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NCT Number: NCT06797700

Risk Factors of Paraspinal Muscles in Degenerative Lumbar Spondylolisthesis

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.

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Key information

Conditions

Spine Degeneration

Age range

50 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First People's Hospital of Yunnan

Kunming, Yunnan, 650032, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Secondary outcomes

  1. SMI

    Time frame: Two weeks before treatment

    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).

Study contacts

Contact information is provided by the study sponsor or research team.

Xinyun Li

CONTACT

[email protected]

86+15750359757

Sponsors and collaborators

Lead sponsor

The First People's Hospital of Yunnan

Other

Registry information

Official study title

Prediction of Risk Factors of Paraspinal Muscles in Degenerative Lumbar Spondylolisthesis Based on Spine MRI

Acronym: RFPMDLS

Important dates

Study start
2025
Primary completion
2025
Study completion
2025
First posted
Jan 28, 2025
Registry last updated
Mar 5, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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