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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

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

Condition or disease Intervention/treatment
Lumbar Spinal Stenosis Procedure: Surgery for lumbar spinal stenosis

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Study Type : Observational
Actual Enrollment : 171 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Influence of Pain Sensitivity on Surgical Outcomes After Lumbar Spine Surgery in Patients With Lumbar Spinal Stenosis
Study Start Date : June 2012
Actual Primary Completion Date : April 2014
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine


Group/Cohort Intervention/treatment
Low pain sensitivity group
total Pain Sensitivity Questionnaire score <6.5
Procedure: Surgery for lumbar spinal stenosis
decompression with or without fusion for lumbar spinal stenosis

High pain sensitivity group
total pain sensitivity questionnaire score ≥ 6.5
Procedure: Surgery for lumbar spinal stenosis
decompression with or without fusion for lumbar spinal stenosis




Primary Outcome Measures :
  1. Oswestry Disability Index [ Time Frame: up to 12 months after operation ]

Secondary Outcome Measures :
  1. Visual Analog Pain Scale for back pain [ Time Frame: up to 12 months after operation ]
  2. Visual Analog Pain Scale for leg pain [ Time Frame: up to 12 months after operation ]
  3. Short-Form 36 [ Time Frame: up to 12 months after operation ]
    measurement of general health status



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Ages Eligible for Study:   40 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02134821


Locations
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Korea, Republic of
Seoul National University Bundang Hospital
Sung-Nam, Gyeonggi-do, Korea, Republic of, 463-707
Sponsors and Collaborators
Seoul National University Hospital
Investigators
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Study Director: Jin S. Yeom, MD Seoul National University Bundang Hospital
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Jin S. Yeom, Professor, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT02134821    
Other Study ID Numbers: PSQ_001
First Posted: May 9, 2014    Key Record Dates
Last Update Posted: May 9, 2014
Last Verified: May 2014
Additional relevant MeSH terms:
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Spinal Stenosis
Constriction, Pathologic
Pathological Conditions, Anatomical
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases