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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