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

NCT06520384 | Completed

• 1 other identifier: 36264PR671/4/24
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiofrequency; Alcohol; Genicular Nerve; Knee Osteoarthritis; Pain

Outcome Measures

Primary Outcomes (1)

• Degree of knee pain

  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

  6 months postoperative

Secondary Outcomes (3)

• Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores

  6 months postoperative

• Patient satisfaction

  6 months postoperative

• Incidence of adverse events

  6 months postoperative

Study Arms (4)

Radiofrequency group

EXPERIMENTAL

Patients will receive radiofrequency.

Device: Radiofrequency

30% alcohol group

EXPERIMENTAL

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.

Drug: Alcohol 30%

50% alcohol group

EXPERIMENTAL

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.

Drug: Alcohol 50%

70% alcohol group

EXPERIMENTAL

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.

Drug: Alcohol 70%

Interventions

Radiofrequency DEVICE

Patients will receive radiofrequency.

Radiofrequency group

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.

30% alcohol group

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.

50% alcohol group

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.

70% alcohol group

Eligibility Criteria

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

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: July 21, 2024
• First Posted: July 25, 2024
• Study Start: July 25, 2024
• Primary Completion: January 5, 2025
• Study Completion: January 5, 2025
• Last Updated: January 28, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)