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OpenTrials
Completed

NCT Number: NCT06622356

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

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

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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 12-18 month postoperative follow-up;
  • 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.

Treatment and study plan

MRI with Eovist

Other

The study was retrospective and did not design an intervention

Primary outcomes

  1. SAS(Pain rating scale)

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Hao Liu

Other

Registry information

Important dates

Study start
2024
Primary completion
2024
Study completion
2024
First posted
Oct 2, 2024
Registry last updated
Oct 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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