Percutaneous vs Conventional Radiofrequency Applications for the Treatment of Knee Osteoarthritic Pain

NCT06520371 | Completed

• 1 other identifier: 36264PR670/4/24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to compare percutaneous and conventional radiofrequency applications for the treatment of knee osteoarthritic pain.

Conditions

Percutaneous; Conventional; Radiofrequency; Knee Osteoarthritis; Pain

Outcome Measures

Primary Outcomes (1)

• Degree of pain

  Degree of pain will be assessed using visual analog scale (VAS). Each patient will obtain a score between 0 and 10 (Zero means no pain, and ten means the worst pain). VAS will be assessed pre-procedure and post-procedure 2nd, 6th, and 12th week.

  12th week post-procedure

Secondary Outcomes (3)

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

  12th week post-procedure

• Patient satisfaction

  12th week post-procedure

• Incidence of adverse events

  12th week post-procedure

Study Arms (2)

Percutaneous radiofrequency group

EXPERIMENTAL

Patients will receive percutaneous radiofrequency.

Device: Percutaneous radiofrequency

Conventional radiofrequency group

ACTIVE COMPARATOR

Patients will receive conventional radiofrequency.

Device: Conventional radiofrequency

Interventions

Percutaneous radiofrequency DEVICE

For the percutaneous radiofrequency treatment, a medium electrode size will be placed on either side of the knee: one skin electrode on the inside and one on the outside of the knee for 15 minutes.

Percutaneous radiofrequency group

Conventional radiofrequency DEVICE

For the conventional radiofrequency treatment, a 50 Hz sensory stimulation will be performed with a 10 cm, 22 gauge, 10 mm active tip radiofrequency cannula. After receiving the appropriate sensory and motor stimuli, a radiofrequency of 90°C will be applied for 90 s.

Conventional radiofrequency 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:

• Prior knee surgery.
• Allergies to local anesthetics.
• Connective tissue diseases affect the knee.
• Serious neurologic or psychiatric disorders.
• Injection with steroids or hyaluronic acids during the previous 3 months.
• History of septic arthritis.
• Sciatic pain.
• Cardiac pacemaker users.
• Anticoagulant medications.
• Prior electroacupuncture treatment.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Osteoarthritis, Knee; Pain

Interventions

Catheter Ablation

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Radiofrequency Ablation; Radiofrequency Therapy; Therapeutics; Ablation Techniques; Surgical Procedures, Operative

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: December 31, 2024
• Study Completion: December 31, 2024
• 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)