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

NCT06628583 | Completed

• 1 other identifier: (2024) Lun Yan Grant No. 518
• Study Type: observational
• Target: 936
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lumbar Disc Herniation; Lumbar Degenerative Disease; Sarcopenia

Keywords

Lumbar Degenerative disease; PLIF; Sarcopenia; Sagittal bit balance; Machine learning

Outcome Measures

Primary Outcomes (1)

• General situation of the patient

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

  Before the operation

Secondary Outcomes (1)

• Surgical situation

  1-3 months after surgery

Study Arms (2)

Rehabilitation Group

mild/non pain group with VAS\<3 at 3th months after PLIF.N=501

Other: Magnetic Resonance Imaging with Contrast

Recurrent pain group

Recurrent pain group: recurrent pain group with VAS≥3 at 3th months after PLIF.N=435

Other: Magnetic Resonance Imaging with Contrast

Interventions

Magnetic Resonance Imaging with Contrast OTHER

The study was retrospective and did not set interventions

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

The data of 936 patients who underwent PLIF for lumbar Degenerative disease from June 2018 to March 2023 were collected retrospectively. The patients were divided into rehabilitation group（N=501） and residual pain group（N=435）according to their postoperative pain

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 3th 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, China

Suzhou, Jiangsu, 215006, China

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

The study did not involve biological samples

MeSH Terms

Conditions

Intervertebral Disc Displacement; Sarcopenia

Interventions

Magnetic Resonance Spectroscopy; Contrast Media

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; Diagnostic Uses of Chemicals; Pharmacologic Actions; Chemical Actions and Uses; Specialty Uses of Chemicals

Study Design

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

Study Record Dates

• First Submitted: October 3, 2024
• First Posted: October 8, 2024
• Study Start: September 20, 2024
• Primary Completion: September 25, 2024
• Study Completion: September 28, 2024
• Last Updated: October 8, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share

Locations

CN (1)