Influence of Pain Sensitivity on Lumbar Surgery Outcomes

NCT ID: NCT02134821

Last Updated: 2014-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

171 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-06-30

Study Completion Date

2014-04-30

Brief Summary

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

Detailed Description

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Conditions

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Lumbar Spinal Stenosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Low pain sensitivity group

total Pain Sensitivity Questionnaire score \<6.5

Surgery for lumbar spinal stenosis

Intervention Type PROCEDURE

decompression with or without fusion for lumbar spinal stenosis

High pain sensitivity group

total pain sensitivity questionnaire score ≥ 6.5

Surgery for lumbar spinal stenosis

Intervention Type PROCEDURE

decompression with or without fusion for lumbar spinal stenosis

Interventions

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Surgery for lumbar spinal stenosis

decompression with or without fusion for lumbar spinal stenosis

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Jin S. Yeom

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jin S. Yeom, MD

Role: STUDY_DIRECTOR

Seoul National University Bundang Hospital

Locations

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Seoul National University Bundang Hospital

Sung-Nam, Gyeonggi-do, South Korea

Site Status

Countries

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South Korea

References

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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.

Reference Type DERIVED
PMID: 26076437 (View on PubMed)

Other Identifiers

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PSQ_001

Identifier Type: -

Identifier Source: org_study_id

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