NCT05095402

Brief Summary

The purpose of this study was to examine the relationship between non-specific low back pain (NSLBP) and lumbar lordosis angle (LLA) and lumbar muscle thickness (LMT) by evaluating magnetic resonance images (MRI) in individuals with LBP.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
96

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2019

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

April 19, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2019

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 25, 2020

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

September 14, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 27, 2021

Completed
Last Updated

October 27, 2021

Status Verified

October 1, 2021

Enrollment Period

2 months

First QC Date

September 14, 2021

Last Update Submit

October 14, 2021

Conditions

Keywords

Low Back PainLumbar Lordosis AngleMagnetic Resonance ImagingMuscle Thickness

Outcome Measures

Primary Outcomes (3)

  • Disability caused by low back pain assessed by Oswestry Low Back Pain Disability Questionnaire

    Low back pain disability is assessed with Oswestry Low Back Pain Disability Questionnaire. Oswestry Disability Index (ODI) score as a percentage is obtained from the questionnaire result.

    6 months

  • Lumbar lordosis angle

    * Measured with the COBB angle method as LLA degree. * It is determined by looking at the angle between the vertebrae forming the lumbar lordosis curvature (L1-L5). * All radiological measurements are performed on the RAdiant DICOM viewer program.

    6 months

  • Muscles thickness measurements

    * Measured on the horizontal plane corresponding to the L3-L4 level in the sagittal plane. * Bilaterally, the thickest parts of the muscles are measured anterior-posterior and transverse and recorded in millimetres (mm). * All radiological measurements are performed on the RAdiant DICOM viewer program. * Muscles measured are listed below: * m. psoas major * m. multifidus * m. erector spinae muscles * m. quadratus lumborum

    6 months

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

The study included a total of 96 individuals, 43 males, and 53 females, who applied to the Department of Radiology of the Karabuk University Training and Research Hospital between March-June 2019 with complaints of LBP.

You may qualify if:

  • The age range of 18-65
  • Having non-specific LBP
  • Volunteering to participate in the study

You may not qualify if:

  • Having any psychiatric and mental problems
  • The presence of any disc, bone, and muscular pathology in the lumbar region
  • Having any previous operation on the lumbar region

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Karabuk University

Karabük, 78050, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Low Back Pain

Condition Hierarchy (Ancestors)

Back PainPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Ali dagli

    Karabuk University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
PROSPECTIVE
Target Duration
1 Day
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

September 14, 2021

First Posted

October 27, 2021

Study Start

April 19, 2019

Primary Completion

June 30, 2019

Study Completion

September 25, 2020

Last Updated

October 27, 2021

Record last verified: 2021-10

Data Sharing

IPD Sharing
Will not share

Locations