NCT04555356

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
205

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

September 15, 2020

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 18, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

2 years

First QC Date

September 15, 2020

Last Update Submit

September 19, 2020

Conditions

Keywords

adolescentlow back painlumbar disc herniationparaspinal musclemagnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

  • 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.

    3 months

Eligibility Criteria

Age10 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

The patients (aged 10-17) with low back pain persisting for a minimum of twelve weeks

You may qualify if:

  • Aged 10-18
  • LBP persisting for a minimum of twelve weeks

You may not qualify if:

  • spondylolysis-listhesis
  • spinal alignment disorders including scoliosis and kyphosis
  • inflammatory diseases
  • histories of spinal surgery
  • multilevel disc hernia

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Fatih Sultan Mehmet Training and Research Hospital

Istanbul, Atasehir, 34758, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back PainIntervertebral Disc Displacement

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsSpinal DiseasesBone DiseasesMusculoskeletal DiseasesHerniaPathological Conditions, Anatomical

Study Officials

  • Fatma Esra Bahadir Ulger

    Fatih Sultan Mehmet Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

September 15, 2020

First Posted

September 18, 2020

Study Start

January 1, 2018

Primary Completion

January 1, 2020

Study Completion

January 1, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations