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

January 27, 2025 updated by: Mohammed Said ElSharkawy, Tanta University

Comparison of Percutaneous and Conventional Radiofrequency Applications for the Treatment of Knee Osteoarthritic Pain: A Randomized Controlled Trial

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Osteoarthritis (OA) is a progressive degenerative joint disease that affects the joint cartilage and surrounding tissues. It mostly affects the weight-bearing joints, and in this respect, the knee joint is one of the joints that is most affected.

Radiofrequency (RF) treatment has been used for several painful conditions such as trigeminal neuralgia, cancer pain, and spinal pain. To destroy nerves or disrupt the transmission of pain signals, originally using producing heat lesions, RF current is applied to the trigeminal ganglion, the spinothalamic tracts of the spinal cord, the medial branches of posterior rami, and the dorsal root ganglion. In addition to these, there have been a few attempts to apply RF current for the treatment of painful conditions of joints of the extremities.

Percutaneous radiofrequency ablation (RFA) of articular sensory nerves has recently emerged as an attractive and minimally invasive approach to treat chronic pain due to large-joint osteoarthritis in select patients.

Study Type

Interventional

Enrollment (Actual)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
    • El-Gharbia
      • Tanta, El-Gharbia, Egypt, 31527
        • Tanta University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Percutaneous radiofrequency group
Patients will receive percutaneous radiofrequency.
Device: Percutaneous radiofrequency
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.
Active Comparator: Conventional radiofrequency group
Patients will receive conventional radiofrequency.
Device: Conventional radiofrequency
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Degree of pain
Time Frame: 12th week post-procedure
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores
Time Frame: 12th week post-procedure
Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) scores: 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 pre-procedure and post-procedure 1, 4, and 12th week.
12th week post-procedure
Patient satisfaction
Time Frame: 12th week post-procedure
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). It will be assessed pre-procedure and post-procedure 1, 4, and 12th week.
12th week post-procedure
Incidence of adverse events
Time Frame: 12th week post-procedure
Incidence of adverse events such as bleeding, neurological damage, infection, abnormal proprioception, numbness, paresthesia, and motor weakness will be recorded.
12th week post-procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 25, 2024

Primary Completion (Actual)

December 31, 2024

Study Completion (Actual)

December 31, 2024

Study Registration Dates

First Submitted

July 21, 2024

First Submitted That Met QC Criteria

July 21, 2024

First Posted (Actual)

July 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

January 27, 2025

Last Verified

January 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 36264PR670/4/24

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The data will be available upon a reasonable request from the corresponding author after the end of study for one year.

IPD Sharing Time Frame

After the end of study for one year.

IPD Sharing Access Criteria

The data will be available upon a reasonable request from the corresponding author.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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