Occupational Health PhysiciansNCT01932307
Cervical Spine Health of Surgeons
A study testing Neck strengthening exercise program in people with Occupational Health Physicians and Neck Pain, run by University of British Columbia at 1 site in Canada.
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. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Occupational Health Physicians, Neck Pain
- What is being tested?
- Neck strengthening exercise program
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2015to Sep 2016
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- All first year general surgery residents at the University of British Columbia
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Occupational Health Physicians, Neck Pain
- Being tested
- Neck strengthening exercise program
- Keywords
- Surgeon neck health
- Medical subject headings
- Neck Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neck strengthening exercise programProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| PGY1 General Surgery Residents | Experimental | All first year general surgery residents at the University of British Columbia Receives: Procedure: Neck strengthening exercise program |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 10 weeks
Secondary outcomes (1)
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.
Measured: 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2013 (estimated)
- Study startDec 2015
- Primary completionJun 2016 (estimated)
- Study completionSep 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Occupational Health PhysiciansStudies of the same condition, open and under way.
- More trials run by University of British ColumbiaThe 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of British Columbia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- York NH Hsiang, MB MHSc FRCSC, Principal investigator, Professor of Surgery, Division of Vascular Surgery, Department of Surgery
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01932307
- Sponsor's protocol ID
- H13-01151
- Status last verified
- Sep 2015
- First submitted
- 27 Aug 2013
- Last updated
- 1 Oct 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Oct 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cervical Spine Health of Surgeons
- ClinicalTrials.gov ID
- NCT01932307
- Acronym / sponsor ID
- H13-01151
- Conditions
- Occupational Health Physicians, Neck Pain
- Keywords
- Surgeon neck health
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of British ColumbiaUniversity, hospital or other
- Study start
- Dec 2015
- Primary completion
- Jun 2016 (estimated)
- Study completion
- Sep 2016 (estimated)
- First posted
- 30 Aug 2013 (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.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PGY1 General Surgery Residents | Experimental | Procedure: Neck strengthening exercise programAll first year general surgery residents at the University of British Columbia |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- All first year general surgery residents at the University of British Columbia
Key exclusion criteria (7 listed)
- Previous serious neck injury (e.g. herniated disc)
- Chest pain during physical exercise
- Heart failure
- Spinal Stenosis
- Radicular nerve pain
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 |
|---|---|---|
| Neck strengthening exercise programStudy 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. | Procedure or surgery | PGY1 General Surgery Residents |
Primary outcome
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.
1 secondary outcome
Adherence and attitudes towards the exercise program
Time frame: 10 weeks
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2015.
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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.
York NH Hsiang, MB MHSc FRCSC principal investigator
Professor of Surgery, Division of Vascular Surgery, Department of Surgery
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neck strengthening exercise program in people with Occupational Health Physicians and Neck Pain, run by University of British Columbia at 1 site in Canada.
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 7 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: withdrawn, as of the sponsor's last update on 1 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neck pain and quality of life questionnaires (time frame: 10 weeks). 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 1 Oct 2015.