Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections

Not Applicable

Completed

• Conditions: Sacroiliac Joint Pain
• Interventions: Procedure: Landmark-guided SI steroid injection; Procedure: X-ray SI joint steroid injection

• Registration Number: NCT02096653
• Lead Sponsor: Johns Hopkins University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-03-22
• Study First Submitted QC: 2014-03-25
• Study First Posted: 2014-03-26
• Study Start: 2014-05
• Primary Completion: 2017-11
• Study Completion: 2017-11
• Status Verified: 2018-02
• Last Update Submitted: 2018-02-05
• Last Update Posted: 2018-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Landmark-guided SI joint injection	Landmark-guided SI steroid injection	Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine at the point of maximal tenderness (3 ml)
X-ray guided intra-articular injection	X-ray SI joint steroid injection	Injection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine into the SI (sacroiliac joint) cavity under fluoroscopic guidance

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.
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.
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.
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	3 months	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
Positive diagnostic blocks	6 hours	The percentage of participants who experience greater or equal to 50% pain relief based on their pain diary

Trial Locations

Locations (4)

Penn State; 🇺🇸 Hershey, Pennsylvania, United States

Naval Hospital-San Diego; 🇺🇸 San Diego, California, United States

Walter Reed National Military Medical Center; 🇺🇸 Rockville, Maryland, United States

Johns Hopkins Hospital; 🇺🇸 Baltimore, Maryland, United States