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

NCT ID: NCT01875406

Last Updated: 2017-04-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-06-30

Study Completion Date

2016-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Sacroiliac Injection

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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diagnostic exercises

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.

Group Type EXPERIMENTAL

diagnostic exercises

Intervention Type OTHER

Interventions

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diagnostic exercises

Intervention Type OTHER

Other Intervention Names

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questionnaires pain surveys

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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The Cleveland Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maged Guirguis, MD

Role: PRINCIPAL_INVESTIGATOR

The Cleveland Clinic

Locations

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Cleveland Clinic

Cleveland, Ohio, United States

Site Status

Countries

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United States

Other Identifiers

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13-416

Identifier Type: -

Identifier Source: org_study_id

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