- ICH GCP
- US Clinical Trials Registry
- Klinisk utprøving NCT01932307
Cervical Spine Health of Surgeons
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
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
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
-
-
British Columbia
-
Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
-
-
Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Forebygging
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Ingen (Open Label)
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: 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.
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Neck pain and quality of life questionnaires
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Adherence and attitudes towards the exercise program
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Sponsor
Etterforskere
- Hovedetterforsker: York NH Hsiang, MB MHSc FRCSC, Professor of Surgery, Division of Vascular Surgery, Department of Surgery
Studierekorddatoer
Studer hoveddatoer
Studiestart
Primær fullføring (Forventet)
Studiet fullført (Forventet)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Anslag)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- H13-01151
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