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

Tanta University

Status: Completed

Conditions: Alcohol; Genicular Nerve; Radiofrequency; Pain; Knee Osteoarthritis

Treatments: Drug: Alcohol 30%; Device: Radiofrequency; Drug: Alcohol 70%; Drug: Alcohol 50%

Study type: Interventional

Funder types: Other

Identifiers

NCT06520384

36264PR671/4/24

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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100 participants in 4 patient groups

Radiofrequency group

Experimental group

Description:

Patients will receive radiofrequency.

Treatment:

Device: Radiofrequency

30% alcohol group

Experimental group

Description:

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.

Treatment:

Drug: Alcohol 30%

50% alcohol group

Experimental group

Description:

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.

Treatment:

Drug: Alcohol 50%

70% alcohol group

Experimental group

Description:

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.

Treatment:

Drug: Alcohol 70%