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

12 septembre 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

32

Phase

  • La phase 1

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

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

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Recherche sur les services de santé
  • Répartition: Randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Tripler

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Multifaceted KT intervention
Webinars, online vignettes and e-module, copy of guideline recommendations
Comportemental: 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.
Aucune intervention: Control
Printed copy of guideline recommendations

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Feasibility outcome (composite outcome measure)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Scores on measures of behavioural constructs (composite outcome measure)
Délai: 6 months
For chiropractors: Scores on measures of behavioural constructs (levels of knowledge and self-efficacy) for recommended multimodal care.
6 months

Autres mesures de résultats

Mesure des résultats
Description de la mesure
Délai
Pain
Délai: 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
Délai: 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
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

McGill University

Les enquêteurs

  • Chercheur principal: André E Bussières, PhD, McGill University

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 juin 2015

Achèvement primaire (Réel)

1 mars 2016

Achèvement de l'étude (Réel)

1 mai 2016

Dates d'inscription aux études

Première soumission

17 juin 2015

Première soumission répondant aux critères de contrôle qualité

24 juin 2015

Première publication (Estimation)

26 juin 2015

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

14 septembre 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

12 septembre 2016

Dernière vérification

1 septembre 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • G241013 R.E Strauss X-C 218563

Plan pour les données individuelles des participants (IPD)

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Indécis

Informations sur les médicaments et les dispositifs, documents d'étude

Étudie un produit pharmaceutique réglementé par la FDA américaine

Non

Étudie un produit d'appareil réglementé par la FDA américaine

Non

produit fabriqué et exporté des États-Unis.

Non

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