Influence of Pain Sensitivity on Lumbar Surgery Outcomes

May 7, 2014 updated by: Jin S. Yeom, Seoul National University Hospital

Influence of Pain Sensitivity on Surgical Outcomes After Lumbar Spine Surgery in Patients With Lumbar Spinal Stenosis

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

171

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Gyeonggi-do
      • Sung-Nam, Gyeonggi-do, Korea, Republic of, 463-707
        • Seoul National University Bundang Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Oswestry Disability Index
Time Frame: up to 12 months after operation
up to 12 months after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual Analog Pain Scale for back pain
Time Frame: up to 12 months after operation
up to 12 months after operation
Visual Analog Pain Scale for leg pain
Time Frame: up to 12 months after operation
up to 12 months after operation
Short-Form 36
Time Frame: up to 12 months after operation
measurement of general health status
up to 12 months after operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Study Director: Jin S. Yeom, MD, Seoul National University Bundang Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

June 1, 2012

Primary Completion (Actual)

April 1, 2014

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

May 6, 2014

First Submitted That Met QC Criteria

May 7, 2014

First Posted (Estimate)

May 9, 2014

Study Record Updates

Last Update Posted (Estimate)

May 9, 2014

Last Update Submitted That Met QC Criteria

May 7, 2014

Last Verified

May 1, 2014

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PSQ_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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