The Sacroiliac Joint With SIJ Nerve Entrapments and Chronic Low Back Pain (SARA31143)

Comparative Study of The Relationship Between the Sacroiliac Joint (SIJ) and Lumbopelvic Configurations With SIJ Nerve Entrapments and Chronic Low Back Pain

The overall goal of this study is to characterize the SIJ form, function, nerve entrapments, lumbo-pelvic configuration and their possible relationships with nonspecific chronic LBP in females and males. Specific aims: 1.To investigate the relationship between SIJ bridging and NSCLBP in females and males. 2. To investigate the prevalence and characterization of nerve entrapment of the lumbar sacral plexus around the SIJ in females and males. 3. To investigate the correlation between the lumbar sacral plexus nerve entrapments around the SIJ and NSCLBP in females and males. 4. To investigate the relationship between the lumbar sacral plexus nerve entrapments around the SIJ and lumbo-pelvic morphology in females and males. 5. To characterize the location and severity of articular degenerative changes in the SIJ and its relationship with lumbo-pelvic morphology in females and males. 6. To investigate the relationship between articular degenerative changes in the SIJ and LBP in females and males.

Study Overview

• Status: Unknown
• Conditions: Chronic Low Back Pain

Detailed Description

Background: Low back pain is a major cause of disability among the working population significantly impacting the socioeconomic status. Pelvic girdle structures, mainly the sacroiliac joint, may act as major factors in LBP. The interaction, however, between possible adjacent nerve entrapments around the SIJ, osteological changes in the SIJ and their relationship with the lumbo-pelvic configuration in patients with and without nonspecific chronic LBP is still unclear. Studying this interaction radiologically, histologically, anatomically and clinically will significantly improve our understanding of the pathophysiology of lumbo-pelvic pain and improve its diagnosis and medical treatment.

Methods: The research project includes four major studies: Radiological and clinical studies- Computerized tomography images of the lumbo-pelvic region of 200 individuals age range 20-50 years, admitted to the Carmel Medical Center with and without LBP will be examined prospectively to evaluate the relationship between the SIJ structures, lumbo-pelvic nerve pathways, lumbo-pelvic configuration and SIJ osteological changes. The presence and prevalence of nerve entrapments in these phenomena will be assessed using a CT software distance measurement tool. All individuals will be referred by their physicians for CT regardless the purposes of the current study thus no extra radiations will be required. Inclusion criteria for the NSCLBP group are individuals with pain in the lower back region, pelvic area, hips, groin, abdominal, buttocks, and thighs. Individuals with the following spinal conditions will be excluded: Any level of lumbar disc bulging, spondyloarthropathy, diffuse idiopathic skeletal hyperostosis, spinal tumors, osteoporotic fractures, traumatic vertebral fractures, and previous spinal surgeries. All CT images will be obtained from the Department of Radiology, and will be analyzed at the Spinal Research Lab. The interaction between the above mentioned radiological parameters and clinical self-reported lumbo-pelvic pain questionnaires will be assessed. Anatomical/histological studies - The morphological study of the lumbo-pelvic nerve pathways will be carried out on human cadavers at the Tel-Aviv University. The histological study of the SIJ microstructure will be carried out on samples taken from human cadavers at the Department of Anatomy, TAU.

• Study Type: Observational
• Enrollment (Anticipated): 200

Contacts and Locations

• Study Contact: Name: Nathan Peled, MD; Phone Number: 97248250425; Email: peled_natan@clalit.org.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 50 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects (100 males and 100 females) with and without Low Back Pain

Description

Inclusion Criteria:

-For the NSCLBP group - subjects with pain in the lower back region, pelvic area, hips, groin, abdominal, buttocks, and thighs

Exclusion Criteria:

-Subjects with any level of lumbar disc bulging, spondyloarthropathy, diffuse idiopathic skeletal hyperostosis, spinal tumors, osteoporotic fractures, traumatic vertebral fractures, and previous spinal surgeries

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of the recruited participants	1 year after the starting point of the study the investigators are expecting at least 35% recruiting of the study participants	1 year

Collaborators and Investigators

• Sponsor: Carmel Medical Center
• Collaborators: Tel Aviv University
• Investigators: Principal Investigator: Nathan Peled, MD, Carmel Medical Center

Study record dates

Study Major Dates

• Study Start: June 1, 2014
• Primary Completion (Anticipated): December 1, 2016
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: April 13, 2014
• First Submitted That Met QC Criteria: April 14, 2014
• First Posted (Estimate): April 15, 2014

Study Record Updates

• Last Update Posted (Estimate): May 6, 2014
• Last Update Submitted That Met QC Criteria: May 5, 2014
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: sacroiliac joint lumbopelvic ,chronic low back pain
• Additional Relevant MeSH Terms: Nervous System Diseases; Pain; Neurologic Manifestations; Neuromuscular Diseases; Peripheral Nervous System Diseases; Back Pain; Low Back Pain; Nerve Compression Syndromes
• Other Study ID Numbers: CMC-13-0072-CTIL