The purpose of the trial is to confirm the validity and reliability of diagnostic SI joint blocks.
Subjects with suspected SI joint pain will undergo 3 SI joint blocks, 2 with local anesthetic and 1 sham block. The sequence of blocks is randomly assigned. This study examines both the test-retest reliability of response to diagnostic sacroiliac (SI) joint injection and the specificity of response to local anesthetic or sham block. The goal of the study is to validate the use of diagnostic SI joint block. Subjects with pain suspected to be generated by one SI joint will undergo three diagnostic SI joint blocks each separated by one week. Two blocks will be with local anesthetic (LA) and one will be a sham block (SB). Both the Coordinator (collecting pain assessments) and subject will be blinded to the sequence of blocks (LA or SB each time). The sequence of blocks will be randomly assigned for each subject on study. The subject's participation in the study is complete after 6-month post-procedure assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
DOUBLE
Enrollment
28
Week 1: SI joint injection with .75% bupivacaine Week 2: SI joint injection with .75% bupivacaine Week 3: SI joint sham block
Week 1: SI join sham block Week 2: SI joint injection with .75% bupivacaine Week 3: SI joint injection with .75% bupivacaine
Week 1: SI join injection with .75% bupivacaine Week 2: SI join sham block Week 3: SI joint injection with .75% bupivacaine
Orthopedic Center of Southern Illinois
Mount Vernon, Illinois, United States
Bluegrass Orthopaedics and Hand Care Research, LLC
Lexington, Kentucky, United States
Cleveland Clinic
Cleveland, Ohio, United States
Penn State College Of Medicine
Hershey, Pennsylvania, United States
Numeric Rating Scale
Change in SI joint pain from prior to injection to 30 minutes, 60 minutes, 2 hours, 4 hours after injection. Changes compared over 3 injections, where type of block is blinded. Is response to bupivacaine different than response to sham block Is response to bupivacaine during second injection similar to that during first injection?
Time frame: Baseline, 30 minutes and 60 minutes, 2 and 4 hours post injection (x 3 injections, each 1 week apart), and 1 month post 3rd injection visit (7 weeks post 1st injection).
Subgroup analysis by diagnosis at 1 month post 3rd block (7 weeks post 1st injection) and 6 month post 3rd injection visit ( 27 weeks post 1st injection).
Look at responses in patients who have been diagnosed with an SI joint condition vs. patients who have no SI joint condition diagnosis.
Time frame: 7 weeks after 1st block & and 27 weeks after 1st block
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Precision Spine Care
Tyler, Texas, United States
Physicians' Research Options, LLC
Sandy City, Utah, United States
Virginia iSpine Research Institute, Inc
Richmond, Virginia, United States