- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01932307
Cervical Spine Health of Surgeons
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Descrizione dettagliata
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.
Tipo di studio
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
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British Columbia
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Vancouver, British Columbia, Canada, V5Z 1M9
- Vancouver General Hospital
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
- Bambino
- Adulto
- Adulto più anziano
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Prevenzione
- Assegnazione: N / A
- Modello interventistico: Assegnazione di gruppo singolo
- Mascheramento: Nessuno (etichetta aperta)
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
|---|---|
|
Sperimentale: 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.
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Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Neck pain and quality of life questionnaires
Lasso di tempo: 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.
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10 weeks
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Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
|---|---|---|
|
Adherence and attitudes towards the exercise program
Lasso di tempo: 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.
|
10 weeks
|
Collaboratori e investigatori
Sponsor
Investigatori
- Investigatore principale: York NH Hsiang, MB MHSc FRCSC, Professor of Surgery, Division of Vascular Surgery, Department of Surgery
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Anticipato)
Completamento dello studio (Anticipato)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- H13-01151
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
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