ClinicalTrials.gg
Status unknownNCT00719485Updated Feb 6, 2009

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

An interventional study of Educational program in Decompression, Surgical, sponsored by Sunnybrook Health Sciences Centre. Status unknown. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2009-02-06.

Sponsored by Sunnybrook Health Sciences Centre · Not applicable, Interventional, and Supportive care

The sponsor has not verified this record recently (last verified Jul 2008), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
70
Allocation
Randomized
Ages
18 Years to 80 Years
Sex
All
01

Study 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

Read the 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.

02

Conditions studied

  • Decompression, Surgical

Keywords

  • lumbar decompression
03

In context

Lead sponsor

Sunnybrook Health Sciences Centre is the lead sponsor of 582 studies on the registry; 133 are open to participants now.

Of its 6 completed or terminated interventional studies of FDA-regulated products, 2 (33%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 80 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Degenerative condition of the lumbar spine requiring decompressive surgery

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Supportive care
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
70 participants (estimated)

Study arms

  • Experimental
    1

    Educational program

    Other: Educational program

  • No intervention
    2

    Standard care

Interventions

  • OtherEducational program

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

06

What researchers measure

Primary outcomes

  1. Functional outcome scores

    Time frame: 2 years following surgery

Secondary outcomes

  1. Quality of life scores

    Time frame: 2 years following surgery

07

Study locations

No study locations are listed for this record.

08

Timeline

Tracking since Sep 25, 2026
Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Apr 2009, a primary completion of Feb 2011 and a completion of Feb 2011. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 17, 2008
First posted
Jul 21, 2008
Start
Apr 2009
Primary completionEst.
Feb 2011
CompletionEst.
Feb 2011
Last update
Feb 6, 2009
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Feb 6, 2009, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT00719485
First posted
Jul 21, 2008
Start date
Apr 2009
Primary completion
Feb 2011 (estimated)
Completion
Feb 2011 (estimated)
Last update
Feb 6, 2009

Study contacts

Albert Yee, MD
Contact
albert.yee@sunnybrook.ca
416-480-6815
Albert Yee, MD
principal investigator · Sunnybrook Health Sciences Centre

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jul 2008. You cannot join it, but the record below documents what was studied.

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