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Completed

NCT Number: NCT06628583

Multivariate Analysis and Risk Factors Were Used to Predict the Short-term Postoperative Pain of Degenerative Lumbar Spine

The objective of this retrospective clinical study wasto study the risk factors for short-term low back and leg pain after PLIF in patients with lumbar Degenerative disease, and to establish a risk prediction model for short-term low back and leg pain after PLIF based on relevant risk factors.

Completed

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Key information

Conditions

Lumbar Disc Herniation Atrophy Bone Diseases Hernia Intervertebral Disc Displacement Lumbar Degenerative Disease Muscular Atrophy Musculoskeletal Diseases Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Sarcopenia Signs and Symptoms Spinal Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

Medical record system and imaging system of the First Affiliated Hospital of Suzhou University, China

Suzhou, Jiangsu, 215006, China

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • confirmed diagnosis of lumbar degenerative disease (spinal stenosis, disc herniation with lumbar instability, and lumbar spondylolisthesis), with no significant symptomatic relief after conservative treatment for more than 3 months, and in need of surgical intervention;
  • lumbar spinal fusion surgical treatment with PLIF;
  • grouping based on the presence or absence of a lumbar or limb pain with VAS ≥3 at the 3th month postoperative follow-up;
  • observational indicators including individual factors, surgical factors, spine-pelvis sagittal balance parameters, and paravertebral muscle parameters.

Exclusion criteria

(1) those with a history of lumbar spine trauma, inflammation, tumor, or surgery; (2) those with congenital or acquired severe lumbar vertebral deformity; (3) those with severe neurological dysfunction; (4) those with incomplete baseline and follow-up data.

Treatment and study plan

Magnetic Resonance Imaging with Contrast

Other

The study was retrospective and did not set interventions

Primary outcomes

  1. General situation of the patient

    Time frame: Before the operation

    General information such as age, sex, BMI and psychological status was collected

Secondary outcomes

  1. Surgical situation

    Time frame: 1-3 months after surgery

    It includes the course of disease, the operation time, the amount of bone cement injected during the operation, the leakage of bone cement and so on

Sponsors and collaborators

Lead sponsor

Hao Liu

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 8, 2024
Registry last updated
Oct 8, 2024

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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