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

NCT ID: NCT00719485

Last Updated: 2009-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-02-28

Brief Summary

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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

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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.

Conditions

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Decompression, Surgical

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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1

Educational program

Group Type EXPERIMENTAL

Educational program

Intervention Type OTHER

Informing patients about their condition, treatment options, prioritization on the wait list, and post-operative care

2

Standard care

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Educational program

Informing patients about their condition, treatment options, prioritization on the wait list, and post-operative care

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sunnybrook Health Sciences Centre

OTHER

Sponsor Role lead

Responsible Party

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Sunnybrook Health Sciences Centre

Principal Investigators

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Albert Yee, MD

Role: PRINCIPAL_INVESTIGATOR

Sunnybrook Health Sciences Centre

Central Contacts

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Albert Yee, MD

Role: CONTACT

416-480-6815

Other Identifiers

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Yee_1

Identifier Type: -

Identifier Source: org_study_id

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