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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05245214
Other study ID # 06-2021/30
Secondary ID
Status Completed
Phase
First received
Last updated
Start date March 2, 2021
Est. completion date January 7, 2022

Study information

Verified date February 2022
Source Karamanoglu Mehmetbey University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

This study which was planned to investigate the factors affecting m. erector spinae (ES), m. multifidus (MF), m. psoas major (PM) and m. quadratus lumborum (QL), which stabilize the lumbar region in the case of disc herniation. In this study, the effects of disc herniation, herniation severity, age, and spinal biomechanics were investigated.


Description:

This study was carried out on 330 individuals with and without lumbar disc herniation. All individuals were divided into 3 groups according to their age. The inclusion criteria: Having only disc degeneration and not having any other neurological or orthopedic disease. Patients who had previous spinal surgery, patients with lumbar scoliosis, spondylolisthesis or structural defect in the sacrum were excluded from the study.


Recruitment information / eligibility

Status Completed
Enrollment 330
Est. completion date January 7, 2022
Est. primary completion date January 1, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 20 Years to 70 Years
Eligibility Inclusion Criteria: - Having only disc degeneration and not having any other neurological or orthopedic disease. Patients who had previous spinal surgery, patients with lumbar scoliosis, spondylolisthesis or structural defect in the sacrum were excluded from the study. Exclusion Criteria: - Patients who had previous spinal surgery, patients with lumbar scoliosis, spondylolisthesis or structural defect in the sacrum were excluded from the study.

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Magnetic Resonance Imaging
Muscle analysis by Magnetic Resonance Imaging

Locations

Country Name City State
Turkey Karamanoglu Mehmetbey University Karaman

Sponsors (1)

Lead Sponsor Collaborator
Karamanoglu Mehmetbey University

Country where clinical trial is conducted

Turkey, 

References & Publications (1)

Sun D, Liu P, Cheng J, Ma Z, Liu J, Qin T. Correlation between intervertebral disc degeneration, paraspinal muscle atrophy, and lumbar facet joints degeneration in patients with lumbar disc herniation. BMC Musculoskelet Disord. 2017 Apr 20;18(1):167. doi: 10.1186/s12891-017-1522-4. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Muscle cross-area The cross-sectional area of the Multifidus, Erector Spina, Quadratus Lumborum, and Psoas Major muscles on both sides were measured using the T2-weighted axial Magnetig Resonance Imaging. 1 Month
Secondary Lumbar Biomechanic Biomechanic analysis was performed by measuring the sagittal curve using T2-weighted sagittal images. 1 Month
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