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

Completed

• Conditions: Lumbar Disc Herniation; Lumbar Degenerative Disease; Sarcopenia
• Interventions: Other: Magnetic Resonance Imaging with Contrast

• Registration Number: NCT06628583
• Lead Sponsor: Hao Liu

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-09-20
• Primary Completion: 2024-09-25
• Study Completion: 2024-09-28
• Status Verified: 2024-10
• Study First Submitted: 2024-10-03
• Study First Submitted QC: 2024-10-03
• Last Update Submitted: 2024-10-03
• Study First Posted: 2024-10-07
• Last Update Posted: 2024-10-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 936

Inclusion Criteria

1. 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;
2. lumbar spinal fusion surgical treatment with PLIF;
3. grouping based on the presence or absence of a lumbar or limb pain with VAS ≥3 at the 3th month postoperative follow-up;
4. 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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Rehabilitation Group	Magnetic Resonance Imaging with Contrast	mild/non pain group with VAS\<3 at 3th months after PLIF.N=501
Recurrent pain group	Magnetic Resonance Imaging with Contrast	Recurrent pain group: recurrent pain group with VAS≥3 at 3th months after PLIF.N=435

Primary Outcome Measures

Name	Time	Method
General situation of the patient	Before the operation	General information such as age, sex, BMI and psychological status was collected

Secondary Outcome Measures

Name	Time	Method
Surgical situation	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

Trial Locations

Locations (1)

Medical record system and imaging system of the First Affiliated Hospital of Suzhou University, China; 🇨🇳 Suzhou, Jiangsu, China