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Influence of Pain Sensitivity on Lumbar Surgery Outcomes

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ClinicalTrials.gov Identifier: NCT02134821
Recruitment Status : Completed
First Posted : May 9, 2014
Last Update Posted : May 9, 2014
Sponsor:
Information provided by (Responsible Party):
Jin S. Yeom, Seoul National University Hospital

Tracking Information
First Submitted Date May 6, 2014
First Posted Date May 9, 2014
Last Update Posted Date May 9, 2014
Study Start Date June 2012
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 7, 2014)
Oswestry Disability Index [ Time Frame: up to 12 months after operation ]
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures
 (submitted: May 7, 2014)
  • 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
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Influence of Pain Sensitivity on Lumbar Surgery Outcomes
Official Title Influence of Pain Sensitivity on Surgical Outcomes After Lumbar Spine Surgery in Patients With Lumbar Spinal Stenosis
Brief Summary Pain sensitivity would be associated with surgical outcomes after lumbar spine surgery.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population 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
Condition Lumbar Spinal Stenosis
Intervention Procedure: Surgery for lumbar spinal stenosis
decompression with or without fusion for lumbar spinal stenosis
Study Groups/Cohorts
  • Low pain sensitivity group
    total Pain Sensitivity Questionnaire score <6.5
    Intervention: Procedure: Surgery for lumbar spinal stenosis
  • High pain sensitivity group
    total pain sensitivity questionnaire score ≥ 6.5
    Intervention: Procedure: Surgery for lumbar spinal stenosis
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: May 7, 2014)
171
Original Actual Enrollment Same as current
Actual Study Completion Date April 2014
Actual Primary Completion Date April 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria

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.
Sex/Gender
Sexes Eligible for Study: All
Ages 40 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number NCT02134821
Other Study ID Numbers PSQ_001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Jin S. Yeom, Seoul National University Hospital
Study Sponsor Seoul National University Hospital
Collaborators Not Provided
Investigators
Study Director: Jin S. Yeom, MD Seoul National University Bundang Hospital
PRS Account Seoul National University Hospital
Verification Date May 2014