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

Primary Purpose

Back Pain

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
SIJ pain diagnostic tests
Sponsored by
University of Virginia
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional health services research trial for Back Pain focused on measuring pelvic girdle dysfunction

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • UVA Pain Management Center

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

measurements of gait

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Visual Analog Scale for pain
the subject will fill out a Visual Analog Scale for pain before and after the SIJ injection

Full Information

First Posted
August 9, 2011
Last Updated
October 27, 2016
Sponsor
University of Virginia
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1. Study Identification

Unique Protocol Identification Number
NCT02950129
Brief Title
IRB-HSR # 14073 Investigation of Pelvic Girdle Dysfunction in the Low Back Pain Population
Official Title
IRB-HSR # 14073 Investigation of Pelvic Girdle Dysfunction in the Low Back Pain Population
Study Type
Interventional

2. Study Status

Record Verification Date
August 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
June 2011 (Actual)
Study Completion Date
June 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Virginia

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Back Pain
Keywords
pelvic girdle dysfunction

7. Study Design

Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Actual)

8. Arms, Groups, and Interventions

Arm Title
measurements of gait
Arm Type
Other
Arm Description
all subjects will undergo 6 tests to assess gait before and after SIJ; SIJ pain diagnostic tests
Intervention Type
Other
Intervention Name(s)
SIJ pain diagnostic tests
Other Intervention Name(s)
back pain
Intervention Description
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
Primary Outcome Measure Information:
Title
Predictive values of 6 tests to assess gait parameters
Description
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
Time Frame
Day one (after SIJ injection)
Secondary Outcome Measure Information:
Title
Visual Analog Scale for pain
Description
the subject will fill out a Visual Analog Scale for pain before and after the SIJ injection
Time Frame
Day one (before and after SIJ injection)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Hamill-Ruth, MD
Organizational Affiliation
UVA Anesthesiology
Official's Role
Principal Investigator
Facility Information:
Facility Name
UVA Pain Management Center
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22908
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
9726305
Citation
Broadhurst NA, Bond MJ. Pain provocation tests for the assessment of sacroiliac joint dysfunction. J Spinal Disord. 1998 Aug;11(4):341-5.
Results Reference
background
PubMed Identifier
10322583
Citation
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.
Results Reference
background
PubMed Identifier
12481788
Citation
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.
Results Reference
background
PubMed Identifier
12865851
Citation
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.
Results Reference
background
PubMed Identifier
15182980
Citation
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.
Results Reference
background
PubMed Identifier
11898017
Citation
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.
Results Reference
background
PubMed Identifier
8073316
Citation
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.
Results Reference
background
PubMed Identifier
9580969
Citation
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.
Results Reference
background
PubMed Identifier
12775204
Citation
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.
Results Reference
background
PubMed Identifier
16038856
Citation
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.
Results Reference
background
PubMed Identifier
15943873
Citation
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.
Results Reference
background
PubMed Identifier
10664304
Citation
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.
Results Reference
background
PubMed Identifier
11413432
Citation
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.
Results Reference
background
PubMed Identifier
11805667
Citation
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.
Results Reference
background

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

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