NCT06797700

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
1,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Mar 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 23, 2025

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 28, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

March 6, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 30, 2025

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 31, 2025

Completed
Last Updated

March 5, 2025

Status Verified

January 1, 2025

Enrollment Period

2 months

First QC Date

January 23, 2025

Last Update Submit

March 4, 2025

Conditions

Keywords

degenerative lumbar spondylolisthesisparaspinal musclesMRI

Outcome Measures

Primary Outcomes (4)

  • 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

    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

    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

    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

    Two weeks before treatment

Secondary Outcomes (1)

  • SMI

    Two weeks before treatment

Study Arms (2)

Group A

patients without lumbar spondylolisthesis

Group B

patients with lumbar spondylolisthesis

Eligibility Criteria

Age50 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
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.

You may qualify if:

  • 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.

You may not qualify if:

  • The patient has previous spinal surgery;
  • Patients with lumbar tumor,lumbar infection and lumbar tuberculosis;
  • Patients with incomplete MRI sequence.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The First People's Hospital of Yunnan

Kunming, Yunnan, 650032, China

Location

Central Study Contacts

Study Design

Study Type
observational
Observational Model
OTHER
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
miss

Study Record Dates

First Submitted

January 23, 2025

First Posted

January 28, 2025

Study Start

March 6, 2025

Primary Completion

April 30, 2025

Study Completion

August 31, 2025

Last Updated

March 5, 2025

Record last verified: 2025-01

Data Sharing

IPD Sharing
Will not share

Locations