Unipolar Versus Bipolar Radiofrequency Ablation in Knee Osteoarthritis Pain

Tanta University64 enrolled

Overview

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).

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Enrollment

Conditions

Bipolar Radiofrequency Ablation Unipolar Radiofrequency Ablation Knee Osteoarthritis Pain

Interventions

Unipolar radiofrequency ablationPROCEDURE

Patients will undergo radiofrequency ablation (RFA) of three genicular nerves (superior medial, superior lateral and inferior medial) with one cannula.

Bipolar radiofrequency ablationPROCEDURE

Patients will undergo radiofrequency ablation (RFA) as unipolar RFA but with two cannulas.

Eligibility

Sex: ALLMin age: 50 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Age \> 50 years. * Both genders. * Diagnosed with chronic knee osteoarthritis (KOA) according to the American College of Rheumatology (ACR) criteria and confirmed with plain radiography as the gold standard for the diagnosis of KOA. * One chronic KOA pain not responding to other treatments as physiotherapy, oral analgesics, and intraarticular injection with hyaluronic acids or steroids. * Kellgren-Lawrence grade (II-IV). Exclusion Criteria: * Chronic knee pain induced by infection, inflammation, tumors, and fractures. * Prior knee surgery. * Acute knee pain. * Connective tissue diseases. * Neurologic or psychiatric disorders. * Intra-articular knee corticosteroid or hyaluronic acids in the past 3 months. * Anticoagulant medication. * Local infection of the site of intervention. * Cognitive impairment.

Locations (1)

Tanta University

Tanta, El-Gharbia, Egypt

RECRUITING

Outcomes

Primary Outcomes

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

Secondary Outcomes

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

Central Contacts

Mohammed S Elsharkawy, MD

CONTACT

00201148207870 mselsharkawy@med.tanta.edu.eg

Data from ClinicalTrials.gov

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