Biomechanics of Lumbar Region in Low Back Pain

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05095402
• Other study ID #: KU-ANA-ACD-01
• Status: Completed
• Start date: April 19, 2019
• Est. completion date: September 25, 2020

Study information

• Verified date: October 2021
• Source: Karabuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 96
• Est. completion date: September 25, 2020
• Est. primary completion date: June 30, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Locations

Country	Name	City	State
Turkey	Karabuk University	Karabük

Sponsors (1)

Lead Sponsor	Collaborator
Karabuk University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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