Influence of Pain Sensitivity on Lumbar Surgery Outcomes
1 other identifier
observational
171
1 country
1
Brief Summary
Pain sensitivity would be associated with surgical outcomes after lumbar spine surgery.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jun 2012
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2014
CompletedFirst Submitted
Initial submission to the registry
May 6, 2014
CompletedFirst Posted
Study publicly available on registry
May 9, 2014
CompletedMay 9, 2014
May 1, 2014
1.8 years
May 6, 2014
May 7, 2014
Conditions
Outcome Measures
Primary Outcomes (1)
Oswestry Disability Index
up to 12 months after operation
Secondary Outcomes (3)
Visual Analog Pain Scale for back pain
up to 12 months after operation
Visual Analog Pain Scale for leg pain
up to 12 months after operation
Short-Form 36
up to 12 months after operation
Study Arms (2)
Low pain sensitivity group
total Pain Sensitivity Questionnaire score \<6.5
High pain sensitivity group
total pain sensitivity questionnaire score ≥ 6.5
Interventions
decompression with or without fusion for lumbar spinal stenosis
Eligibility Criteria
The inclusion criteria were the following: 1) patients aged 40-80 years; 2) an lumbar spinal stenosis diagnosis and scheduled spine surgery at a tertiary-care teaching institution between June 2012 and April 2013
You may qualify if:
- patients aged 40-80 years
- lumbar spinal stenosis diagnosis and scheduled spine surgery at a tertiary-care teaching institution between June 2012 and April 2013
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Seoul National University Bundang Hospital
Sung-Nam, Gyeonggi-do, 463-707, South Korea
Related Publications (1)
Kim HJ, Park JW, Kang KT, Chang BS, Lee CK, Kang SS, Yeom JS. Determination of the Optimal Cutoff Values for Pain Sensitivity Questionnaire Scores and the Oswestry Disability Index for Favorable Surgical Outcomes in Subjects With Lumbar Spinal Stenosis. Spine (Phila Pa 1976). 2015 Oct 15;40(20):E1110-6. doi: 10.1097/BRS.0000000000001023.
PMID: 26076437DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Jin S. Yeom, MD
Seoul National University Bundang Hospital
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
May 6, 2014
First Posted
May 9, 2014
Study Start
June 1, 2012
Primary Completion
April 1, 2014
Study Completion
April 1, 2014
Last Updated
May 9, 2014
Record last verified: 2014-05