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

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ClinicalTrials.gov Identifier: NCT02115009
Recruitment Status : Unknown
Verified April 2014 by Natan Peled, Carmel Medical Center.
Recruitment status was:  Not yet recruiting
First Posted : April 15, 2014
Last Update Posted : May 6, 2014
Sponsor:
Collaborator:
Tel Aviv University
Information provided by (Responsible Party):
Natan Peled, Carmel Medical Center

Brief Summary:
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.

Condition or disease
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
Estimated Enrollment : 200 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Comparative Study of The Relationship Between the Sacroiliac Joint (SIJ) and Lumbopelvic Configurations With SIJ Nerve Entrapments and Chronic Low Back Pain
Study Start Date : June 2014
Estimated Primary Completion Date : December 2016
Estimated Study Completion Date : December 2017





Primary Outcome Measures :
  1. Percentage of the recruited participants [ Time Frame: 1 year ]
    1 year after the starting point of the study the investigators are expecting at least 35% recruiting of the study participants



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Ages Eligible for Study:   20 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Subjects (100 males and 100 females) with and without Low Back Pain
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02115009


Contacts
Contact: Nathan Peled, MD 97248250425 peled_natan@clalit.org.il

Sponsors and Collaborators
Carmel Medical Center
Tel Aviv University
Investigators
Principal Investigator: Nathan Peled, MD Carmel Medical Center

Responsible Party: Natan Peled, Prof. Nathan Peled, Carmel Medical Center
ClinicalTrials.gov Identifier: NCT02115009     History of Changes
Other Study ID Numbers: CMC-13-0072-CTIL
First Posted: April 15, 2014    Key Record Dates
Last Update Posted: May 6, 2014
Last Verified: April 2014

Keywords provided by Natan Peled, Carmel Medical Center:
sacroiliac joint lumbopelvic ,chronic low back pain

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Nerve Compression Syndromes
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Peripheral Nervous System Diseases
Neuromuscular Diseases