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Testing the Feasibility of Intervening to Optimize Chiropractic Care for Adults With Neck Pain Disorders

12 settembre 2016 aggiornato da: Dr. Andre Bussieres, McGill University

Chiropractors Can Do: Testing the Feasibility of Intervening to Optimize Chiropractic Care for Adults With Neck Pain Disorders: A Pilot Cluster Randomized Controlled Trial

To assess the feasibility of conducting a larger cluster randomized controlled trial to facilitate the effectiveness of a complex Knowledge Translation (KT) intervention, i.e. implementation of multimodal care, into chiropractic clinical practice, designed to improve the management of patients with Non-Specific Neck Pain (NSNP) disorders.

To evaluate feasibility, the investigators will ascertain how well participating chiropractors and patients adhere to the study protocol and will solicit feedback from them about the overall usefulness of the content and format of the KT intervention. This study will determine planning for the main study and also the outcomes to be used as a primary outcome.

Panoramica dello studio

Stato

Completato

Condizioni

Intervento / Trattamento

Descrizione dettagliata

The aim of this pilot study project is to determine the feasibility of implementing a multifaceted KT intervention to promote the use of multimodal care by chiropractors managing patients with NSNP.

Design: Cluster randomized controlled pilot and feasibility trial. Chiropractors in private practice in Canada will be randomized to receive either a theory-based tailored KT intervention in the experimental group or simply a printed copy of the guideline in the control group.

Study population and sample size: 30 chiropractors will be recruited from a random, nationally representative sample of 200 chiropractors. Each chiropractor will recruit five neck pain patients for a total of 150 patients.

The design of the KT intervention was informed by the results of a related qualitative study (Theoretical Domains Framework interviews) and consists of a series of three webinars, two online case scenarios, a self-management video on Brief Action Planning (BAP) and a printed copy of the practice guideline (Bussières et al., 2015).

Primary feasibility outcomes for both chiropractors and patients include rates of: 1) recruitment, 2) study retention, and 3) adherence to the intervention (Tickle-Degnen, 2013). A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations e.g., exercise and self-care prescriptions, at study onset and at three months follow-up.

Secondary outcomes include whether or not the chiropractor's recommended multimodal care, scores on measures of behavioural constructs e.g., self-efficacy, knowledge.

Primary clinical outcomes for patients includes measures of pain intensity and neck pain-specific disability.

Analyses from this pilot study will focus on generating point estimates and corresponding 95% confidence intervals for parameters of a priori interest (e.g., recruitment, retention, adherence, pain intensity, neck disability index).

Discussion: The main strength of this study includes its use of a representative sample and randomized controlled design. The results of this study will inform the design of a larger cluster randomized controlled trial aimed at confirming the effectiveness and increasing the use of multimodal care by chiropractors managing patients with NSNP.

Tipo di studio

Interventistico

Iscrizione (Effettivo)

32

Fase

  • Fase 1

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1Y5
        • McGill University

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

Da 18 anni a 65 anni (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Chiropractors

Inclusion criteria:

  • Registered with their professional licensing boards and in private practice in the Canada;
  • Graduated at least one year ago;
  • Provide chiropractic treatment to a minimum of two adults (age 18-65) with neck pain per week;
  • Speak English or French; and
  • Have access to Internet.

Exclusion criteria:

  • Chiropractors will be excluded if they have already attended the webinar series or the self-management learning module. Prior webinar and learning module participants will have needed to register beforehand, which therefore provides the mechanism for confirming study ineligibility.

Patients

Inclusion criteria:

  • Attend a consenting chiropractor for non-specific neck pain of any duration;
  • Aged between 18 and 65, with a primary complaint of acute (<3 months) or chronic (>3 months) neck pain presenting as a new condition for treatment at the participating clinic;
  • Fluency in English or French to a level where they can read and understand the study information sheet, complete the consent form, and respond to the telephone-administered questionnaire. This will be assessed by the staff member of each chiropractor's team at the time of screening; and
  • Provide written informed consent.

Exclusion criteria:

  • Previous neck surgery;
  • Presence of Red flags;
  • Pregnancy; and
  • Chiropractic care received in the preceding 3 months for a complaint of neck pain

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Ricerca sui servizi sanitari
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Triplicare

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Multifaceted KT intervention
Webinars, online vignettes and e-module, copy of guideline recommendations
Comportamentale: Multifaceted KT intervention

The intervention consists of three webinars followed by the quiz, two online case scenario and a video on BAP model plus a printed copy of Clinical Practice Guideline (CPGs) on NSNP.

After completing these modules and learning the key strategies, each chiropractor will recruit five neck pain patients and implement the strategies on their patients to measure the clinical outcomes for a follow-up of three months.

The control group will receive only a printed copy of CPGs. A checklist of proxy measures embedded within patient encounter forms will be used to assess chiropractors' compliance with guideline recommendations at study onset and at three months.
Nessun intervento: Control
Printed copy of guideline recommendations

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Feasibility outcome (composite outcome measure)
Lasso di tempo: 6 months

The main outcome of interest is feasibility that includes recruitment, retention, adherence to the study protocol and effectiveness potential.

Recruitment rate include: 1) eligibility rate (number of eligible chiropractors and patients divided by invited chiropractors or patients) and 2) participation rate (number agreeing to participate divided by eligible chiropractors or patients).

Retention rate: Number of chiropractors and patients who completed all outcome measures at baseline and at 3 month follow-up plus rate of completion of questionnaires by chiropractors (measures of behavioural constructs) and patients (clinical outcomes).

For chiropractors, rate of adherence includes attendance of all 3 webinars, associated quizzes, 2 clinical vignettes and the self-management learning module; For patients, rate of adherence includes follow-up visits, prescribed home exercise and physical activity.
6 months

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Scores on measures of behavioural constructs (composite outcome measure)
Lasso di tempo: 6 months
For chiropractors: Scores on measures of behavioural constructs (levels of knowledge and self-efficacy) for recommended multimodal care.
6 months

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Pain
Lasso di tempo: 3 months (before and at the end of treatment)
Self-rated level of pain on an 11 points continuous Visual Analogue Scale (VAS)
3 months (before and at the end of treatment)
Disability
Lasso di tempo: 3 months (before and at the end of treatment)
Self-rated disability due to neck pain measured on the Neck Disability Index (NDI). Scale range and subscales:10 items in total, each item is scored from 0-5 ("0" = no disability and "5" = full disability) for a total of 50
3 months (before and at the end of treatment)
Satisfaction with care
Lasso di tempo: 3 months (end of treatment) and 3 months of follow-up
Self-rated satisfaction with care measured on the Short Form Patient Satisfaction Questionnaire (PSQ-18). Scale range and subscales:10 items in total, each item is scored from 1-5 ("1" = strongly agree and "5" = strongly disagree)
3 months (end of treatment) and 3 months of follow-up

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

McGill University

Investigatori

  • Investigatore principale: André E Bussières, PhD, McGill University

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio

1 giugno 2015

Completamento primario (Effettivo)

1 marzo 2016

Completamento dello studio (Effettivo)

1 maggio 2016

Date di iscrizione allo studio

Primo inviato

17 giugno 2015

Primo inviato che soddisfa i criteri di controllo qualità

24 giugno 2015

Primo Inserito (Stima)

26 giugno 2015

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Stima)

14 settembre 2016

Ultimo aggiornamento inviato che soddisfa i criteri QC

12 settembre 2016

Ultimo verificato

1 settembre 2016

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • G241013 R.E Strauss X-C 218563

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

Indeciso

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

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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