- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01932307
Cervical Spine Health of Surgeons
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Purpose:
To evaluate the efficacy of a pre-operative 2-minute exercise program in reducing surgical residents self-reported neck pain.
Hypothesis:
A 10 week 2-minute neck strengthening exercise program completed between cases will reduce self-reported chronic neck pain caused by the use of surgical instruments and increase musculoskeletal health awareness in a group of residents.
Justification:
Surgical residents will be asked to complete a baseline survey regarding their self-rated neck pain. Then they will be introduced to a 2-minute neck strengthening exercise to be performed in between surgical cases. They will be asked to evaluate their neck pain again 10 weeks later.
Neck pain experience before and after the introduction of neck exercises will be compared.
Objectives:
- Define the problem through prevalence data in a sample of surgeons.
- Understand qualitatively and quantitatively measures of pain and quality on residents.
- Evaluate the efficacy of a pre-operative 2-minute exercise program.
- Disseminate our results and change the cultural norms of practice.
Research Method:
All first year general surgery residents at the University of British Columbia will be invited to participate. They will be asked to complete a survey regarding neck pain experience and introduced to a 2-minute neck muscle exercise video which they will be advised to follow for the next 10 weeks. Another follow-up survey will be sent at the end of 10 weeks.
- Statistical analysis:
Percentage of residents showing >50% improvement using an alpha of 0.05 statistical significance will be the primary outcome measure using the appropriate validated pain questionnaire. The attitude of the residents towards their neck health before the intervention will be compared to their attitudes at the completion of the study using a Pearson's chi squared test as a measure of significant difference. The self-reported effectiveness and adherence of the program at the completion of the study will be used as a measure of efficacy. All statistical analysis will be conducted in SAS 9.3.
Study Type
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- All first year general surgery residents at the University of British Columbia
Exclusion Criteria:
- Previous serious neck injury (e.g. herniated disc)
- Chest pain during physical exercise
- Heart failure
- Spinal Stenosis
- Radicular nerve pain
- Neurological condition causing chronic pain
- Currently involved directly with the study group
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: PGY1 General Surgery Residents
All first year general surgery residents at the University of British Columbia
|
Study subjects will be introduced to a 2-minute neck strengthening exercise program and advised to follow for 10 weeks.
The exercise program will include five different exercises that will strengthen the neck and stabilize the scapula.
The exercises are: Chin retraction, cracking the egg, scapular clock, wall pushup and scapula retraction.
Each will be completed as 3 isometric holds, 3 repetitions per set and 2 sets per exercise.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Neck pain and quality of life questionnaires
Time Frame: 10 weeks
|
The subjects will be asked to complete the Bournemouth Neck Disability index online once at the start of the study and again following a 10 week period where the subjects will be encouraged to follow our exercise routine in between surgical cases.
|
10 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Adherence and attitudes towards the exercise program
Time Frame: 10 weeks
|
A followup survey will be distributed 10 weeks following the exposure to the exercise program to determine self-reported adherence and attitudes to the program.
|
10 weeks
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: York NH Hsiang, MB MHSc FRCSC, Professor of Surgery, Division of Vascular Surgery, Department of Surgery
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- H13-01151
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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