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Completed

NCT Number: NCT05095402

Biomechanics of Lumbar Region in Low Back Pain

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.

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Key information

Conditions

Low Back Pain Back Pain Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Karabuk University

Karabük, 78050, Turkey (Türkiye)

About this study

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. Individuals' sociodemographic information and medical history were recorded using the LBP assessment form. The Oswestry LBP Disability Questionnaire was used for LBP. Thickness measurements of muscle (m.) psoas major, m. multifidus, m. quadratus lumborum and m. erector spinae were taken on MRI corresponding to the L3-L4 vertebra level. Cobb Angle method was used for LLA determination. Measurements were made in three repetitions using the Radiant DICOM viewer program, and their averages were recorded.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • 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

Treatment and study plan

Primary outcomes

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

    Time frame: 6 months

    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.

  2. Lumbar lordosis angle

    Time frame: 6 months

    • 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.

  3. Muscles thickness measurements

    Time frame: 6 months

    • 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

Sponsors and collaborators

Lead sponsor

Karabuk University

Other

Registry information

Official study title

Evaluation of the Relationship Between Lumbar Lordosis Angle and Lumbar Muscle Thickness With Non-Specific Low Back Pain

Important dates

Study start
2019
Primary completion
2019
Study completion
2020
First posted
Oct 27, 2021
Registry last updated
Oct 27, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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