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NCT Number: NCT06520384

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

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.

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Key information

Conditions

Radiofrequency Alcohol Arthritis Genicular Nerve Joint Diseases Knee Osteoarthritis Musculoskeletal Diseases Neurologic Manifestations Osteoarthritis Osteoarthritis, Knee Pain Pathological Conditions, Signs and Symptoms Rheumatic Diseases Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Radiofrequency

Device

Patients will receive radiofrequency.

Alcohol 30%

Drug

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.

Alcohol 50%

Drug

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.

Alcohol 70%

Drug

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.

Primary outcomes

  1. Degree of knee pain

    Time frame: 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 outcomes

  1. Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores

    Time frame: 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.

  2. Patient satisfaction

    Time frame: 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).

  3. Incidence of adverse events

    Time frame: 6 months postoperative

    Incidence of adverse events such as bleeding, neurological damage, infection, abnormal proprioception, numbness, paresthesia, and motor weakness will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

Comparison of Radiofrequency Applications and Alcoholic Neurolysis of Genicular Nerve for the Treatment of Knee Osteoarthritic Pain: A Randomized Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 25, 2024
Registry last updated
Jan 28, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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