A Study on the Use of Educational Programs Prior to Lumbar Spinal Surgery

Decompression, Surgical Clinical Trial

Official title:

A Prospective Randomized Control Trial Assessing the Effect of Two Different Educational Programs on Functional Outcome and Quality of Life Scores for Patients Having Posterior Decompressive Lumbar Spinal Surgery for Degenerative Conditions of the Lumbar Spine

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00719485
• Other study ID #: Yee_1
• Status: Not yet recruiting
• Phase: N/A
• First received: July 17, 2008
• Last updated: February 5, 2009
• Start date: April 2009
• Est. completion date: February 2011

Study information

• Verified date: July 2008
• Source: Sunnybrook Health Sciences Centre
• Contact: Albert Yee, MD
• Phone: 416-480-6815
• Email: albert.yee[@]sunnybrook.ca
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This study evaluated the hypothesis that the implementation of an educational program that informs spine patients about their condition, treatment options, prioritization on the wait list, and post-operative care would improve functional outcome and quality of life scores following surgery

Description:

Previous literature has shown that longer waits to lumbar spine surgery can have negative effects on the patients perceived function and quality of life both pre- and post-operatively. Patients report deterioration during this long wait, commonly over 6 months in Ontario. The proposed study intends to evaluate the impact of two different educational methods for patients undergoing lumbar spine surgery. This prospective randomized clinical trial will assign patients to two different educational groups: one of solely standard care, and the other of standard care with the addition of presentation of a 10 minute educational video informing spine patients about their condition, treatment options, prioritization on the wait list and post-operative care. Outcome measures will be assessed through four different questionnaires concerning specific conditions, pain, quality of life, etc., both pre-operatively and post-operatively. Providing patients with this accurate information may coincide with positive outcome measures. The more successful educational program, as found by this study, may then be provided to all spine patients. This educational program may bring about an increase in overall well-being of spine patients by having a positive impact on the quality of life both pre- and post-operatively.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 70
• Est. completion date: February 2011
• Est. primary completion date: February 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Degenerative condition of the lumbar spine requiring decompressive surgery

Exclusion Criteria:

• emergent spinal condition

• acute bowel/bladder dysfunction

• cervical spine condition

• inability to participate in follow up and/or functional tests or questionnaires during study timeline (due to substance abuse, etc...)

• revision surgery

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Decompression, Surgical

Intervention

Other:
• Educational program
Informing patients about their condition, treatment options, prioritization on the wait list, and post-operative care

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Sunnybrook Health Sciences Centre

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Functional outcome scores		2 years following surgery	No
Secondary	Quality of life scores		2 years following surgery	No