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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02134821
Other study ID # PSQ_001
Secondary ID
Status Completed
Phase N/A
First received May 6, 2014
Last updated May 7, 2014
Start date June 2012
Est. completion date April 2014

Study information

Verified date May 2014
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Observational

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 171
Est. completion date April 2014
Est. primary completion date April 2014
Accepts healthy volunteers No
Gender Both
Age group 40 Years to 80 Years
Eligibility 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 Design

Observational Model: Cohort, Time Perspective: Prospective


Related Conditions & MeSH terms


Intervention

Procedure:
Surgery for lumbar spinal stenosis
decompression with or without fusion for lumbar spinal stenosis

Locations

Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Sung-Nam Gyeonggi-do

Sponsors (1)

Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary Oswestry Disability Index up to 12 months after operation No
Secondary Visual Analog Pain Scale for back pain up to 12 months after operation No
Secondary Visual Analog Pain Scale for leg pain up to 12 months after operation No
Secondary Short-Form 36 measurement of general health status up to 12 months after operation No
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