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

October 3, 2024 updated by: Hao Liu
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

936

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • Medical record system and imaging system of the First Affiliated Hospital of Suzhou University, China

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Rehabilitation Group
mild/non pain group with VAS<3 at 3th months after PLIF.N=501
Other: Magnetic Resonance Imaging with Contrast
The study was retrospective and did not set interventions
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
The study was retrospective and did not set interventions

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
General situation of the patient
Time Frame: Before the operation
General information such as age, sex, BMI and psychological status was collected
Before the operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Surgical situation
Time Frame: 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
1-3 months after surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hao Liu

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 20, 2024

Primary Completion (Actual)

September 25, 2024

Study Completion (Actual)

September 28, 2024

Study Registration Dates

First Submitted

October 3, 2024

First Submitted That Met QC Criteria

October 3, 2024

First Posted (Actual)

October 8, 2024

Study Record Updates

Last Update Posted (Actual)

October 8, 2024

Last Update Submitted That Met QC Criteria

October 3, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • (2024) Lun Yan Grant No. 518

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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