A Placebo-Controlled Study Assessing Lateral Branch Radiofrequency Denervation for Sacroiliac (SI) Joint Pain
- Conditions
- Low Back Pain
- Registration Number
- NCT00373724
- Lead Sponsor
- Johns Hopkins University
- Brief Summary
In order to determine whether L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation is effective for sacroiliac (SI) joint pain, we are conducting a randomized, controlled study.
- Detailed Description
30 subjects with SI joint pain confirmed by SI joint injections will be randomized to receive either L4 and L5 primary dorsal rami and S1-3 lateral branch radiofrequency denervation or sham denervation. To facilitate patient blinding, in both groups 1 ml of lidocaine will be injected before true (or sham) denervation so patients cannot feel heating. The stimulation will be the same for both groups and blinding assessed after the procedure. Follow-up visits will be at 1,3 and 6-months postprocedure.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 30
- Sacroiliac joint pain
- Age > 18
- No focal neurological signs or symptoms, coagulopathy, unstable medical or psychiatric condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Primary Outcome Measures
Name Time Method visual analogue scale pain score, Oswestry Disability Index 1, 3 and 6 months postprocedure
- Secondary Outcome Measures
Name Time Method Medication reduction, global perceived effect, work status
Trial Locations
- Locations (2)
Walter Reed Army Medical Center
🇺🇸Washington, District of Columbia, United States
Johns Hopkins School of Medicine
🇺🇸Baltimore, Maryland, United States