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

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 Overview

• Status: Completed
• Conditions: Back Pain
• Intervention / Treatment: Other: SIJ pain diagnostic tests

Detailed Description

Low back pain has been the subject of extensive research in the past 10 years. Some of the efforts have focused on the effectiveness of diagnostic testing in determining the etiology of low back pain. One component of low back pain clinically can be sacroiliac joint (SIJ) dysfunction. The prevalence of sacroiliac pain in the low back pain population is reported to be approximately 10 to 30%. The diagnosis of sacroiliac pain has been an area of controversy in the literature with poor inter-tester and intra-rater reliability described for motion testing. More recently, a cluster of provocation tests has been described as predictive of the diagnosis of sacroiliac dysfunction. Laslett et al suggested that SI pain provocation tests used in examination should include a cluster of six tests. When three or more out of six tests or any two of four selected tests are positive, that showed the best predictive power in diagnosing SIJ pain. The "gold standard" for diagnosing SIJ pain in this study was pain relief with intra-articular local anesthetic block injection. When all six provocation tests do not provoke the patient's typical pain, the SIJ can be ruled out as a source of current low back pain.

Pelvic girdle pain including SIJ dysfunction has been investigated in post partum populations. The Active Straight Leg Raise (ASLR) has been shown to be reliable in post partum pelvic pain. This test is thought to help assess hypermobility in the SIJ. This test has a positive likelihood ratio (+LR)= 14.5 and a negative likelihood ratio (-LR)= .14 which indicates that this is a good test to rule in or rule out pelvic girdle pain in pregnancy. This test is thought to help assess dysfunction of the SIJ. The Gillet test has recently been reported to indicate abnormal biomechanics on the stance side by Hungerford et al. Increased hamstring activation on the stance leg has been identified as indicative of abnormal SI motion. These two tests (ASLR and Gillet) are thought to be reflective of SIJ instability or abnormal movement in, respectively, pregnancy or low back patients.

• Study Type: Interventional
• Enrollment (Actual): 55
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Virginia
    • Charlottesville, Virginia, United States, 22908
      • UVA Pain Management Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 64 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patients presenting for sacroiliac injection with pain suspected from the sacroiliac joint

Exclusion Criteria:

• Pregnancy, allergy to contrast, inability to cooperate with screening tests, inability to understand the consent, either due to language barrier, or cognitive limitations, age > 64 years, inability to position themselves on the fluoro table for the procedure

Study Plan

How is the study designed?

Design Details

• Primary Purpose: HEALTH_SERVICES_RESEARCH
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
OTHER: measurements of gait; all subjects will undergo 6 tests to assess gait before and after SIJ; SIJ pain diagnostic tests	Other: SIJ pain diagnostic tests; 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; Other Names: back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Predictive values of 6 tests to assess gait parameters	Sensitivity, specificity, positive and negative predictive values will be calculated for each SIJ pain diagnostic test using values collected prior to and following the SIJ injection	Day one (after SIJ injection)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Scale for pain	the subject will fill out a Visual Analog Scale for pain before and after the SIJ injection	Day one (before and after SIJ injection)

Collaborators and Investigators

• Sponsor: University of Virginia
• Investigators: Principal Investigator: Robin Hamill-Ruth, MD, UVA Anesthesiology

Publications and helpful links

General Publications

• Broadhurst NA, Bond MJ. Pain provocation tests for the assessment of sacroiliac joint dysfunction. J Spinal Disord. 1998 Aug;11(4):341-5.
• Cibulka MT, Koldehoff R. Clinical usefulness of a cluster of sacroiliac joint tests in patients with and without low back pain. J Orthop Sports Phys Ther. 1999 Feb;29(2):83-9; discussion 90-2. doi: 10.2519/jospt.1999.29.2.83.
• Cibulka MT. Understanding sacroiliac joint movement as a guide to the management of a patient with unilateral low back pain. Man Ther. 2002 Nov;7(4):215-21. doi: 10.1054/math.2002.0474. No abstract available.
• Hungerford B, Gilleard W, Hodges P. Evidence of altered lumbopelvic muscle recruitment in the presence of sacroiliac joint pain. Spine (Phila Pa 1976). 2003 Jul 15;28(14):1593-600.
• Hungerford B, Gilleard W, Lee D. Altered patterns of pelvic bone motion determined in subjects with posterior pelvic pain using skin markers. Clin Biomech (Bristol, Avon). 2004 Jun;19(5):456-64. doi: 10.1016/j.clinbiomech.2004.02.004.
• Kokmeyer DJ, Van der Wurff P, Aufdemkampe G, Fickenscher TC. The reliability of multitest regimens with sacroiliac pain provocation tests. J Manipulative Physiol Ther. 2002 Jan;25(1):42-8. doi: 10.1067/mmt.2002.120418.
• Laslett M, Williams M. The reliability of selected pain provocation tests for sacroiliac joint pathology. Spine (Phila Pa 1976). 1994 Jun 1;19(11):1243-9. doi: 10.1097/00007632-199405310-00009.
• Laslett M. The value of the physical examination in diagnosis of painful sacroiliac joint pathologies. Spine (Phila Pa 1976). 1998 Apr 15;23(8):962-4. doi: 10.1097/00007632-199804150-00029. No abstract available.
• Laslett M, Young SB, Aprill CN, McDonald B. Diagnosing painful sacroiliac joints: A validity study of a McKenzie evaluation and sacroiliac provocation tests. Aust J Physiother. 2003;49(2):89-97. doi: 10.1016/s0004-9514(14)60125-2.
• Laslett M, Aprill CN, McDonald B, Young SB. Diagnosis of sacroiliac joint pain: validity of individual provocation tests and composites of tests. Man Ther. 2005 Aug;10(3):207-18. doi: 10.1016/j.math.2005.01.003.
• Laslett M, McDonald B, Tropp H, Aprill CN, Oberg B. Agreement between diagnoses reached by clinical examination and available reference standards: a prospective study of 216 patients with lumbopelvic pain. BMC Musculoskelet Disord. 2005 Jun 9;6:28. doi: 10.1186/1471-2474-6-28.
• Mens JM, Vleeming A, Snijders CJ, Stam HJ, Ginai AZ. The active straight leg raising test and mobility of the pelvic joints. Eur Spine J. 1999;8(6):468-73. doi: 10.1007/s005860050206.
• Mens JM, Vleeming A, Snijders CJ, Koes BW, Stam HJ. Reliability and validity of the active straight leg raise test in posterior pelvic pain since pregnancy. Spine (Phila Pa 1976). 2001 May 15;26(10):1167-71. doi: 10.1097/00007632-200105150-00015.
• Mens JM, Vleeming A, Snijders CJ, Koes BW, Stam HJ. Validity of the active straight leg raise test for measuring disease severity in patients with posterior pelvic pain after pregnancy. Spine (Phila Pa 1976). 2002 Jan 15;27(2):196-200. doi: 10.1097/00007632-200201150-00015.

Study record dates

Study Major Dates

• Study Start: February 1, 2009
• Primary Completion (ACTUAL): June 1, 2011
• Study Completion (ACTUAL): June 1, 2011

Study Registration Dates

• First Submitted: August 9, 2011
• First Submitted That Met QC Criteria: October 27, 2016
• First Posted (ESTIMATE): October 31, 2016

Study Record Updates

• Last Update Posted (ESTIMATE): October 31, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: August 1, 2011

More Information

Terms related to this study

• Keywords: pelvic girdle dysfunction
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: 14073

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO