Sacroiliac Joint Pain
Conditions
Keywords
sacroiliac joint, low back pain, steroid injection
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.
Interventions
PROCEDUREX-ray SI joint steroid injection
Injection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance
PROCEDURELandmark-guided SI steroid injection
Injection of steroid into the joint area based on palpation. The injection may be inside the joint (intra-articular) or outside the joint in the ligaments (extra-articular)
Sponsors
Uniformed Services University of the Health Sciences
Walter Reed National Military Medical Center
Milton S. Hershey Medical Center
United States Naval Medical Center, San Diego
Johns Hopkins University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Average Back Pain at 1 Month Measured Using the Numeric Pain Scale | 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
| Measure | Time frame | Description |
|---|---|---|
| Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale | 1 month from the start of treatment | This outcome measure compares the worst back pain at baseline to the worst back pain at 1 months 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. |
| Average Back Pain at 3 Months Measured Using the Numeric Pain Scale | 3 months from the start of treatment | This outcome measure compares the average back pain at baseline to the average back pain at 3 months 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. |
| Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale | 3 months after the start of treatment | This outcome measure compares the worst back pain at baseline to the worst back pain at 3 months 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. |
| Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index | 3 months after the start of treatment | Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible. |
| Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index | 1 month after the start of treatment | Functional capacity measured using Oswestry disability index. The range of possible scores for Oswestry Disability Index are 0-100. 0 is equated with no disability and 100 is the maximum disability possible. |
| Patient satisfaction of the procedure at 3 months measured using the Likert Scale | 3 months | Patient satisfaction is measured at 1 month after the procedure using the Likert Scale. The range of possible scores for the Likert Scale are 1-5. I being very unsatisfied and 5 being very satisfied. |
| Positive categorical outcome | 1 month | Decrease in average back pain score at 1 month of greater or equal to 2 points coupled with a satisfaction score \> 3 on a 1-5 scale |
| Positive diagnostic blocks | 6 hours | The percentage of participants who experience greater or equal to 50% pain relief based on their pain diary |
| Patient satisfaction of the procedure at 1 month measured using the Likert Scale | 1 month | Patient satisfaction is measured at 1 month after the procedure using the Likert Scale. The range of possible scores for the Likert Scale are 1-5. I being very unsatisfied and 5 being very satisfied. |
Countries
United States
Outcome results
None listed