Intra-articular Pulsed Radiofrequency Neuromodulation Versus Intra-articular Steroids for Painful Knee Osteoarthritis

Study Overview
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Brief Summary
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To compare the efficacy of intra-articular pulsed radiofrequency to intra-articular steroids in patients with moderate-severe painful osteoarthritis of the knee.

Detailed Description
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Patients Adult patients with intractable knee pain for more than 6 months and radiographic evidence of grade II, III or IV knee osteoarthritis. Must not have had a knee injection or other interventional procedure for knee pain within the past 12 weeks. Must be on stable medications for the past 12 weeks and willing to keep medications stable for the first 12 weeks of the study. Study Design Pilot study will enroll 30 patients randomized 1:1:1. Active control - intra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency Placebo control - intra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency Treatment group - intra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency Methods Two 18-gauge radiofrequency needle with 10 millimeter active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Pulsed Radiofrequency or sham-Pulsed Radiofrequency treatment will be administered. Subsequently, the injectate will be administered. Dexamethasone is selected as the corticosteroid as it is colorless and will be indistinguishable from the saline used in the Intra-articular Pulsed Radiofrequency and placebo groups.

Official Title
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Sham-controlled Randomized Trial of Intra-articular Pulsed Radiofrequency Neuromodulation Versus Intra-articular Steroids for Painful Knee Osteoarthritis

Conditions
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Knee Osteoarthritis

Intervention / Treatment
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* Procedure: Pulse Radiofrequency
* Procedure: Standard of Care Intra- Articular Injection
* Procedure: Placebo Intra-Articular Injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capable of giving written informed consent Patients aged 18 years or older Patients with unilateral or bilateral knee pain for at least 3 months Radiographic evidence of knee osteoarthritis Appropriate candidate for steroid injection as determined by the investigator Exclusion Criteria: Chronic knee pain caused by infection, inflammation, tumors, and fractures A history of acute knee pain, previous knee surgery, connective tissue diseases, progressive neurologic disease or uncontrolled psychiatric disorders The administration of steroids or hyaluronic acids within the last three months Coagulation disorders Local infection at the site of intervention planned Active litigation related to this pain complaint

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: test, active, control
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Active<br>intra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency | Procedure: Placebo Intra-Articular Injection<br>* Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Placebo Intra-Articular treatment will be administered.<br>|
| Placebo Comparator: Control<br>intra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency | Procedure: Standard of Care Intra- Articular Injection<br>* Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Intra-Articular treatment will be administered.<br>|
| Experimental: Experimental<br>intra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency | Procedure: Pulse Radiofrequency<br>* Two 20-gauge radiofrequency needle with 10mm active tip will be placed intra-articularly from an anterolateral and anteromedial approach to target the medial and lateral compartments. Once satisfactory fluoroscopic placement is noted, the Pulsed Radiofrequency treatment will be administered.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Visual Analogue Scale pain scores | Evaluates the level of pain. Minimum=0 Maximum=10, Larger number indicates worse outcome | 1-week, 1-, 3-, 6-, and 12-months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Patient-Reported Outcomes Measurement Information System-29 and Western Ontario and McMaster Universities Osteoarthritis (Index) | Evaluates level of pain. For Patient-Reported Outcomes Measurement Information System-29, Minimum= 8 and Maximum=40. For Western Ontario and McMaster Universities Osteoarthritis (Index), Minimum=0 Maximum=20. Larger number indicates worse outcome | 1-week, 1-, 3-, 6-, and 12-months | 
| Change in Analgesic use | Evaluates number of medications, doses of medications | 1-week, 1-, 3-, 6-, and 12-months | 
| Change in Timed Up and Go Test | Evaluates physical mobility | 1-week, 1-, 3-, 6-, and 12-months | 
| Change in Progression to Surgery | Evaluates effectiveness of treatment | 1-week, 1-, 3-, 6-, and 12-months |