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Implementation of a Behavioural Medicine Approach in Physical Therapy for Treatment of Chronic Pain

15 novembre 2019 mis à jour par: Mälardalen University

A Behavioural Medicine Approach in Physical Therapy for Treatment of Chronic Pain - Evaluation of the Implementation Process and Outcome

Implementation of a behavioral medicine (BM) approach in physical therapy (PT) for patients with persistent musculoskeletal pain is in accordance with the state of science. Translation of research into clinical PT practice is challenging and may demand active implementation strategies.

The aim is to evaluate the implementation of a behavioural medicine approach for patients with persistent musculoskeletal pain concerning sustainable health benefits and sick-leave, as well as the cost-effectiveness of the implemented treatment.

Treatment outcomes for patients from two groups of physical therapists in primary care will be compared. In one group active implementation strategies have been employed, and in the other (control) passive implementation strategies during a 6-months intervention period. Patients are recruited during one-year after the implementation period.

The short and long-term effects of the implementation of the BM approach in PT treatment on patients' sick-leave, activity and participation, and health related quality of life will be compared to the patients from control condition clinics. The cost-effect and cost-benefit of an implementation of a behavioral medicine approach in physical therapy is evaluated from the perspective of the health care organization and society.

Aperçu de l'étude

Statut

Inconnue

Les conditions

Intervention / Traitement

Description détaillée

The aim is to investigate the short and long-term effects for the implementation of a behavioral medicine approach in physical therapy on patients' sick-leave, activity and participation, and health related quality of life, compared to the control condition. Further the aim is to evaluate the cost-effect and cost-benefit of an active implementation of a behavioural medicine approach in physical therapy, compared to the passive implementation in the control condition.

In total 109 primary care patients with musculoskeletal pain ≥ 4 weeks are included consecutively in the active implementation and passive implementation (control) clinics. The sample size was based on a priori power analysis on differences in primary outcome between conditions and expected attrition. Patients from both conditions are included during the first year after the implementation period.

Data collection has been at onset and end of patients' treatment period, and will be at 6, 12, and 18 months post treatment (in both implementation and control clinics).

Recommended core outcomes regarding body structure, activity and participation are used. Primary outcomes: Participation in work life defined as days of sick-leave and participation in everyday life. Secondary outcomes will be patients' ratings of global treatment effects and pain intensity. Process measures: prognostic psychosocial factors possible to address in physical therapy such as functional self-efficacy, fear of movement and patient expectations on treatment effects. Depression, seen as a confounder, will be controlled for. Calculation of costs will include avoidable cost of the implementation, sunk costs will be ignored. Direct health care costs, i.e. use of health care services will be identified, measured and priced to assess costs from a societal perspective. Indirect costs, i.e. production loss due to sick leave and health care visits will be estimated. Cost-benefit will be calculated from the perspective of the society. Economic benefits will be measured as the net value of production gained for society, with an appropriate discount rate. Costs for society will be calculated on direct health care costs.

Data analyses: Regression models are used to compare patient outcomes between implementation and control clinics and performed per protocol and on an intention-to-treat-basis. Total costs, i.e. direct health care costs, direct and indirect non-health care costs and incremental costs, will be compared between conditions. A ratio between difference in outcome scores and costs between baseline and 6, 12, and 18 months post treatment will be. Incremental costs will be calculated per cost-benefit ratio associated with treatments in the two conditions. Bootstrapping is used for confidence intervals for cost-effectiveness and cost-benefit ratios.

Type d'étude

Interventionnel

Inscription (Réel)

109

Phase

  • N'est pas applicable

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

  • Suède
      • Gavle, Suède
        • Region Gävleborg
      • Nykoping, Suède, SE-61188
        • Landstinget Sörmland
      • Vasteras, Suède, SE-72189
        • Region Västmanland

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

Inclusion criteria:

  • Patients who presents for physical therapy in primary care.
  • 18 - 65 years of age
  • musculoskeletal pain for 4 weeks or more
  • ability to speak and understand spoken and written Swedish

Exclusion criteria:

  • systemic disease
  • malignity
  • serious spinal pathology
  • osteoarthritis waiting for surgery
  • diagnosed depression
  • neurological disease or injury that severely affect activity capacity

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: Traitement
  • Répartition: Non randomisé
  • Modèle interventionnel: Affectation parallèle
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Expérimental: Active implementation clinics
Patients recruited by physical therapists who underwent an implementation period with active implementations strategies, such as supervision, web lectures, peer learning in groups consisting of colleagues. A behavioral medicine approach in physical therapy for patients with musculoskeletal pain was encouraged with these active implementation strategies.
Comportemental: Active implementation clinics
Physical therapy treatment as the physical therapist chooses
Comparateur actif: Passive implementation clinics
Patients recruited by physical therapists who underwent an implementation period with passive implementations strategies, such as written material and a short web lecture. A behavioral medicine approach in physical therapy for patients with musculoskeletal pain was encouraged with these passive implementation strategies
Comportemental: Passive implementation clinics
Physical therapy treatment as the physical therapist chooses

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Change in days of sick-leave
Délai: through study completion, an average of 1 year
Self-reports and sick-leave data from the Swedish Social Insurance Administration
through study completion, an average of 1 year
Change in pain-related disability using Pain Disability Index
Délai: through study completion, an average of 1 year
Pain Disability Index: Measure of disruptions in seven dimensions of everyday life. Self-reports on a11-graded numerical rating scale
through study completion, an average of 1 year
Change in health related quality of life using EQ-5D
Délai: through study completion, an average of 1 year
EuroQol, Quality of life scale in 5 dimensions (EQ-5D) which provides a simple descriptive profile and a single index value for health status.
through study completion, an average of 1 year

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Change in the patients' perceptions of global treatment effect Change in perceived global treatment effect using the Patient Global Impression of Change Scale
Délai: through study completion, an average of 1 year
Patients Global Impression of Change (PGIC) scale which provides the patient's belief about the treatment effect rated on a 7-graded scale
through study completion, an average of 1 year
Change in self-efficacy for daily activities using the Self-efficacy Scale
Délai: through study completion, an average of 1 year
The Self-efficacy Scale: ratings of self-efficacy for 20 common activities in daily life
through study completion, an average of 1 year
Change in catastrophizing thoughts about pain using the Catastrophizing subscale of the Coping Strategies Questionnaire
Délai: through study completion, an average of 1 year
The Catastrophizing subscale of the Coping Strategies Questionnaire: ratings of pain-related catastrophizing thoughts
through study completion, an average of 1 year
Change in fear of movement/(re)injury using the Tampa Scale of Kinesiophobia
Délai: through study completion, an average of 1 year
The Tampa Scale of Kinesiophobia: ratings of fear and avoidance of movement
through study completion, an average of 1 year

Collaborateurs et enquêteurs

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

Parrainer

Mälardalen University

Les enquêteurs

  • Chercheur principal: Anne Söderlund, professor, Mälardalen University, Box 883, SE-721 23 Västerås, Sweden

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 novembre 2016

Achèvement primaire (Anticipé)

1 septembre 2022

Achèvement de l'étude (Anticipé)

1 novembre 2022

Dates d'inscription aux études

Première soumission

20 mars 2017

Première soumission répondant aux critères de contrôle qualité

13 avril 2017

Première publication (Réel)

18 avril 2017

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Réel)

18 novembre 2019

Dernière mise à jour soumise répondant aux critères de contrôle qualité

15 novembre 2019

Dernière vérification

1 novembre 2019

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • 140369

Plan pour les données individuelles des participants (IPD)

Prévoyez-vous de partager les données individuelles des participants (DPI) ?

NON

Description du régime IPD

No plan to share individual participant data (IPD) because the participants have been assured of confidentiality and that only the researchers in the Project will have access to IPD

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

Ces informations ont été extraites directement du site Web clinicaltrials.gov sans aucune modification. Si vous avez des demandes de modification, de suppression ou de mise à jour des détails de votre étude, veuillez contacter register@clinicaltrials.gov. Dès qu'un changement est mis en œuvre sur clinicaltrials.gov, il sera également mis à jour automatiquement sur notre site Web .

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