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
|Condition or disease|
|Chronic Low Back Pain|
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|
|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|
- 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
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
|Contact: Nathan Peled, MDfirstname.lastname@example.org|
|Principal Investigator:||Nathan Peled, MD||Carmel Medical Center|