, and 6 months.

Secondary Outcomes (2)

• Change from Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Score

  1 month, 3 months, and 6 months post-procedure.

• Change from Baseline in 12-Item Short Form Health Survey (SF-12) Score.

  1 month, 3 months, and 6 months post-procedure

Study Arms (2)

Genicular Nerve Thermal Radiofrequency Ablation

ACTIVE COMPARATOR

Patients in this group will receive conventional thermal radiofrequency ablation of the superior medial, superior lateral, and inferior medial genicular nerves. The procedure will be performed at 80°C for 90 seconds per site under ultrasound guidance to achieve thermal neurocoagulation.

Other: genicular nerve block

Genicular Nerve Chemical Neurolysis (Alcohol)

EXPERIMENTAL

Patients will receive chemical neurolysis of the superior medial, superior lateral, and inferior medial genicular nerves. 95% ethyl alcohol (1mL per site) will be injected at the target locations to achieve chemical neurodestruction of the sensory nerves.

Other: genicular nerve block

Interventions

genicular nerve block OTHER

Genicular 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.

Also known as: genicular nerve chemical neurolysis, genicular nerve radiofrequency ablation

Genicular Nerve Chemical Neurolysis (Alcohol); Genicular Nerve Thermal Radiofrequency Ablation

Eligibility Criteria

• Age: 45 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Sakarya University: lead

Central Study Contacts

murat erten

CONTACT

+905435118202; muraterten37@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 10, 2026
• First Posted: April 17, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 30, 2026
• Last Updated: April 17, 2026

Record last verified: 2026-04