PT-IN-MIND: study protocol for a multisite randomised feasibility trial investigating physical therapy with integrated mindfulness (PT-IN-MIND) for patients with chronic musculoskeletal pain and long-term opioid treatment who attend outpatient physical therapy.
BMJ Open
; 14(7): e082611, 2024 Jul 30.
Article
em En
| MEDLINE
| ID: mdl-39079926
ABSTRACT
INTRODUCTION:
Many individuals receiving outpatient physical therapy have musculoskeletal pain and up to one-third use prescription opioids. The impact of physical therapist-led mindfulness-based interventions integrated with evidence-based physical therapy (I-EPT) to manage patients with chronic musculoskeletal pain and long-term opioid treatment has not been elucidated. This project evaluates the feasibility of conducting a cluster randomised trial to test the effectiveness of I-EPT. METHODS ANDANALYSIS:
Study 1aim:
Refine and manualise the I-EPT treatment protocol. Our approach will use semistructured interviews of patients and physical therapists to refine an I-EPT training manual. Study 2aim:
Evaluate different intensities of physical therapist training programmes for the refined I-EPT treatment protocol. Physical therapists will be randomised 111 to high-intensity training (HighIT), low-IT (LowIT) training and no training arms. Following training, competency in the provision of I-EPT (LowIT and HighIT groups) will be assessed using standardised patient simulations. Study 3aim:
Evaluate the feasibility of the I-EPT intervention across domains of the Reach, Effectiveness, Adoption, Implementation, Maintenance implementation framework. The refined I-EPT treatment protocol will be tested in two different health systems with 90 patients managed by the randomised physical therapists. The coprimary endpoints for study 3 are the proportions of the Pain, Enjoyment of Life and General Activity Scale and the Timeline Followback for opioid use/dose collected at 12 weeks. ETHICS AND DISSEMINATION Ethics approval for the study was obtained from the University of Utah, University of Florida and Florida State University Institutional Review Boards. Informed consent is required for participant enrolment in all phases of this project. On completion, study data will be made available in compliance with NIH data sharing policies. TRIAL REGISTRATION NUMBER NCT05875207.Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Estudos de Viabilidade
/
Modalidades de Fisioterapia
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Dor Musculoesquelética
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Dor Crônica
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Atenção Plena
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Analgésicos Opioides
Limite:
Humans
Idioma:
En
Revista:
BMJ Open
Ano de publicação:
2024
Tipo de documento:
Article
País de afiliação:
Estados Unidos
País de publicação:
Reino Unido