Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections
| Status: | Completed |
|---|---|
| Conditions: | Orthopedic |
| Therapuetic Areas: | Orthopedics / Podiatry |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 2/9/2018 |
| Start Date: | May 2014 |
| End Date: | November 2017 |
Randomized, Controlled, Double-blind, Comparative-effectiveness Study Comparing Fluoroscopically-guided and Landmark-guided Sacroiliac Joint Injections
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.
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.
Inclusion Criteria:
1. Age > 18;
2. Low back pain principally below the L5 vertebra;
3. Three out of 6 positive SI joint provocative maneuvers;
4. Agreed to undergo SI joint injection for diagnostic/ therapeutic purposes;
5. Average pain score > 3/10 over the past week;
6. Pain duration > 6 weeks;
Exclusion Criteria:
1. Previous SI joint injection;
2. Leg pain > back pain or lower leg pain > upper leg pain
3. Active inflammatory spondyloarthropathy (e.g. ankylosing spondylitis);
4. Untreated coagulopathy;
5. Allergy to contrast dye or bupivacaine;
6. Pain > 20 years in duration;
7. Poorly controlled psychiatric (e.g. PTSD) or medical (congestive heart failure)
condition
We found this trial at
4
sites
Click here to add this to my saved trials
1800 Orleans St.
Baltimore, Maryland 21287
Baltimore, Maryland 21287
410-955-5000
Principal Investigator: Steven P Cohen, MD
Phone: 410-955-1818
Johns Hopkins Hospital Patients are the focus of everything we do at The Johns Hopkins...
Click here to add this to my saved trials
Rockville, Maryland 20889
Principal Investigator: Scott R Griffith, MD
Phone: 301-400-2595
Click here to add this to my saved trials
Click here to add this to my saved trials