Lumbar Spinal Stenosis Clinical Trial
Official title:
Influence of Pain Sensitivity on Surgical Outcomes After Lumbar Spine Surgery in Patients With Lumbar Spinal Stenosis
Verified date | May 2014 |
Source | Seoul National University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | Korea: Food and Drug Administration |
Study type | Observational |
Pain sensitivity would be associated with surgical outcomes after lumbar spine surgery.
Status | Completed |
Enrollment | 171 |
Est. completion date | April 2014 |
Est. primary completion date | April 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 40 Years to 80 Years |
Eligibility |
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. |
Observational Model: Cohort, Time Perspective: Prospective
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Seoul National University Bundang Hospital | Sung-Nam | Gyeonggi-do |
Lead Sponsor | Collaborator |
---|---|
Seoul National University Hospital |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Oswestry Disability Index | up to 12 months after operation | No | |
Secondary | Visual Analog Pain Scale for back pain | up to 12 months after operation | No | |
Secondary | Visual Analog Pain Scale for leg pain | up to 12 months after operation | No | |
Secondary | Short-Form 36 | measurement of general health status | up to 12 months after operation | No |
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