Chronic Low Back PainSARA31143NCT02115009
The Sacroiliac Joint With SIJ Nerve Entrapments and Chronic Low Back Pain
An observational study of Chronic Low Back Pain, run by Carmel Medical Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Chronic Low Back Pain
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- Jun 2014to Dec 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Subjects (100 males and 100 females) with and without Low Back Pain
Who may be able to join
- -For the NSCLBP group - subjects with pain in the lower back region, pelvic area, hips, groin, abdominal, buttocks, and thighs
Who cannot join
- -Subjects with any level of lumbar disc bulging, spondyloarthropathy, diffuse idiopathic skeletal hyperostosis, spinal tumors, osteoporotic fractures, traumatic vertebral fractures, and previous spinal surgeries
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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.
- Conditions
- Chronic Low Back Pain
- Keywords
- sacroiliac joint lumbopelvic ,chronic low back pain
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Carmel Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Tel Aviv University
- Responsible party
- Principal investigator, Natan Peled, Carmel Medical Center
- Investigators
- Nathan Peled, MD, Principal investigator, Carmel Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02115009
- Sponsor's protocol ID
- CMC-13-0072-CTIL
- Acronym
- SARA31143
- Status last verified
- Apr 2014
- First submitted
- 13 Apr 2014
- Last updated
- 6 May 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 May 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study of The Relationship Between the Sacroiliac Joint (SIJ) and Lumbopelvic Configurations With SIJ Nerve Entrapments and Chronic Low Back Pain
- ClinicalTrials.gov ID
- NCT02115009
- Acronym / sponsor ID
- SARA31143 / CMC-13-0072-CTIL
- Conditions
- Chronic Low Back Pain
- Keywords
- sacroiliac joint lumbopelvic ,chronic low back pain
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Carmel Medical CenterUniversity, hospital or other
- Collaborators
- Tel Aviv University
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 15 Apr 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Subjects (100 males and 100 females) with and without Low Back Pain
Key inclusion criteria (1 listed)
- -For the NSCLBP group - subjects with pain in the lower back region, pelvic area, hips, groin, abdominal, buttocks, and thighs
Key exclusion criteria (1 listed)
- -Subjects with any level of lumbar disc bulging, spondyloarthropathy, diffuse idiopathic skeletal hyperostosis, spinal tumors, osteoporotic fractures, traumatic vertebral fractures, and previous spinal surgeries
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 May 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nathan Peled, MD principal investigator
Carmel Medical Center
Questions about this trial
What is this clinical trial studying?
An observational study of Chronic Low Back Pain, run by Carmel Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 May 2014. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nathan Peled, MD (97248250425, peled_natan@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of the recruited participants (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 May 2014.