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

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ClinicalTrials.gov Identifier: NCT00719485
Recruitment Status : Unknown
Verified July 2008 by Sunnybrook Health Sciences Centre.
Recruitment status was:  Not yet recruiting
First Posted : July 21, 2008
Last Update Posted : February 6, 2009
Sponsor:
Information provided by:
Sunnybrook Health Sciences Centre

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

Condition or disease Intervention/treatment Phase
Decompression, Surgical Other: Educational program Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 70 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
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
Study Start Date : April 2009
Estimated Primary Completion Date : February 2011
Estimated Study Completion Date : February 2011

Arm Intervention/treatment
Experimental: 1
Educational program
Other: Educational program
Informing patients about their condition, treatment options, prioritization on the wait list, and post-operative care

No Intervention: 2
Standard care



Primary Outcome Measures :
  1. Functional outcome scores [ Time Frame: 2 years following surgery ]

Secondary Outcome Measures :
  1. Quality of life scores [ Time Frame: 2 years following surgery ]


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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00719485


Contacts
Contact: Albert Yee, MD 416-480-6815 albert.yee@sunnybrook.ca

Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Albert Yee, MD Sunnybrook Health Sciences Centre

Responsible Party: Albert Yee, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT00719485     History of Changes
Other Study ID Numbers: Yee_1
First Posted: July 21, 2008    Key Record Dates
Last Update Posted: February 6, 2009
Last Verified: July 2008

Keywords provided by Sunnybrook Health Sciences Centre:
lumbar decompression