Spine DegenerationRFPMDLSNCT06797700
Risk Factors of Paraspinal Muscles in Degenerative Lumbar Spondylolisthesis
An observational study of Spine Degeneration, run by The First People's Hospital of Yunnan at 1 site in China.
Trial summary
This is a retrospectively observational study. The goal of this observational study is to analyze the risk factors of paraspinal muscles associated with the occurrence of spondylolisthesis in patients with degenerative lumbar spondylolisthesis(DLS) and to construct a predictive model. Read more about this study
- Who is it for?
- Ages 50 to 80 years
- Conditions the study is for
- Spine Degeneration
- How many people
- 1,000 participants
- Where
- 1 siteChina
- Study dates
- 6 Mar 2025to 31 Aug 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 50 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients who have undergone lumbar MRI in our hospital and have been diagnosed with back pain ( including spondylolisthesis or no spondylolisthesis) during the period from 2022 to 2024.
Who may be able to join
- Patients who presented to our hospital with back pain(the diagnosis was spondylolisthesis or no spondylolisthesis);
- Patients older than 50 years;
- Patients with complete clinical data and magnetic resonance imaging (MRI) before surgery.
Who cannot join
- The patient has previous spinal surgery;
- Patients with lumbar tumor,lumbar infection and lumbar tuberculosis;
- Patients with incomplete MRI sequence.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Prediction of Risk Factors of Paraspinal Muscles in Degenerative Lumbar Spondylolisthesis Based on Spine MRI
This is a retrospectively observational study. The goal of this observational study is to analyze the risk factors of paraspinal muscles associated with the occurrence of spondylolisthesis in patients with degenerative lumbar spondylolisthesis(DLS) and to construct a predictive model. The main question it aims to answer is: Which paraspinal muscle changes are risk factors for DLS? We will collect the information of patients who have undergone lumbar MRI in our hospital and have been diagnosed with back pain ( including spondylolisthesis or no spondylolisthesis) during the period from 2022 to 2024.The collected data included gender, age, body mass index (BMI), diabetes, hypertension, occupation and imaging parameters. We will then retrospectively analyze the risk factors associated with lumbar spondylolisthesis.
- Conditions
- Spine Degeneration
- Keywords
- degenerative lumbar spondylolisthesis, paraspinal muscles, MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Group A | patients without lumbar spondylolisthesis | |
| Group B | patients with lumbar spondylolisthesis |
What is being measured
The primary outcome is the main question the study is designed to answer.
the MF FCSA
The functional cross-sectional areas of the multifidus muscl.Measurement it on axial T2-weighted magnetic resonance (MR) images from the L4 vertebral body levels
Measured: Two weeks before treatment
the ES FCSA
The functional cross-sectional areas of the erector spinae.Measurement it on axial T2-weighted magnetic resonance (MR) images from the L4 vertebral body levels
Measured: Two weeks before treatment
the MF CSA
the total cross-sectional areas of the multifidus muscl.Measurement it on axial T2-weighted magnetic resonance (MR) images from the L4 vertebral body levels
Measured: Two weeks before treatment
the ES CSA
the total cross-sectional areas of the erector spinae.Measurement it on axial T2-weighted magnetic resonance (MR) images from the L4 vertebral body levels
Measured: Two weeks before treatment
Secondary outcomes (1)
SMI
The skeletal muscle index.SMI = l CSA of muscle on an axial scan (expressed as cm2) divided by the square of the patient's height (expressed as cm2).
Measured: Two weeks before treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jan 2025
- Study start6 Mar 2025 (estimated)
- Primary completion30 Apr 2025 (estimated)
- Study completion31 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spine DegenerationStudies 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
- Other
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The First People's Hospital of Yunnan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xinyun li, The First People's Hospital of Yunnan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06797700
- Sponsor's protocol ID
- KHLL2025-KY047
- Other IDs
- 2024JSKFKT-17
- Acronym
- RFPMDLS
- Status last verified
- Jan 2025
- First submitted
- 23 Jan 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prediction of Risk Factors of Paraspinal Muscles in Degenerative Lumbar Spondylolisthesis Based on Spine MRI
- ClinicalTrials.gov ID
- NCT06797700
- Acronym / sponsor ID
- RFPMDLS / KHLL2025-KY047
- Conditions
- Spine Degeneration
- Keywords
- degenerative lumbar spondylolisthesis, paraspinal muscles, MRI
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- The First People's Hospital of YunnanUniversity, hospital or other
- Study start
- 6 Mar 2025 (estimated)
- Primary completion
- 30 Apr 2025 (estimated)
- Study completion
- 31 Aug 2025 (estimated)
- First posted
- 28 Jan 2025 (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 is a retrospectively observational study. The goal of this observational study is to analyze the risk factors of paraspinal muscles associated with the occurrence of spondylolisthesis in patients with degenerative lumbar spondylolisthesis(DLS) and to construct a predictive model. The main question it aims to answer is: Which paraspinal muscle changes are risk factors for DLS? We will collect the information of patients who have undergone lumbar MRI in our hospital and have been diagnosed with back pain ( including spondylolisthesis or no spondylolisthesis) during the period from 2022 to 2024.The collected data included gender, age, body mass index (BMI), diabetes, hypertension, occupation and imaging parameters. We will then retrospectively analyze the risk factors associated with lumbar spondylolisthesis.
Study design
- Observational model
- Other
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | – | –patients without lumbar spondylolisthesis |
| Group B | – | –patients with lumbar spondylolisthesis |
Who may qualify
- Ages
- 50 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients who have undergone lumbar MRI in our hospital and have been diagnosed with back pain ( including spondylolisthesis or no spondylolisthesis) during the period from 2022 to 2024.
Key inclusion criteria (3 listed)
- Patients who presented to our hospital with back pain(the diagnosis was spondylolisthesis or no spondylolisthesis);
- Patients older than 50 years;
- Patients with complete clinical data and magnetic resonance imaging (MRI) before surgery.
Key exclusion criteria (3 listed)
- The patient has previous spinal surgery;
- Patients with lumbar tumor,lumbar infection and lumbar tuberculosis;
- Patients with incomplete MRI sequence.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
the MF FCSA
Time frame: Two weeks before treatment
The functional cross-sectional areas of the multifidus muscl.Measurement it on axial T2-weighted magnetic resonance (MR) images from the L4 vertebral body levels
the ES FCSA
Time frame: Two weeks before treatment
The functional cross-sectional areas of the erector spinae.Measurement it on axial T2-weighted magnetic resonance (MR) images from the L4 vertebral body levels
the MF CSA
Time frame: Two weeks before treatment
the total cross-sectional areas of the multifidus muscl.Measurement it on axial T2-weighted magnetic resonance (MR) images from the L4 vertebral body levels
the ES CSA
Time frame: Two weeks before treatment
the total cross-sectional areas of the erector spinae.Measurement it on axial T2-weighted magnetic resonance (MR) images from the L4 vertebral body levels
1 secondary outcome
SMI
Time frame: Two weeks before treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2025.
- Individual participant dataSharing planned: No
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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.
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 Spine Degeneration, run by The First People's Hospital of Yunnan at 1 site in China.
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 3 inclusion and 3 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: opening soon, as of the sponsor's last update on 5 Mar 2025. 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 China. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Xinyun Li (86+15750359757, 15750359757@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the MF FCSA (time frame: Two weeks before treatment). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Mar 2025.