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Clinical Trials/NCT00719485
NCT00719485
Unknown
N/A

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

Sunnybrook Health Sciences Centre0 sites70 target enrollmentApril 2009

Overview

Phase
N/A
Intervention
Not specified
Conditions
Decompression, Surgical
Sponsor
Sunnybrook Health Sciences Centre
Enrollment
70
Primary Endpoint
Functional outcome scores
Last Updated
17 years ago

Overview

Brief 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

Detailed 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.

Registry
clinicaltrials.gov
Start Date
April 2009
End Date
February 2011
Last Updated
17 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Eligibility Criteria

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

Outcomes

Primary Outcomes

Functional outcome scores

Time Frame: 2 years following surgery

Secondary Outcomes

  • Quality of life scores(2 years following surgery)

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