Risk Factors of Paraspinal Muscles in Degenerative Lumbar Spondylolisthesis (RFPMDLS)

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Spine Degeneration

• Study Type: Observational
• Enrollment (Estimated): 1000

Contacts and Locations

• Study Contact: Name: Xinyun Li; Phone Number: 86+15750359757; Email: 15750359757@163.com

Study Locations

• China
  • Yunnan
    • Kunming, Yunnan, China, 650032
      • The First People's Hospital of Yunnan

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-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.

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Group A; patients without lumbar spondylolisthesis
Group B; patients with lumbar spondylolisthesis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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).	Two weeks before treatment

Collaborators and Investigators

• Sponsor: The First People's Hospital of Yunnan

Study record dates

Study Major Dates

• Study Start (Estimated): March 6, 2025
• Primary Completion (Estimated): April 30, 2025
• Study Completion (Estimated): August 31, 2025

Study Registration Dates

• First Submitted: January 23, 2025
• First Submitted That Met QC Criteria: January 23, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 4, 2025
• Last Verified: January 1, 2025

More Information

Terms related to this study

• Keywords: MRI; paraspinal muscles; degenerative lumbar spondylolisthesis
• Additional Relevant MeSH Terms: Bone Diseases; Musculoskeletal Diseases; Spinal Diseases; Spondylolysis; Spondylosis; Spondylolisthesis
• Other Study ID Numbers: KHLL2025-KY047; 2024JSKFKT-17 (Other Grant/Funding Number: Yunnan Spinal Cord Disease Clinical Medical Center)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No