Disk Herniated LumbarNCT05245214
Muscle Analyze In Patient With Disc Herniation
An observational study of Disk Herniated Lumbar, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
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. Read more about this study
- Who is it for?
- Ages 20 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Disk Herniated Lumbar
- What is being tested?
- Magnetic Resonance Imaging
- How many people
- 330 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Mar 2021to 7 Jan 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients without disc herniation, severe disc degeneration and spondylolisthesis were also withdrawn from the System and included in the control group. 80 individuals with aged between 20-70 years included control group.
Who may be able to join
- 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.
Who cannot join
- Patients who had previous spinal surgery, patients with lumbar scoliosis, spondylolisthesis or structural defect in the sacrum were excluded from the study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Disk Herniated Lumbar
- Being tested
- Magnetic Resonance Imaging
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Magnetic Resonance ImagingDiagnostic test
Muscle analysis by Magnetic Resonance Imaging
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Magnetic Resonance Imaging | |
| Patient in control group | Patients without disc herniation, severe disc degeneration and spondylolisthesis were included in the control group. Receives: Diagnostic Test: Magnetic Resonance Imaging |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 Month
Secondary outcomes (1)
Lumbar Biomechanic
Biomechanic analysis was performed by measuring the sagittal curve using T2-weighted sagittal images.
Measured: 1 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Feb 2022
- Study start2 Mar 2021
- Primary completion1 Jan 2022
- Study completion7 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Disk Herniated LumbarStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Retrospective
- Enrolment
- 330 participants (actual)
Sponsor and investigators
- Lead sponsor
- Karamanoğlu Mehmetbey University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayşenur Gökşen, Karamanoğlu Mehmetbey University
- Investigators
- Ayşenur Gökşen, PhD, Principal investigator, Karamanoğlu Mehmetbey University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245214
- Sponsor's protocol ID
- 06-2021/30
- Status last verified
- Feb 2022
- First submitted
- 10 Jan 2022
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: This study was planned to investigate the factors affecting muscle which stabilize the lumbar region in the case of disc herniation.
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.
PubMed 28427393
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comprehensive Analysis Of Muscle Wasting In Disc Herniation
- ClinicalTrials.gov ID
- NCT05245214
- Acronym / sponsor ID
- 06-2021/30
- Conditions
- Disk Herniated Lumbar
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 330 participants (actual)
- Lead sponsor
- Karamanoğlu Mehmetbey UniversityUniversity, hospital or other
- Study start
- 2 Mar 2021 (actual)
- Primary completion
- 1 Jan 2022 (actual)
- Study completion
- 7 Jan 2022 (actual)
- First posted
- 17 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Observational model
- Case-control
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with disc herniation | – | Diagnostic Test: Magnetic Resonance ImagingHaving 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. |
| Patient in control group | – | Diagnostic Test: Magnetic Resonance ImagingPatients without disc herniation, severe disc degeneration and spondylolisthesis were included in the control group. |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (1 listed)
- Patients who had previous spinal surgery, patients with lumbar scoliosis, spondylolisthesis or structural defect in the sacrum were excluded from the study.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Magnetic Resonance ImagingMuscle analysis by Magnetic Resonance Imaging | Diagnostic test | Patient in control group, Patients with disc herniation |
Primary outcome
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 secondary outcome
Lumbar Biomechanic
Time frame: 1 Month
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Mar 2022.
- Background: PubMed 28427393Sun 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.
- Individual participant dataSharing planned: No. This study was planned to investigate the factors affecting muscle which stabilize the lumbar region in the case of disc herniation.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayşenur Gökşen, PhD principal investigator
Karamanoğlu Mehmetbey University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Disk Herniated Lumbar, run by Karamanoğlu Mehmetbey University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Muscle cross-area (time frame: 1 Month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05245214, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Mar 2022.