Clinical trial NCT02096653: Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections
Official title: Randomized, Controlled, Double-blind, Comparative-effectiveness Study Comparing Fluoroscopically-guided and Landmark-guided Sacroiliac Joint Injections
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sacroiliac Joint Pain
Keywords: sacroiliac joint
low back pain
steroid injection
Lead sponsor: Johns Hopkins University
Sponsor class: OTHER
Collaborators: name: Uniformed Services University of the Health Sciences
name: Walter Reed National Military Medical Center
name: Milton S. Hershey Medical Center
name: United States Naval Medical Center, San Diego
First posted: 2014-03-26
Enrollment: 125
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Average Back Pain at 1 Month Measured Using the Numeric Pain Scale
timeFrame: 1 month from the start of treatment
Secondary outcomes:
measure: Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index
timeFrame: 1 month after the start of treatment
measure: Worst Back Pain at 1 Month Measured Using the Numeric Pain Scale
timeFrame: 1 month from the start of treatment
measure: Average Back Pain at 3 Months Measured Using the Numeric Pain Scale
timeFrame: 3 months from the start of treatment
measure: Worst Back Pain at 3 Months Measured Using the Numeric Pain Scale
timeFrame: 3 months after the start of treatment
measure: Outcomes Related to Disability Measured at 3 Month Using the Oswestry Disability Index
timeFrame: 3 months after the start of treatment
measure: Patient satisfaction of the procedure at 1 month measured using the Likert Scale
timeFrame: 1 month
measure: Patient satisfaction of the procedure at 3 months measured using the Likert Scale
timeFrame: 3 months
measure: Positive categorical outcome
timeFrame: 1 month
measure: Positive categorical outcome
timeFrame: 3 months
measure: Positive diagnostic blocks
timeFrame: 6 hours
Other outcomes:
Locations:
city: San Diego
country: United States
facility: Naval Hospital-San Diego
state: California
city: Baltimore
country: United States
facility: Johns Hopkins Hospital
state: Maryland
city: Rockville
country: United States
facility: Walter Reed National Military Medical Center
state: Maryland
city: Hershey
country: United States
facility: Penn State
state: Pennsylvania
Study officials:
References:
citation: 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.
citation: 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.