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

Completed

• Conditions: Lumbar Disc Herniation; Lumbar Degenerative Disease; Sarcopenia
• Interventions: Other: MRI with Eovist

• Registration Number: NCT06622356
• Lead Sponsor: Hao Liu

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

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-09
• Study Start: 2024-09-20
• Primary Completion: 2024-09-25
• Study Completion: 2024-09-28
• Study First Submitted: 2024-09-28
• Study First Submitted QC: 2024-10-01
• Last Update Submitted: 2024-10-01
• Study First Posted: 2024-10-02
• Last Update Posted: 2024-10-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 452

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

Primary Outcome Measures

Name	Time	Method
SAS（Pain rating scale）	12-18 months after surgery	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)

Trial Locations

Locations (1)

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