Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration

Study Overview
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Brief Summary
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A single blinded randomized controlled trial to compare outcomes of patients with chronic knee pain receiving radiofrequency with or without corticosteroids.

Official Title
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A Single Blinded Randomized Controlled Clinical Trial Comparing Outcome Measures of Pulsed Radiofrequency of the Genicular Nerves When Performed With and Without Concomitant Local Corticosteroid Administration

Conditions
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Knee Pain Chronic

Intervention / Treatment
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* Device: pulsed radiofrequency modulation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Men and women with pain secondary to osteoarthritis of the knee Age of 18 years and up Fits criteria for procedure of genicular nerve block and pulsed radiofrequency neuromodulation Exclusion Criteria: Patients who are incapable of judgment and/or to give informed consent Patients who are pregnant Patients who are under 18 years old Patients who have allergies to local anesthetic Patients with platelet dysfunction or bleeding disorders Patients who are currently mentally unstable Patients who have a diagnosis of fibromyalgia

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: radiofrequency with corticosteroids<br>corticosteroids- 80mg depo-medrol Pulsed radiofrequency to 42 derees celsius for 6 minutes | Device: pulsed radiofrequency modulation<br>* a percutaneous needle electrode to apply pulsed RF signals that modulate the activity of sensory nerves. The pulsing of the RF signal permits a maximum temperature to be achieved - usually 42 Celsius. This helps prevent collateral damage from occurring during the procedure and should help reduce procedural complications.<br>|
| Active Comparator: radiofrequency without corticosteroids<br>Pulsed radiofrequency to 42 derees celsius for 6 minutes | Device: pulsed radiofrequency modulation<br>* a percutaneous needle electrode to apply pulsed RF signals that modulate the activity of sensory nerves. The pulsing of the RF signal permits a maximum temperature to be achieved - usually 42 Celsius. This helps prevent collateral damage from occurring during the procedure and should help reduce procedural complications.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Improvement in chronic knee pain | Measured by the Knee injury and Osteoarthritis Outcome Score; higher scores indicating that the patients experiences more impairment (All items are scored 0-4; for each subscale the scores are transformed to a 0-100 scale; 0 representing extreme knee problems and 100 representing no knee problems). | 2nd and 6th week |