Multivariate Analysis and Machine Learning Model Risk Prediction of Recurrent Pain After PLIF Surgery for Degenerative Lumbar Spine Disease At Long-term Follow-up

NCT06622356 | Completed

• 1 other identifier: (2024) Lun Yan Grant No. 517
• Study Type: observational
• Target: 452
• Locations: 1 country
• Sites: 1

Brief Summary

The study was a clinical retrospective study designed to investigate risk factors for long-term recurrent pain after PLIF in patients with lumbar degenerative disease and to improve patient outcomes

Conditions

Lumbar Disc Herniation; Lumbar Degenerative Disease; Sarcopenia

Keywords

Lumbar Degenerative disease; PLIF; Sarcopenia; Sagittal balance; Machine learning; SVM; Cross Validation

Outcome Measures

Primary Outcomes (1)

• SAS（Pain rating scale）

  The visual analogue scale (VAS) was employed to determine the patient's perception of lower back pain or lower limb pain prior to surgery, as well as 12-18 months after surgery. (0-10 scale, with 0 being painless and 10 being the most painful)

  12-18 months after surgery

Study Arms (2)

Rehabilitation Group

Rehabilitation Group (n = 268): mild/non pain group with VAS\<3 at 12-18 months after PLIF。The study was retrospective and did not design an intervention

Other: MRI with Eovist

Recurrent pain group

Recurrent pain group (n = 184): recurrent pain group with VAS≥3 at 12-18 months after PLIF

Other: MRI with Eovist

Interventions

MRI with Eovist OTHER

The study was retrospective and did not design an intervention

Recurrent pain group; Rehabilitation Group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study retrospectively reviewed 452 patients suffering from degenerative lumbar spinedisorders in our institute between January 2019 and February 2023. The patients were separated into Recurrent pain group and Rehabilitation Group. Recurrent pain group (n = 268): mild/non pain group with VAS\<3 at 12-18 months after PLIF；Rehabilitation Group (n = 184): recurrent pain group with VAS≥3 at 12-18 months after PLIF.

You may qualify if:

• 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 12-18 month postoperative follow-up;
• observational indicators including individual factors, surgical factors, spine-pelvis sagittal balance parameters, and paravertebral muscle parameters.

You may not qualify if:

• (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.

Sponsors & Collaborators

• Hao Liu: lead

Study Sites (1)

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

Suzhou, Jiangsu, 215006, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Biological samples were not designed for this study

MeSH Terms

Conditions

Intervertebral Disc Displacement; Sarcopenia

Interventions

Magnetic Resonance Spectroscopy; gadolinium ethoxybenzyl DTPA

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Hernia; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Orthopedic surgeon, First Affiliated Hospital of Suzhou University, Jiangsu Province, China

Study Record Dates

• First Submitted: September 28, 2024
• First Posted: October 2, 2024
• Study Start: September 20, 2024
• Primary Completion: September 25, 2024
• Study Completion: September 28, 2024
• Last Updated: October 2, 2024

Record last verified: 2024-09

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)