- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01932307
Cervical Spine Health of Surgeons
Studie Overzicht
Toestand
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Preventie
- Toewijzing: NVT
- Interventioneel model: Opdracht voor een enkele groep
- Masker: Geen (open label)
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: PGY1 General Surgery Residents
All first year general surgery residents at the University of British Columbia
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Neck pain and quality of life questionnaires
Tijdsspanne: 10 weeks
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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.
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10 weeks
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Adherence and attitudes towards the exercise program
Tijdsspanne: 10 weeks
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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.
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10 weeks
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: York NH Hsiang, MB MHSc FRCSC, Professor of Surgery, Division of Vascular Surgery, Department of Surgery
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Verwacht)
Studie voltooiing (Verwacht)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- H13-01151
Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .
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