Low Back PainNCT04555356
The Effect Of Low Back Pain on Paraspinal Muscles
An observational study of Low Back Pain, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Low Back Pain
- How many people
- 205 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2018to 1 Jan 2020
- 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 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Study population: The patients (aged 10-17) with low back pain persisting for a minimum of twelve weeks
Who may be able to join
- Aged 10-18
- LBP persisting for a minimum of twelve weeks
Who cannot join
- spondylolysis-listhesis
- spinal alignment disorders including scoliosis and kyphosis
- inflammatory diseases
- histories of spinal surgery
- multilevel disc hernia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Fatih Sultan Mehmet Training and Research Hospital
Istanbul, Atasehir, 34758
About this study
Official title: 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.
Read the 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.
- Conditions
- Low Back Pain
- Keywords
- adolescent, low back pain, lumbar disc herniation, paraspinal muscle, magnetic resonance imaging
- Medical subject headings
- Low Back Pain, Intervertebral Disc Displacement
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of paraspinal muscle volumes in adolescents with LBP with and without LDH
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.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start1 Jan 2018
- Primary completion1 Jan 2020
- Study completion1 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 only
- Time perspective
- Retrospective
- Enrolment
- 205 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fatih Sultan Mehmet Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, fatma esra bahadir ulger, Fatih Sultan Mehmet Training and Research Hospital
- Investigators
- Fatma Esra Bahadir Ulger, Principal investigator, Fatih Sultan Mehmet Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04555356
- Sponsor's protocol ID
- FSMTRHRF
- Status last verified
- Sep 2020
- First submitted
- 15 Sep 2020
- Last updated
- 22 Sep 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Low Back Pain on Paraspinal Muscle Volumes in Adolescents
- ClinicalTrials.gov ID
- NCT04555356
- Acronym / sponsor ID
- FSMTRHRF
- Conditions
- Low Back Pain
- Keywords
- adolescent, low back pain, lumbar disc herniation, paraspinal muscle, magnetic resonance imaging
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 205 participants (actual)
- Lead sponsor
- Fatih Sultan Mehmet Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2018 (actual)
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 1 Jan 2020 (actual)
- First posted
- 18 Sep 2020 (actual)
- 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.
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.
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 design
- Observational model
- Case only
- Time perspective
- Retrospective
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
- Study population
- The patients (aged 10-17) with low back pain persisting for a minimum of twelve weeks
Key inclusion criteria (2 listed)
- Aged 10-18
- LBP persisting for a minimum of twelve weeks
Key exclusion criteria (5 listed)
- spondylolysis-listhesis
- spinal alignment disorders including scoliosis and kyphosis
- inflammatory diseases
- histories of spinal surgery
- multilevel disc hernia
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
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2020.
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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.
Fatma Esra Bahadir Ulger principal investigator
Fatih Sultan Mehmet Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Low Back Pain, run by Fatih Sultan Mehmet Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 5 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: finished, as of the sponsor's last update on 22 Sep 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of paraspinal muscle volumes in adolescents with LBP with and without LDH (time frame: 3 months). 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 22 Sep 2020.