Decompression, SurgicalNCT00719485
A Study on the Use of Educational Programs Prior to Lumbar Spinal Surgery
A study testing Educational program in people with Decompression, Surgical, run by Sunnybrook Health Sciences Centre.
Trial 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 more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Decompression, Surgical
- What is being tested?
- Educational program
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Apr 2009to Feb 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Degenerative condition of the lumbar spine requiring decompressive surgery
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
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
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.
- Conditions
- Decompression, Surgical
- Being tested
- Educational program
- Keywords
- lumbar decompression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Educational programOther
Informing patients about their condition, treatment options, prioritization on the wait list, and post-operative care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Educational program Receives: Other: Educational program |
| 2 | No intervention | Standard care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Functional outcome scores
Measured: 2 years following surgery
Secondary outcomes (1)
Quality of life scores
Measured: 2 years following surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2008 (estimated)
- Study startApr 2009
- Primary completionFeb 2011 (estimated)
- Study completionFeb 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Decompression, SurgicalStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Investigators
- Albert Yee, MD, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00719485
- Sponsor's protocol ID
- Yee_1
- Status last verified
- Jul 2008
- First submitted
- 17 Jul 2008
- Last updated
- 6 Feb 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00719485
- Acronym / sponsor ID
- Yee_1
- Conditions
- Decompression, Surgical
- Keywords
- lumbar decompression
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Feb 2011 (estimated)
- Study completion
- Feb 2011 (estimated)
- First posted
- 21 Jul 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Other: Educational programEducational program |
| 2 | No intervention | –Standard care |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Degenerative condition of the lumbar spine requiring decompressive surgery
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Educational programInforming patients about their condition, treatment options, prioritization on the wait list, and post-operative care | Other | 1 |
Primary outcome
Functional outcome scores
Time frame: 2 years following surgery
1 secondary outcome
Quality of life scores
Time frame: 2 years following surgery
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2009.
Related trials for Decompression, Surgical
Not yet recruitingPhase 2
Omitting Nasogastric Tube Decompression in Minimally Invasive Pancreaticoduodenectomy
Pancreaticoduodenectomy, Nasogastric Tube Decompression
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Albert Yee, MD principal investigator
Sunnybrook Health Sciences Centre
Questions about this trial
What is this clinical trial studying?
A study testing Educational program in people with Decompression, Surgical, run by Sunnybrook Health Sciences Centre.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Albert Yee, MD (416-480-6815, albert.yee@sunnybrook.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Functional outcome scores (time frame: 2 years following surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2009; AzTrials last refreshed its copy on 2 Nov 2026.