Bipolar Radiofrequency Ablation, Knee Osteoarthritis, Pain, Unipolar Radiofrequency Ablation
Conditions
Brief summary
This study aims to compare the efficacy of unipolar versus bipolar radiofrequency ablation (RFA) in knee osteoarthritis pain.
Detailed description
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).
Interventions
PROCEDUREUnipolar radiofrequency ablation
Patients will undergo radiofrequency ablation (RFA) of three genicular nerves (superior medial, superior lateral and inferior medial) with one cannula.
PROCEDUREBipolar radiofrequency ablation
Patients will undergo radiofrequency ablation (RFA) as unipolar RFA but with two cannulas.
Sponsors
Tanta University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of successful responders with a reduction 50% of pain | 24 weeks after the procedure | The proportion of successful responders with a reduction 50% of Visual Analog Scale (VAS) will be recorded. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Degree of pain | 24 weeks after the procedure | 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. |
| Oxford Knee Score (OKS) | 24 weeks after the procedure | 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. |
Countries
Egypt
Contacts
CONTACTMohammed S Elsharkawy, MD
Outcome results
None listed