a Diagnostic SIJ Injection Following a Composite of 3 Diagnostic Tests and a Pain Referral Diagram

NeuroTherapia, Inc.

Status: Completed

Conditions: Sacroiliac Injection

Treatments: Other: diagnostic exercises

Study type: Interventional

Funder types: Other

Identifiers

NCT01875406

13-416

Details and patient eligibility

About

The purpose of this study is to determine the predictive value of a composite of 3 simple clinically practical diagnostic tests (Mekhail's test, Patrick's and Thigh thrust) combined with a pain referral diagram in predicting response to a single diagnostic SIJ injection.

Full description

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, we 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.

Enrollment: 200 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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200 participants in 1 patient group

diagnostic exercises

Experimental group

Description:

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.

Treatment:

Other: diagnostic exercises