- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04555356
The Effect Of Low Back Pain on Paraspinal Muscles
September 19, 2020 updated by: fatma esra bahadir ulger, Fatih Sultan Mehmet Training and Research Hospital
The Effect of Low Back Pain on Paraspinal Muscle Volumes in Adolescents
Low back pain is frequently seen in the adolescent age group, with a prevalence approaching that of the adult age group.
The most common type is non-specific, self-limiting low back pain.
LDH is rare in children and adolescents and generally presents with low back pain, with or without radiculopathy.
The condition is usually unilateral (especially L4-5 or L5-S1).
LDH is also mostly central type.
Although there are many studies that have investigated the relationship between paraspinal muscle volumes and LBP and/or LDH in the adult age group, there are very few studies in adolescents.
The principal aim of this study was to compare MF, ES, and PM volumes in adolescents with LBP with and without LDH using magnetic resonance imaging (MRI) and to determine whether these two conditions cause paraspinal muscle volume loss.
Study Overview
Status
Completed
Conditions
Detailed Description
The medical records of 229 patients who underwent MRI due to low back pain persisting for a minimum of twelve weeks between January 2018 and January 2020 were evaluated retrospectively.
Twenty-four patients were excluded due to the presence of spondylolysis-listhesis, spinal alignment disorders including scoliosis and kyphosis, inflammatory diseases, or histories of spinal surgery and multilevel disc hernia.
Two hundred five patients were finally enrolled.
Age, gender, weight, and height were recorded, and BMI was calculated as weight/(height)².
Participants were divided into two groups - with LDH (Group A) and without LDH (Group B).
Right- and left-side PS, MF, and ES muscle volumes at intervertebral disc levels L4-L5 and L5-S1 were measured on Axial T2-weighted fast spin-echo sequences.
All cross-sectional images at both levels (L4-5 and L5-S1) were generated by means of multiplanar reformat images.
The muscles were identified by means of manual contouring at both disc levels.
The fat components were then eliminated by application of the threshold technique, based on visual differences in pixel signal intensities.
Volume measurement from cross-sectional images was based on the use of an automatic volume calculation tool.
Study Type
Observational
Enrollment (Actual)
205
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
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Atasehir
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Istanbul, Atasehir, Turkey, 34758
- Fatih Sultan Mehmet Training and Research Hospital
-
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
10 years to 18 years (Child, Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Non-Probability Sample
Study Population
The patients (aged 10-17) with low back pain persisting for a minimum of twelve weeks
Description
Inclusion Criteria:
- Aged 10-18
- LBP persisting for a minimum of twelve weeks
Exclusion Criteria:
- spondylolysis-listhesis
- spinal alignment disorders including scoliosis and kyphosis
- inflammatory diseases
- histories of spinal surgery
- multilevel disc hernia
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Evaluation of paraspinal muscle volumes in adolescents with LBP with and without LDH
Time Frame: 3 months
|
Multifidus, erector spina and psoas major muscle volumes were measured using T2 weighted axial MR images at L4-5 and L5-S1 intervertebral disc levels.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Fatma Esra Bahadir Ulger, Fatih Sultan Mehmet Training and Research Hospital
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2018
Primary Completion (Actual)
January 1, 2020
Study Completion (Actual)
January 1, 2020
Study Registration Dates
First Submitted
September 15, 2020
First Submitted That Met QC Criteria
September 15, 2020
First Posted (Actual)
September 18, 2020
Study Record Updates
Last Update Posted (Actual)
September 22, 2020
Last Update Submitted That Met QC Criteria
September 19, 2020
Last Verified
September 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- FSMTRHRF
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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