CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 55 enrolled
Drug / intervention
SIJ pain diagnostic testsother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02950129
NCT02950129Phase 2Completed

IRB-HSR # 14073 Investigation of Pelvic Girdle Dysfunction in the Low Back Pain Population

University of Virginia·interventional·Posted Oct 31, 2016·Updated Oct 31, 2016

In Brief

A Phase 2 clinical trial evaluating SIJ pain diagnostic tests for Back Pain. Completed, enrolled 55 participants across 1 site.

Detailed Summary

The subjects will undergo a specific physical exam of tests reported to be diagnostic of sacroiliac joint (SIJ) pain prior to receiving the routine injection in the SIJ that which is being performed as part of their normal medical care. Routine care involves use of any number of these tests, but doesn't routinely include assessment of all 6 tests in all patient's treatment. The subject will fill out a Visual Analog Scale for pain and a pain drawing prior to and after the injection. The tests will be repeated after the injection. The investigators propose to investigate a cluster of tests proposed by Laslett as well as compare the results of the ASLR and the Gillet Test both before and after SIJ injection to determine the validity of these tests in a low back patients presenting for injections thought to be from the sacroiliac joint. The secondary purpose would be the development of a clinical predictor rule to determine examination characteristics of patients who may benefit from intraarticular injections of the SIJ.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBack Pain
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedOct 31, 2016
Enrollment StartFeb 1, 2009
Primary CompletionJun 1, 2011
TodayJul 2, 2026
Enrollment to primary: 2.3 yearsPosted 9.7 years ago

Interventions

SIJ pain diagnostic testsother

The subjects will undergo a specific physical exam of tests reported to be diagnostic of sacroiliac joint (SIJ) pain prior to receiving the routine injection in the SIJ; all tests will be repeated after the SIJ injection