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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.
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Active | Active Comparator | intra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency |
|
| Control | Placebo Comparator | intra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency |
|
| Experimental | Experimental | intra-articular 5 milliliters 0.5% bupivacaine + Pulsed Radiofrequency |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pulse Radiofrequency | Procedure | 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. |
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael A Fishman, MD | Center For Interventional Pain and Spine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Interventional Pain and Spine | Exton | Pennsylvania | 19341 | United States |
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test, active, control
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|
| Standard of Care Intra- Articular Injection | Procedure | 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. |
|
| Placebo Intra-Articular Injection | Procedure | 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. |
|
| 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 |
| ID | Term |
|---|---|
| D020370 | Osteoarthritis, Knee |
| ID | Term |
|---|---|
| D010003 | Osteoarthritis |
| D001168 | Arthritis |
| D007592 | Joint Diseases |
| D009140 | Musculoskeletal Diseases |
| D012216 | Rheumatic Diseases |
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