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

NCT06628583 — Completed, 936 participants, Hao Liu

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Registry	NCT06628583
Status	Completed
Study type	Observational
Enrollment	936 (Actual)
Sponsor	Hao Liu (Other)
Conditions	Lumbar Disc Herniation, Lumbar Degenerative Disease, Sarcopenia
Interventions	Magnetic Resonance Imaging with Contrast (Other)
Dates	start 2024-09-20, primary completion 2024-09-25, completion 2024-09-28, first posted 2024-10-08, last updated 2024-10-08
Locations	1 site in China

-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.

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+Arms and interventions

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

Magnetic Resonance Imaging with Contrast (Other): The study was retrospective and did not set interventions

+Outcome measures

Primary outcomes

General situation of the patient [Before the operation]: General information such as age, sex, BMI and psychological status was collected

Secondary outcomes

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

+Eligibility

Sex: All, accepts healthy volunteers

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.

+Locations (1)

Facility	City	Country	Status
Medical record system and imaging system of the First Affiliated Hospital of Suzhou University, China	Suzhou, Jiangsu	China