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| Name | Class |
|---|---|
| Uniformed Services University of the Health Sciences | FED |
| Walter Reed National Military Medical Center | FED |
| Milton S. Hershey Medical Center | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| X-ray guided intra-articular injection | Experimental | Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine into the SI (sacroiliac joint) cavity under fluoroscopic guidance |
|
| Landmark-guided SI joint injection | Active Comparator | Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine at the point of maximal tenderness (3 ml) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| X-ray SI joint steroid injection | Procedure | Injection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance |
|
| Measure | Description | Time Frame |
|---|---|---|
| Average Back Pain at 1 Month Measured Using the Numeric Pain Scale | 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. | 1 month from the start of treatment |
| Measure | Description | Time Frame |
|---|---|---|
| Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index | 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. | 1 month after the start of treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Naval Hospital-San Diego | San Diego | California | United States | |||
| Johns Hopkins Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23253394 | Background | Cohen SP, Chen Y, Neufeld NJ. Sacroiliac joint pain: a comprehensive review of epidemiology, diagnosis and treatment. Expert Rev Neurother. 2013 Jan;13(1):99-116. doi: 10.1586/ern.12.148. | |
| 30853260 | Derived | Cohen SP, Bicket MC, Kurihara C, Griffith SR, Fowler IM, Jacobs MB, Liu R, Anderson White M, Verdun AJ, Hari SB, Fisher RL, Pasquina PF, Vorobeychik Y. Fluoroscopically Guided vs Landmark-Guided Sacroiliac Joint Injections: A Randomized Controlled Study. Mayo Clin Proc. 2019 Apr;94(4):628-642. doi: 10.1016/j.mayocp.2018.08.038. Epub 2019 Mar 8. |
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| ID | Term |
|---|---|
| D017116 | Low Back Pain |
| ID | Term |
|---|---|
| D001416 | Back Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| United States Naval Medical Center, San Diego |
| FED |
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| Landmark-guided SI steroid injection | Procedure | 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) |
|
| Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale |
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. |
| 1 month from the start of treatment |
| Average Back Pain at 3 Months Measured Using the Numeric Pain Scale | 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. | 3 months from the start of treatment |
| Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale | 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. | 3 months after the start of treatment |
| Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index | 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. | 3 months after the start of treatment |
| Patient satisfaction of the procedure at 1 month measured using the Likert Scale | 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. | 1 month |
| Patient satisfaction of the procedure at 3 months measured using the Likert Scale | 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. | 3 months |
| Positive categorical outcome | 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 | 1 month |
| Positive categorical outcome | Decrease in average back pain score at 3 months of greater or equal to 2 points coupled with a satisfaction score > 3 on a 1-5 scale | 3 months |
| Positive diagnostic blocks | The percentage of participants who experience greater or equal to 50% pain relief based on their pain diary | 6 hours |
| Baltimore |
| Maryland |
| 21205 |
| United States |
| Walter Reed National Military Medical Center | Rockville | Maryland | 20889 | United States |
| Penn State | Hershey | Pennsylvania | 17033 | United States |
| D013568 |
| Pathological Conditions, Signs and Symptoms |