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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-25

Study Completion Date

2025-01-05

Brief Summary

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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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Detailed Description

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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.

Conditions

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Radiofrequency Alcohol Genicular Nerve Knee Osteoarthritis Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Radiofrequency group

Patients will receive radiofrequency.

Group Type EXPERIMENTAL

Radiofrequency

Intervention Type DEVICE

Patients will receive radiofrequency.

30% alcohol group

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.

Group Type EXPERIMENTAL

Alcohol 30%

Intervention Type 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.

50% alcohol group

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.

Group Type EXPERIMENTAL

Alcohol 50%

Intervention Type 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.

70% alcohol group

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.

Group Type EXPERIMENTAL

Alcohol 70%

Intervention Type 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.

Interventions

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Radiofrequency

Patients will receive radiofrequency.

Intervention Type DEVICE

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.

Intervention Type DRUG

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.

Intervention Type DRUG

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.

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No