Clinical Trial: Validity and Reliability of Diagnostic Findings of SI Joint Blocking

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: VaReFi Validity and Reliability of Diagnostic Findings of SI Joint Blocking

Brief Summary: The purpose of the trial is to confirm the validity and reliability of diagnostic SI joint blocks.

Detailed Summary:

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.


Sponsor: SI-BONE, Inc.

Current Primary Outcome: Numeric Rating Scale [ 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). ]

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?



Original Primary Outcome: Numeric Rating Scale [ Time Frame: Baseline, 30 minutes and 60 minutes post injection (x 3 injections, each 1 week apart), 1 month post 3rd injection visit (7 weeks post 1st injection). ]

Change in SI joint pain from prior to injection to 30 and 60 minutes after injection. Changes compared over 3 injections, where injectate is blinded.

Is response to lidocaine different than response to placebo Is response to lidocaine during second injection similar to that during first injection?



Current Secondary Outcome: 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). [ Time Frame: 7 weeks after 1st block & and 27 weeks after 1st block ]

Look at responses in patients who have been diagnosed with an SI joint condition vs. patients who have no SI joint condition diagnosis.


Original Secondary Outcome: Subgroup analysis by diagnosis at 1 month post 3rd injection. [ Time Frame: 7 weeks after 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.


Information By: SI-BONE, Inc.

Dates:
Date Received: May 30, 2013
Date Started: June 2013
Date Completion: January 2017
Last Updated: March 20, 2015
Last Verified: March 2015