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

February 5, 2009 updated by: Sunnybrook Health Sciences Centre

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

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

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: 2
Standard care
Experimental: 1
Educational program
Other: Educational program
Informing patients about their condition, treatment options, prioritization on the wait list, and post-operative care

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Functional outcome scores
Time Frame: 2 years following surgery
2 years following surgery

Secondary Outcome Measures

Outcome Measure
Time Frame
Quality of life scores
Time Frame: 2 years following surgery
2 years following surgery

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sunnybrook Health Sciences Centre

Investigators

  • Principal Investigator: Albert Yee, MD, Sunnybrook Health Sciences Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2009

Primary Completion (Anticipated)

February 1, 2011

Study Completion (Anticipated)

February 1, 2011

Study Registration Dates

First Submitted

July 17, 2008

First Submitted That Met QC Criteria

July 18, 2008

First Posted (Estimate)

July 21, 2008

Study Record Updates

Last Update Posted (Estimate)

February 6, 2009

Last Update Submitted That Met QC Criteria

February 5, 2009

Last Verified

July 1, 2008

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • Yee_1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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