Knee Osteoarthritis
Conditions
Brief summary
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
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. 1. Active control - intra-articular 4 milliliters 0.5% bupivacaine + 10mg dexamethasone + sham Pulsed Radiofrequency 2. Placebo control - intra-articular 5 milliliters 0.9% saline + sham Pulsed Radiofrequency 3. 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.
Interventions
PROCEDUREPlacebo Intra-Articular Injection
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.
PROCEDUREPulse Radiofrequency
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.
PROCEDUREStandard of Care Intra- Articular Injection
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.
Sponsors
Center For Interventional Pain and Spine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
test, active, control
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Visual Analogue Scale pain scores | 1-week, 1-, 3-, 6-, and 12-months | Evaluates the level of pain. Minimum=0 Maximum=10, Larger number indicates worse outcome |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change in Patient-Reported Outcomes Measurement Information System-29 and Western Ontario and McMaster Universities Osteoarthritis (Index) | 1-week, 1-, 3-, 6-, and 12-months | 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 |
| Change in Analgesic use | 1-week, 1-, 3-, 6-, and 12-months | Evaluates number of medications, doses of medications |
| Change in Timed Up and Go Test | 1-week, 1-, 3-, 6-, and 12-months | Evaluates physical mobility |
| Change in Progression to Surgery | 1-week, 1-, 3-, 6-, and 12-months | Evaluates effectiveness of treatment |
Countries
United States
Outcome results
None listed