Influence of Pain Sensitivity on Lumbar Surgery Outcomes

Overview

Pain sensitivity would be associated with surgical outcomes after lumbar spine surgery.

Full Title of Study: “Influence of Pain Sensitivity on Surgical Outcomes After Lumbar Spine Surgery in Patients With Lumbar Spinal Stenosis”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 2014

Interventions

  • Procedure: Surgery for lumbar spinal stenosis
    • decompression with or without fusion for lumbar spinal stenosis

Arms, Groups and Cohorts

  • Low pain sensitivity group
    • total Pain Sensitivity Questionnaire score <6.5
  • High pain sensitivity group
    • total pain sensitivity questionnaire score ≥ 6.5

Clinical Trial Outcome Measures

Primary Measures

  • Oswestry Disability Index
    • Time Frame: up to 12 months after operation

Secondary Measures

  • Visual Analog Pain Scale for back pain
    • Time Frame: up to 12 months after operation
  • Visual Analog Pain Scale for leg pain
    • Time Frame: up to 12 months after operation
  • Short-Form 36
    • Time Frame: up to 12 months after operation
    • measurement of general health status

Participating in This Clinical Trial

Inclusion Criteria

1. patients aged 40-80 years 2. lumbar spinal stenosis diagnosis and scheduled spine surgery at a tertiary-care teaching institution between June 2012 and April 2013 Exclusion Criteria:

  • a history of major psychiatric disorders (schizophrenia, major depression) or peripheral vascular disease – any concurrent serious medical condition that would cause disability or decreased general health status such as sepsis or cancer.

Gender Eligibility: All

Minimum Age: 40 Years

Maximum Age: 80 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Seoul National University Hospital
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jin S. Yeom, Professor – Seoul National University Hospital
  • Overall Official(s)
    • Jin S. Yeom, MD, Study Director, Seoul National University Bundang Hospital

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