Influence of Pain Sensitivity on Lumbar Surgery Outcomes

Lumbar Spinal Stenosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02134821
• Other study ID #: PSQ_001
• 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

• Lumbar Spinal Stenosis
• Spinal Stenosis

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