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

NCT02950129 | Completed Phase 2

• 1 other identifier: 14073
• Study Type: interventional
• Target: 55
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Back Pain

Keywords

pelvic girdle dysfunction

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Visual Analog Scale for pain

  Day one (before and after SIJ injection)

Study Arms (1)

measurements of gait

OTHER

all subjects will undergo 6 tests to assess gait before and after SIJ; SIJ pain diagnostic tests

Other: SIJ pain diagnostic tests

Interventions

SIJ pain diagnostic tests OTHER

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

Also known as: back pain

measurements of gait

Eligibility Criteria

• Age: 18 Years - 64 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Virginia: lead

Study Sites (1)

UVA Pain Management Center

Charlottesville, Virginia, 22908, United States

Location

Related Publications (14)

• Broadhurst NA, Bond MJ. Pain provocation tests for the assessment of sacroiliac joint dysfunction. J Spinal Disord. 1998 Aug;11(4):341-5.

  PMID: 9726305 BACKGROUND

• 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.

  PMID: 10322583 BACKGROUND

• 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.

  PMID: 12481788 BACKGROUND

• 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.

  PMID: 12865851 BACKGROUND

• 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). 2004 Jun;19(5):456-64. doi: 10.1016/j.clinbiomech.2004.02.004.

  PMID: 15182980 BACKGROUND

• 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.

  PMID: 11898017 BACKGROUND

• 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.

  PMID: 8073316 BACKGROUND

• 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.

  PMID: 9580969 BACKGROUND

• 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.

  PMID: 12775204 BACKGROUND

• 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.

  PMID: 16038856 BACKGROUND

• 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.

  PMID: 15943873 BACKGROUND

• 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.

  PMID: 10664304 BACKGROUND

• 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.

  PMID: 11413432 BACKGROUND

• 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.

  PMID: 11805667 BACKGROUND

MeSH Terms

Conditions

Back Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Robin Hamill-Ruth, MD

  UVA Anesthesiology

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Attending Anesthesiologist

Study Record Dates

• First Submitted: August 9, 2011
• First Posted: October 31, 2016
• Study Start: February 1, 2009
• Primary Completion: June 1, 2011
• Study Completion: June 1, 2011
• Last Updated: October 31, 2016

Record last verified: 2011-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)