Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections

Study Overview
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Brief Summary
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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.

Official Title
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Randomized, Controlled, Double-blind, Comparative-effectiveness Study Comparing Fluoroscopically-guided and Landmark-guided Sacroiliac Joint Injections

Conditions
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Sacroiliac Joint Pain

Intervention / Treatment
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* Procedure: X-ray SI joint steroid injection
* Procedure: Landmark-guided SI steroid injection


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18; 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 100 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: X-ray guided intra-articular injection<br>Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine into the SI (sacroiliac joint) cavity under fluoroscopic guidance | Procedure: X-ray SI joint steroid injection<br>* Injection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance<br>|
| Active Comparator: Landmark-guided SI joint injection<br>Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine at the point of maximal tenderness (3 ml) | Procedure: Landmark-guided SI steroid injection<br>* 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)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sacroiliac joint, low back pain, steroid injection