An interventional study of Unipolar radiofrequency ablation and Bipolar radiofrequency ablation in Bipolar Radiofrequency Ablation, Unipolar Radiofrequency Ablation and Knee Osteoarthritis, sponsored by Tanta University. Recruiting at 1 site in Egypt. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2026-09-01.
Sponsored by Tanta University · Not applicable, Interventional, and Treatment
This study aims to compare the efficacy of unipolar versus bipolar radiofrequency ablation (RFA) in knee osteoarthritis pain.
Osteoarthritis (OA) is one of the most common underlying causes of chronic knee pain resulting in loss of ability. Chronic knee pain due to OA is a debilitating disease. Many therapeutic options have been used to manage this pain such as physical therapy, non-steroid anti-inflammatory drugs (NSAIDs), tramadol, opioids, intraarticular hyaluronic acid, and steroids.
Radiofrequency ablation (RFA) appears to be effective for treatment of knee pain. It acts by interrupting the pain conduction through production of a thermal lesion to interrupt nociceptive signals.
A diagnostic genicular nerve block with local anesthetic is performed before genicular nerve RFA, and a positive result indicates the need for genicular RFA In conventional monopolar RFA (MRFA) technique, the localization of genicular nerves is one through sensory stimulation at the junction of epicondyle with the shaft of femur bone (near periosteum).
Exclusion Criteria:
Patients will undergo radiofrequency ablation (RFA) of three genicular nerves (superior medial, superior lateral and inferior medial) with one cannula.
Procedure: Unipolar radiofrequency ablation
Patients will undergo radiofrequency ablation (RFA) as unipolar RFA but with two cannulas.
Procedure: Bipolar radiofrequency ablation
Patients will undergo radiofrequency ablation (RFA) of three genicular nerves (superior medial, superior lateral and inferior medial) with one cannula.
Patients will undergo radiofrequency ablation (RFA) as unipolar RFA but with two cannulas.
Proportion of successful responders with a reduction 50% of pain
The proportion of successful responders with a reduction 50% of Visual Analog Scale (VAS) will be recorded.
Time frame: 24 weeks after the procedure
Degree of pain
Knee pain will be measured by visual Analog Scale (VAS) (0 - no pain to 10-worst imaginable pain) at baseline, 1, 4, 12 and 24 weeks after the procedure during movement.
Time frame: 24 weeks after the procedure
Oxford Knee Score (OKS)
The functional changes in the knee will be assessed by Oxford Knee Score (OKS). It is simple, valid, self-administered, joint-specific 12-item questionnaires ranging from 12 to 60, with 12 referred to the best result.
Time frame: 24 weeks after the procedure
Plan to share: Yes — The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
Supporting information: Study protocol
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