Randomized, Controlled, Double-blind, Comparative-effectiveness Study Comparing Fluoroscopically-guided and Landmark-guided Sacroiliac Joint Injections
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Sacroiliac Joint Pain
- Sponsor
- Johns Hopkins University
- Enrollment
- 125
- Locations
- 4
- Primary Endpoint
- Average Back Pain at 1 Month Measured Using the Numeric Pain Scale
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
In this study, the investigators are attempting to determine whether intra- or extra-articular injections are more effective; the relative prevalence rate of intra-articular and extra-articular SI joint pain; and the accuracy of extra-articular injections using fluoroscopy as the reference standard. 124 consecutive patients with mechanical low back pain below L5, tenderness overlying the SI joint(s) and at least 3 positive provocative maneuvers will be randomized to receive SI joint injections by 2 different approaches.
Group 1 will receive fluoroscopically-guided injections into the joint. Group 2 will receive landmark-guided injections into the tender area around the joint. In order to determine whether the injection in group 2 was intra-articular or extra-articular, an x-ray will be done after the injection to ascertain the location of contrast spread. The primary outcome measure will be pain relief at 1-month. Patients who obtain benefit at 1-month will be followed at 3-months, while those who fail to obtain benefit will exit the study to receive alternative care.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Low back pain principally below the L5 vertebra;
- •Three out of 6 positive SI joint provocative maneuvers;
- •Agreed to undergo SI joint injection for diagnostic/ therapeutic purposes;
- •Average pain score \> 3/10 over the past week;
- •Pain duration \> 6 weeks;
Exclusion Criteria
- •Previous SI joint injection;
- •Leg pain \> back pain or lower leg pain \> upper leg pain
- •Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);
- •Untreated coagulopathy;
- •Allergy to contrast dye or bupivacaine;
- •Pain \> 20 years in duration;
- •Poorly controlled psychiatric (e.g. PTSD) or medical (congestive heart failure) condition
Outcomes
Primary Outcomes
Average Back Pain at 1 Month Measured Using the Numeric Pain Scale
Time Frame: 1 month from the start of treatment
This outcome measure compares the average back pain at baseline to the average back pain 1 month after the start of treatment. This is measured using the Numeric Pain Scale. The Numeric Pain Scale ranges from 0-10. 0 being no pain at all and 10 being the worst imaginable pain possible. The group receiving fluoroscopically-guided intra-articular injection is compared to the group receiving landmark-guided injections.
Secondary Outcomes
- Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index(1 month after the start of treatment)
- Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale(1 month from the start of treatment)
- Average Back Pain at 3 Months Measured Using the Numeric Pain Scale(3 months from the start of treatment)
- Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale(3 months after the start of treatment)
- Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index(3 months after the start of treatment)
- Patient satisfaction of the procedure at 1 month measured using the Likert Scale(1 month)
- Patient satisfaction of the procedure at 3 months measured using the Likert Scale(3 months)
- Positive categorical outcome(3 months)
- Positive diagnostic blocks(6 hours)