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Long-term Multidisciplinary Team-based Management of Back Pain (TeamBack)

22 de abril de 2022 actualizado por: Spine Centre of Southern Denmark

Long-term Multidisciplinary Team-based Management of Back Pain: Development and Feasibility (TeamBack Trial)

Long-term approaches are challenging to implement within the current care system, which rewards clinicians for attempting to quick-fix a long-term condition. This results in increased inappropriate imaging, opioid prescriptions, surgery, and visits/rehabilitation in secondary care, leading to higher societal costs and the continuing increase of LBP-related disability that is currently observed.

The investigators argue that LBP management can be optimized by providing patients with self-management strategies supported by a multidisciplinary team and providing simple, safe, and low-cost interventions that adhere to clinical guidelines. This has the potential to change patient behaviors and facilitate empowerment to self-manage LBP leading to lower societal costs of LBP.

Research objectives

The investigators will develop and test a long-term supportive multidisciplinary team-based management strategy with a specific focus on communicating a structured and unchanging message about individualized diagnosis, treatment, and prognosis, focusing on conducting a large randomized controlled trial as the next phase.

This feasibility trial will be completed in a secondary care settings, where relevant patients with poor management skills and insufficient effects of usual (primary) care management can be identified.

The specific objectives are:

(I) To develop a long-term supportive multidisciplinary team-based management strategy for secondary-care low back pain patients

(II) To test the feasibility by assessing:

  • Changes in relevant outcomes
  • Utilization of Primary care
  • Patients and clinicians experience with the intervention
  • Practical challenges of the setting

The management strategy development follows the principles provided by the Medical Research Council for developing complex interventions.

Development of the framework

Step 1: Framework setup

The investigators constructed a basic framework for the intervention by reviewing relevant systematic reviews and clinical guidelines. The research group determined the initial management intervention. Afterward, the investigators conducted a small survey on 191 participants (11% of the total sample of patients between February and May 2021), about their interest in participating. The majority would find such an approach of interest (147(77%)). In parallel, the investigators conducted short semi-structured interviews concerning the intervention with a convenient sample of 20 patients. Seventeen provided usable data.

Step 2 - Development

Using the participants' information, the investigators re-framed the management strategy. Subsequent semi-structured focus-group interviews with a clinical panel for further modifications before testing was conducted.

Step 3 - Feasibility

The multidisciplinary team for the feasibility trial consists of two coordinators (chiropractors), two therapists (physical therapists), one medical doctor, and one nurse.

The feasibility trial aims to identify and develop the appropriate framework by:

I) Investigating the patients' experiences of the current management strategy II) Ensuring satisfactory work-relations between clinicians III) Determining the primary outcome IV) Mapping the multiple interacting components of the management strategy V) Investigating how to measure parallel use of primary care and how this could be applied in the trial evaluation VI) Estimating the workload (number of hours) of the clinicians VII) Quantifying any out-of-protocol behaviors by clinicians and patients alike VIII) Quantifying the different aspects of the intervention using the clinical records

The feasibility trial will include 25 LBP patients from the Spine Centre willing to participate in a limited three-month follow-up.

The intervention procedure is:

1) A team meeting will be held each morning where the coordinator and the feasibility team will go through the patients. This will start the initial sparring process to ensure a structured and unchanging message for the patient.

The coordinator will first assess each patient face-to-face according to ICD-10 principles and enroll eligible patients in the trial. Afterward, the therapist will evaluate the patient's current functional status and management strategy. During the three months, patients will have multiple encounters with the coordinator, the therapist, and the nurse, if needed. The therapist will provide further interventions (e.g., exercise and cognitive/behavioral therapy) to encourage self-management.

The investigators will assess the following outcomes at three months: Disability (primary), pain, self-efficacy, quality of life, LBP trajectory, workability, and work retention.

Descripción general del estudio

Estado

Terminado

Condiciones

Tipo de estudio

Intervencionista

Inscripción (Actual)

24

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

      • Middelfart, Dinamarca, 5500
        • Spine Centre of Southern Denmark

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 y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

  • Able to speak Danish
  • Disability score > 40%
  • Duration of current episode > 3 months

Exclusion Criteria:

  • Surgical candidate due to acute radiculopathy
  • Malignant or inflammatory back pain

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: N / A
  • Modelo Intervencionista: Asignación de un solo grupo
  • Enmascaramiento: Ninguno (etiqueta abierta)

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Multidisciplinary
A pragmatic team-based management approach is individualized for each patient.
The team will educate the patient about low back pain and how this can be self-managed.
Otros nombres:
  • Long-term team-based support
The team will advice the patient to conduct relevant exercises and to stay physical active.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Disability
Periodo de tiempo: Changes in mean values from baseline to 3 months
The Oswestry disability index
Changes in mean values from baseline to 3 months

Colaboradores e Investigadores

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

Investigadores

  • Investigador principal: Casper G Nim, PhD, Spine Center of Southern Denmark, University Hospital of Southern Denmark

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)

10 de noviembre de 2021

Finalización primaria (Actual)

20 de abril de 2022

Finalización del estudio (Actual)

20 de abril de 2022

Fechas de registro del estudio

Enviado por primera vez

13 de octubre de 2021

Primero enviado que cumplió con los criterios de control de calidad

29 de octubre de 2021

Publicado por primera vez (Actual)

10 de noviembre de 2021

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

25 de abril de 2022

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

22 de abril de 2022

Última verificación

1 de abril de 2022

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • TeamBack

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

No

Descripción del plan IPD

We have no plans of sharing the individual participant data, as there is no available data for secondary analyses.

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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