Muscle Analyze In Patient With Disc Herniation

Sponsor

Karamanoğlu Mehmetbey University (Other)

Overall Status

Completed

CT.gov ID

NCT05245214

Collaborator

(none)

330

Enrollment

Location

10.2

Actual Duration (Months)

32.3

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Disk Herniated Lumbar	Diagnostic Test: Magnetic Resonance Imaging

Detailed 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.

Study Design

Study Type:

Observational

Actual Enrollment :

330 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

Comprehensive Analysis Of Muscle Wasting In Disc Herniation

Actual Study Start Date :

Mar 2, 2021

Actual Primary Completion Date :

Jan 1, 2022

Actual Study Completion Date :

Jan 7, 2022

Arms and Interventions

Arm	Intervention/Treatment
Patients with disc herniation 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.	Diagnostic Test: Magnetic Resonance Imaging Muscle analysis by Magnetic Resonance Imaging
Patient in control group Patients without disc herniation, severe disc degeneration and spondylolisthesis were included in the control group.	Diagnostic Test: Magnetic Resonance Imaging Muscle analysis by Magnetic Resonance Imaging

Arm

Intervention/Treatment

Patients with disc herniation

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.

Diagnostic Test: Magnetic Resonance Imaging

Muscle analysis by Magnetic Resonance Imaging

Patient in control group

Patients without disc herniation, severe disc degeneration and spondylolisthesis were included in the control group.

Diagnostic Test: Magnetic Resonance Imaging

Muscle analysis by Magnetic Resonance Imaging

Outcome Measures

Primary Outcome Measures

Muscle cross-area [1 Month]
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.

Secondary Outcome Measures

Lumbar Biomechanic [1 Month]
Biomechanic analysis was performed by measuring the sagittal curve using T2-weighted sagittal images.

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Karamanoğlu Mehmetbey University	Karaman		Turkey

Sponsors and Collaborators

Karamanoğlu Mehmetbey University

Investigators

Principal Investigator: Ayşenur Gökşen, PhD, Karamanoğlu Mehmetbey Üniversitesi

Study Documents (Full-Text)

None provided.

More Information

Publications

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.

Responsible Party:

Ayşenur Gökşen, Assistant Prof, Karamanoğlu Mehmetbey University

ClinicalTrials.gov Identifier:

NCT05245214

Other Study ID Numbers:

06-2021/30

First Posted:

Feb 17, 2022

Last Update Posted:

Mar 10, 2022

Last Verified:

Feb 1, 2022

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Intervertebral Disc Displacement

Study Results

No Results Posted as of Mar 10, 2022