Radiofrequency Applications and Alcoholic Neurolysis of Genicular Nerve for the Treatment of Knee Osteoarthritic Pain

Not Applicable

Completed

• Conditions: Alcohol; Pain; Genicular Nerve; Radiofrequency; Knee Osteoarthritis
• Interventions: Device: Radiofrequency; Drug: Alcohol 30%; Drug: Alcohol 70%; Drug: Alcohol 50%

• Registration Number: NCT06520384
• Lead Sponsor: Tanta University

Brief Summary

This study aims to investigate the efficacy of radiofrequency ablation and alcoholic neurolysis of genicular nerve on alleviating pain and improving the function of advanced knee osteoarthritis patients.

Detailed Description

Knee osteoarthritis (OA) is a major cause of pain and disability. Patients with moderate to severe knee OA often suffer from excruciating pain with chronic inflammation and reduced range of motion.

Conventional treatment of knee OA includes nonpharmacologic therapies and pharmacologic therapies. Analgesics, low-potency opioids, narcotic analgesics, and nonsteroidal anti-inflammatory drugs (NSAIDs) are commonly used in pharmacologic therapies.

Radiofrequency ablation (RFA) has been used for the treatment of chronic pain that has been unresponsive to conservative therapies. It acts by disrupting the transmission of pain signals using thermal lesion production to interrupt nociceptive signals.

The nerve block is conventionally performed by local anesthesia alone or in combination with corticosteroid. Nerve ablation causes iatrogenic neural degeneration aiming only for sensory or sympathetic denervation without motor deficits. The nerve ablation methods currently available are performed by either thermal ablation using RFA or chemical ablation using alcohol or phenol.

Study Timeline

• Study First Submitted: 2024-07-21
• Study First Submitted QC: 2024-07-21
• Study Start: 2024-07-25
• Study First Posted: 2024-07-25
• Status Verified: 2025-01
• Primary Completion: 2025-01-05
• Study Completion: 2025-01-05
• Last Update Submitted: 2025-01-27
• Last Update Posted: 2025-01-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

• Age > 18 years old.
• Both sexes.
• Patients with knee osteoarthritis.
• Previous conservative treatments longer than 3 months.
• visual analog scale (VAS)≥ 4.
• Radiological osteoarthritis grades 3 and 4 according to the Kellgren-Lawrence grading system (0 = none, 1 = doubtful, 2 = minimal, 3 = moderate, and 4 = severe).

Exclusion Criteria

• Patient refusal.
• History of knee surgery.
• Radiculopathy.
• Anticoagulant therapy.
• Injection with steroids or hyaluronic acids during the previous 3 months.
• Serious neurologic or psychiatric disorders.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Radiofrequency group	Radiofrequency	Patients will receive radiofrequency.
30% alcohol group	Alcohol 30%	Patients will receive ultrasound-guided injection of each of the three genicular nerves with 0.5-0.75 ml of a solution containing 30% alcohol in 0.25% bupivacaine.
70% alcohol group	Alcohol 70%	Patients will receive ultrasound-guided injection of each of the three genicular nerves with 0.5-0.75 ml of a solution containing 70% alcohol in 0.25% bupivacaine.
50% alcohol group	Alcohol 50%	Patients will receive ultrasound-guided injection of each of the three genicular nerves with 0.5-0.75 ml of a solution containing 50% alcohol in 0.25% bupivacaine.

Primary Outcome Measures

Name	Time	Method
Degree of knee pain	6 months postoperative	The degree of knee pain will be assessed using the visual analog scale (VAS). Each patient will obtain a score between 0 and 10 (Zero means no pain, and 10 means the worst pain). VAS will be assessed preoperative and postoperative 1, and 6 months

Secondary Outcome Measures

Name	Time	Method
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores	6 months postoperative	Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC): range from 0 to 96 (0 represents the best health status and 96 the worst possible status). The higher the score, the poorer the function. It will be assessed preoperative and postoperative 1, and 6 months.
Incidence of adverse events	6 months postoperative	Incidence of adverse events such as bleeding, neurological damage, infection, abnormal proprioception, numbness, paresthesia, and motor weakness will be recorded.
Patient satisfaction	6 months postoperative	Degree of patient satisfaction will be assessed on a 5-point Likert scale Patient satisfaction (1, extremely dissatisfied; 2, unsatisfied; 3, neutral; 4, satisfied ; 5, extremely satisfied).

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt