- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05245214
Muscle Analyze In Patient With Disc Herniation
February 23, 2022 updated by: Ayşenur Gökşen, Karamanoğlu Mehmetbey University
Comprehensive Analysis Of Muscle Wasting In Disc Herniation
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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 Type
Observational
Enrollment (Actual)
330
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Karaman, Turkey
- Karamanoglu Mehmetbey University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Sampling Method
Probability Sample
Study Population
Patients without disc herniation, severe disc degeneration and spondylolisthesis were also withdrawn from the System and included in the control group.
80 individuals with aged between 20-70 years included control group.
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Observational Models: Case-Control
- Time Perspectives: Retrospective
Cohorts and Interventions
Group / Cohort |
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.
|
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.
|
Muscle analysis by Magnetic Resonance Imaging
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Muscle cross-area
Time Frame: 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.
|
1 Month
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Lumbar Biomechanic
Time Frame: 1 Month
|
Biomechanic analysis was performed by measuring the sagittal curve using T2-weighted sagittal images.
|
1 Month
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Ayşenur Gökşen, PhD, Karamanoğlu Mehmetbey Üniversitesi
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
March 2, 2021
Primary Completion (Actual)
January 1, 2022
Study Completion (Actual)
January 7, 2022
Study Registration Dates
First Submitted
January 10, 2022
First Submitted That Met QC Criteria
February 16, 2022
First Posted (Actual)
February 17, 2022
Study Record Updates
Last Update Posted (Actual)
March 10, 2022
Last Update Submitted That Met QC Criteria
February 23, 2022
Last Verified
February 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 06-2021/30
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
IPD Plan Description
This study was planned to investigate the factors affecting muscle which stabilize the lumbar region in the case of disc herniation.
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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