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Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT01932307
Other study ID # H13-01151
Secondary ID
Status Withdrawn
Phase N/A
First received August 27, 2013
Last updated September 29, 2015
Start date December 2015
Est. completion date September 2016

Study information

Verified date September 2015
Source University of British Columbia
Contact n/a
Is FDA regulated No
Health authority Canada: Health Canada
Study type Interventional

Clinical Trial Summary

There are currently no standardized programs addressing the well-documented neck pain in surgeons as a result of non-ergonomic positioning and the use of microsurgical equipment. The primary goal of this study is to introduce a brief neck strengthening exercise program to optimize surgeons' neck health. Instructional videos outlining the program along with surveys designed to assess attitude towards neck health will be distributed to first year general surgery residents at the University of British Columbia (UBC) through their required online curriculum webpage. A followup survey will be administered 10 weeks later to determine efficacy of the program through self-reported adherence and changes in attitude towards neck health.


Description:

1. Purpose:

To evaluate the efficacy of a pre-operative 2-minute exercise program in reducing surgical residents self-reported neck pain.

2. 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.

3. 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.

4. Objectives:

1. Define the problem through prevalence data in a sample of surgeons.

2. Understand qualitatively and quantitatively measures of pain and quality on residents.

3. Evaluate the efficacy of a pre-operative 2-minute exercise program.

4. Disseminate our results and change the cultural norms of practice.

5. 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.

6. 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.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date September 2016
Est. primary completion date June 2016
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group N/A and older
Eligibility 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 Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Procedure:
Neck strengthening exercise program
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.

Locations

Country Name City State
Canada Vancouver General Hospital Vancouver British Columbia

Sponsors (1)

Lead Sponsor Collaborator
University of British Columbia

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Neck pain and quality of life questionnaires 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 No
Secondary Adherence and attitudes towards the exercise program 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 No
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