Sacroiliac Joint Pain | Fluoroscopically-guided Versus Landmark-guided Sacroiliac Joint Injections
Sacroiliac Joint Pain research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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 > 4/10 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 > 10 years in duration; 7. Poorly controlled psychiatric (e.g. PTSD) or medical (congestive heart failure) condition
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Sacroiliac Joint Pain
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
Procedure:X-ray SI joint steroid injectionInjection of steroid and local anesthetic into the joint cavity using fluoroscopic guidance
Procedure:Landmark-guided SI steroid injectionInjection 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)
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
X-ray guided intra-articular injectionInjection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine into the SI (sacroiliac joint) cavity under fluoroscopic guidance
Landmark-guided SI joint injectionInjection of 40 mg depomethylprednisolone and 2 ml 0.5% bupivacaine at the point of maximal tenderness (3 ml)
Start Date: March 2014
Completed Date: January 2018
Primary Outcome: Average Back Pain at 1 Month Measured Using the Numeric Pain Scale
Secondary Outcome: Outcomes Related to Disability Measured at 1 Month Using the Oswestry Disability Index
Study sponsors, principal investigator, and references
Lead Sponsor: Johns Hopkins University
Collaborator: Uniformed Services University of the Health Sciences
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. Review.