Overview

This trial is active, not recruiting.

Condition sacroiliac injection
Treatment diagnostic exercises
Sponsor The Cleveland Clinic
Start date June 2013
End date December 2015
Trial size 200 participants
Trial identifier NCT01875406, 13-416

Summary

The purpose of this study is to determine the predictive value of a composite of 3 simple, clinically practical, diagnostic tests (Mekhail, Patrick's and Thigh thrust) combined with a pain referral diagram in predicting response to a single diagnostic SIJ injection. The goal is to test these 3 tests and compare their predictive value to the 6 tests commonly reported in the literature in order to provide a clinician with clinically practical special tests to aide in the diagnosis and treatment of SIJ mediated pain. Specifically, the investigators seek to evaluate the prognostic capacity for a series of three clinical tests (Mekhail's Test, thigh thrust and Patrick's Test) combined with a pain referral diagram to accurately predict the response (change in VAS) of a single diagnostic Sacroiliac joint and extra-capsular joint injection.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose supportive care
Arm
(Experimental)
The three diagnostic exercises will be administered in random order to minimize effects of order and period on the results. Enrollment logs and study randomization will be administered electronically via a respective REDCap data modules. The enrollment, randomization and diagnostic tests will be administered by research coordinator or PI. The patients will be independently evaluated and scheduled for SIJ injection by Cleveland Clinic pain clinic staff and fellow pain physicians.
diagnostic exercises questionnaires

Primary Outcomes

Measure
validity of assessments
time frame: Day 1

Secondary Outcomes

Measure
prognostic assessment
time frame: Day 1

Eligibility Criteria

Male or female participants from 18 years up to 90 years old.

Inclusion Criteria: - any patient presenting with low back pain with or without radicular symptoms, regardless of prior history of back surgery from 18-90 years old whom after being evaluated by an independent clinician in the Cleveland Clinic pain clinic has been scheduled for a diagnostic SIJ injection. Exclusion Criteria: - any patient less than 18 or greater than 90 years old, has any medical condition that would not allow them to complete the study, diagnosis of any recent fractures in the lumbar spine, recent infection, pregnancy, taking anticoagulants.

Additional Information

Official title Diagnosis of Sacroiliac Joint Pain: Predictive Value of a Diagnostic SIJ Injection Following a Composite of 3 Diagnostic Tests and a Pain Referral Diagram
Principal investigator Maged Guirguis, MD
Trial information was received from ClinicalTrials.gov and was last updated in July 2015.
Information provided to ClinicalTrials.gov by The Cleveland Clinic.