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PNE Effectiveness Cluster Trial (PNE)

28 de julio de 2020 actualizado por: Elizabeth Lane, University of Utah

The Effectiveness of Training Physical Therapists in Pain Neuroscience Education on Patient Reported Outcomes for Patients With Chronic Spinal Pain

This is a cluster randomized trial that involves training regions of physical therapy clinics to use pain neuroscience education or continue with usual care. The investigators will examine outcomes for patients with chronic neck or back pain.

Descripción general del estudio

Estado

Terminado

Descripción detallada

Chronic spinal pain is a very common and costly condition. An estimated 26.4% of Americans have experienced an episode low back pain (LBP) and 13.8% have experienced neck pain in the past 3 months. Lifetime prevalence of spinal pain ranges from 54% to 80% and the estimated healthcare costs for those with spinal pain are 57% higher than those without. While many with acute LBP have a favorable prognosis, those who develop chronic pain continue will experience persistent poor health and place a large burden on the healthcare system.

With growing healthcare costs and mounting disability, there is increased demand for physical therapists to promote more effective self-management strategies for patients with chronic spinal pain. Education is a critical component of self-management. Pain neuroscience education (PNE) is an education method used by physical therapists to help patients understand the biology, physiology and psychological factors influencing their pain experience and to reconcile faulty cognitions and beliefs associated with persistent pain and disability8. PNE has been shown to have positive effects on patient-reported outcomes for a variety of spinal pain conditions. This study will examine the impact of widespread implementation of PNE into routine physical therapy care.

The proposed mechanism of PNE is proposed to relate changes in patients' conceptualization of the pain experience, specifically concepts associated with fear, knowledge, and beliefs of pain. Additional research has identified autonomous motivation and self-efficacy as relevant to patients' behavioral responses to pain. Autonomous motivation is proposed to be an essential factor for behavior change, adhering to a treatment program and persistent positive health behavior changes. Autonomous motivation has not been examined as an influencing factor in the PNE model. Self-efficacy relates to the degree an individual feels they have control over their situation; and high self-efficacy has been associated with more active coping efforts. This study will examine self-efficacy and autonomous motivation as potential mediators of the ability of a PNE intervention improve functional outcomes in a pragmatic clinical environment.

This project's overall goal is to determine the effectiveness of providing physical therapists with PNE training on patient-centered outcomes (physical function and pain interference) for patients with chronic neck or back pain receiving physical therapy. Secondarily, the investigators will explore mechanisms of effects of PNE by examining the role of autonomous motivation and self-efficacy. To accomplish these goals, the investigators will conduct a cluster-randomized clinical trial, randomly assigning groups of clinics to receive PNE training or usual care with no additional training for physical therapists working in the clinic. This design allows for maximum external validity and generalizability across outpatient physical therapy clinics.

Primary Aims I. Compare effectiveness of PNE training vs. no additional training for physical therapists on patient-centered outcomes (physical function and pain interference) for patients with chronic spinal pain. The investigators hypothesize patients receiving treatment from physical therapists receiving PNE education will show greater improvement in patient-centered outcomes.

Secondary Aims I. Compare the effects of PNE training vs. no additional training for physical therapists on the patient-physical therapist alliance. The investigators hypothesize patients receiving treatment from physical therapists receiving PNE education will show greater alliance with their physical therapist.

II. Explore the mediating effects of autonomous motivation and self-efficacy on patient-centered outcomes. The investigators hypothesize autonomous motivation and/or self-efficacy will mediate the effects of education on patient-centered outcomes.

Tipo de estudio

Intervencionista

Inscripción (Actual)

316

Fase

  • No aplica

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

    • Alabama
      • Birmingham, Alabama, Estados Unidos, 35242-8601
        • BenchMark
      • Birmingham, Alabama, Estados Unidos, 35243-2366
        • BenchMark
      • Helena, Alabama, Estados Unidos, 35080-3773
        • BenchMark
      • Hoover, Alabama, Estados Unidos, 35244-1254
        • BenchMark
      • Moody, Alabama, Estados Unidos, 35004-3101
        • BenchMark
      • Phenix City, Alabama, Estados Unidos, 36867-7484
        • BenchMark
    • Georgia
      • Acworth, Georgia, Estados Unidos, 30101-8352
        • Benchmark Physical Therapy
      • Alpharetta, Georgia, Estados Unidos, 30005-4202
        • BenchMark
      • Atlanta, Georgia, Estados Unidos, 30306-4530
        • BenchMark
      • Atlanta, Georgia, Estados Unidos, 30308-1245
        • BenchMark
      • Atlanta, Georgia, Estados Unidos, 30316-6833
        • BenchMark
      • Atlanta, Georgia, Estados Unidos, 30318-3117
        • BenchMark
      • Atlanta, Georgia, Estados Unidos, 30319
        • BenchMark
      • Atlanta, Georgia, Estados Unidos, 30342-1461
        • BenchMark
      • Austell, Georgia, Estados Unidos, 30106-8531
        • BenchMark
      • Canton, Georgia, Estados Unidos, 30114-5603
        • BenchMark
      • Canton, Georgia, Estados Unidos, 30115-9376
        • BenchMark
      • Carrollton, Georgia, Estados Unidos, 30117-4456
        • BenchMark
      • Cartersville, Georgia, Estados Unidos, 30121-3305
        • BenchMark
      • Columbus, Georgia, Estados Unidos, 31909-5649
        • BenchMark
      • Dallas, Georgia, Estados Unidos, 30157-4702
        • BenchMark
      • Decatur, Georgia, Estados Unidos, 30033-5305
        • BenchMark
      • Dunwoody, Georgia, Estados Unidos, 30338-4163
        • BenchMark
      • Hiram, Georgia, Estados Unidos, 30141-2692
        • BenchMark
      • Jasper, Georgia, Estados Unidos, 30143-8704
        • BenchMark
      • Kennesaw, Georgia, Estados Unidos, 30144-3210
        • BenchMark
      • Lawrenceville, Georgia, Estados Unidos, 30046-8767
        • Rehab South
      • Marietta, Georgia, Estados Unidos, 30060-9412
        • BenchMark
      • Marietta, Georgia, Estados Unidos, 30062-4197
        • BenchMark
      • Marietta, Georgia, Estados Unidos, 30064-5037
        • BenchMark
      • Marietta, Georgia, Estados Unidos, 30067-8642
        • BenchMark
      • Marietta, Georgia, Estados Unidos, 30068-5418
        • BenchMark
      • Newnan, Georgia, Estados Unidos, 30265-6506
        • Rehab South
      • Peachtree City, Georgia, Estados Unidos, 30269-1571
        • Rehab South
      • Peachtree City, Georgia, Estados Unidos, 30269
        • BenchMark
      • Roswell, Georgia, Estados Unidos, 30075-7524
        • BenchMark
      • Roswell, Georgia, Estados Unidos, 30076-0929
        • BenchMark
      • Roswell, Georgia, Estados Unidos, 30076-3866
        • BenchMark
      • Smyrna, Georgia, Estados Unidos, 30080-9213
        • BenchMark
      • Suwanee, Georgia, Estados Unidos, 30024-9104
        • BenchMark
      • Tucker, Georgia, Estados Unidos, 30084-4916
        • BenchMark

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años a 75 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Age 18-75 at time of first physical therapy session
  • Primary reason for physical therapy is low back and/or neck pain
  • Meets the NIH definition of chronic pain (i.e., neck or back pain on at least half the days in the past 6 months.)

Exclusion Criteria:

  • No spinal surgery within the previous 12 months
  • No evidence of "red flag" conditions (e.g., cauda equine syndrome, cancer, fracture, infection or systemic disease) that requires immediate referral from physical therapy to medical care
  • Not currently known to be pregnant

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Sin intervención: Usual Care
Usual care, no intervention
Experimental: Pain Neuroscience Education Training
The region of clinics randomized to this arm will receive PNE education, which consists of 6 weeks online training followed by an on-site training day.
PNE training will consist of 6 weeks online training followed by one day training session.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient-Reported Outcomes Measurement Information System (PROMIS) Physical Function
Periodo de tiempo: 2 week and 12 week
Change score of Physical Function scores from baseline
2 week and 12 week

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Patient-Reported Outcomes Measurement Information System (PROMIS) Pain Interference
Periodo de tiempo: 2 week and 12 week
Change score of Pain Interference scores from baseline
2 week and 12 week
pain self-efficacy
Periodo de tiempo: 2 week and 12 week
Measured by Pain Self-Efficacy Questionnaire
2 week and 12 week
Autonomous motivation
Periodo de tiempo: 2 week and 12 week
Measured by Treatment Self-regulation Questionnaire
2 week and 12 week
Therapeutic Alliance
Periodo de tiempo: 2 week and 12 week
As measured by Working Alliance Theory of Change Inventory
2 week and 12 week

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Publicaciones y enlaces útiles

La persona responsable de ingresar información sobre el estudio proporciona voluntariamente estas publicaciones. Estos pueden ser sobre cualquier cosa relacionada con el estudio.

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

24 de mayo de 2017

Finalización primaria (Actual)

1 de junio de 2019

Finalización del estudio (Actual)

1 de junio de 2019

Fechas de registro del estudio

Enviado por primera vez

23 de mayo de 2017

Primero enviado que cumplió con los criterios de control de calidad

24 de mayo de 2017

Publicado por primera vez (Actual)

30 de mayo de 2017

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

29 de julio de 2020

Última actualización enviada que cumplió con los criterios de control de calidad

28 de julio de 2020

Última verificación

1 de julio de 2020

Más información

Términos relacionados con este estudio

Otros números de identificación del estudio

  • 00097154

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

NO

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

No

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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