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Effect of Reassuring Information on Danish Workers Who Experience Low Back Pain in the Following Year. (VRRPF)

22 de agosto de 2017 actualizado por: Pernille Frederiksen, Glostrup University Hospital, Copenhagen

Effect of an Educational Based Intervention on Danish Workers With Low Back Pain. A Randomized Controlled Single Blinded Study.

RCT study of the effect of an educational-based intervention on low back pain-related outcomes concerning beliefs and behaviour.

Descripción general del estudio

Estado

Terminado

Descripción detallada

Previous studies have strongly implied that information is a valuable means for people suffering from LBP in terms of coping appropriately. Most studies have tested the effect of information as part of a multimodal intervention.

Four Nordic studies testing the effect of 'reassuring information' based on the 'Functional Disturbance'-model (proposed by Indahl et al. 1999 - also called the 'non-injury'-model) have all been effective at positively altering the functional level and/or days of sickness absence - when provided in combination with other elements to people with subacute/chronic back pain. The present study set out to test the effect of this kind of resassuring information alone.

Between November 2012 and September 2013, we included app. 500 municipal workers perfoming either manual work, administrative work or a combination of the two. Participants worked in 5 different municipal workplaces. These workplaces were characterized by being devided into 'natural working unit', which had no or very little daily contact. All 5 workplaces participated with at least 2 units. Thus 11 units contributed to the data. Baseline assessment took place during right upon recruitment prior to randomization.

We cluster-randomized the 11 units into an intervention and a control group using a simple stepwise randomization-metod.

The intervention group received two 45-minute lectures at the workplace with an interval of 2 weeks. The lectures were coherent allthough different. They consisted of information on the scientific knowledge on the etiology of LBP, basic anatomy, common myths about LBP, a theory of non-specific LBP being caused by muscular functional disturbances (Indahl 1999), pain physiology, and scientific knowledge on seemingly appropriate coping strategies to prevent a prolonged course. Emphasis was made to reduce pain-related fear of movement and catastrophizing thoughts and beliefs. Instead, activity during pain episodes was promoted as well as a natural use of the back despite pain. A non-directive approach was used (non-imperativ wording and absence of giving advice). The purpose was to provide information but let the participant make their own conclusions on how and if to use the information in present/future coping with pain.

In addition to the lecture, the intervention group participants were provided with a leaflet showing various relevenat stretching exercises (back and related muscles) and they were offered the option to make a call to the primary investigator in case any questions would arise subsequently.

The control group was untreated by us. Both groups had access to all 'usual' help (workplace, general practitioner etc).

Upon completion of the lectures, twelve monthly assessments were conducted using Text Messaging (SMS). During each assessment, participants answered questions on no. of LBP days, no. of LBP-related cutdown days, no. of LBP-related sick days, no. of LBP-related healthcare visits, overall workability, bothersomeness last week, restricted activity last week, and use of pain medicine or degree of sadness/depression.

In addition, a separate assessment was performed at app. 5.5 monts to obtain responses on back beliefs.

The data collection was completed in 2014. Analysis are nearly finished. The sicentific paper on the study is anticipated to take place in the beginning of 2016.

Tipo de estudio

Intervencionista

Inscripción (Actual)

505

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

      • Glostrup, Dinamarca, 2600
        • Copenhagen Center for Back Research

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 72 años (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

Géneros elegibles para el estudio

Todos

Descripción

Inclusion Criteria:

-employed at one of the participating municipal workplaces

Exclusion Criteria:

  • pregnancy within the first 6 months of the study
  • physical or mental disease that has significant impact on the individual in terms of pain (eg. Rheumathoid disease, clinical depression)
  • present cancer disease (risk of metastasis)
  • planned stop at the workplace within the first 6 months of the study

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: Prevención
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación factorial
  • Enmascaramiento: Único

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: Intervention group
Talks on scientific status on back pain with the purpose of reducing LBP-related insecurity/fear, reducing the focus on the pain and providing participants with alternative explanation to their LBP. They were also provided with a folder (general stretching exercises) and had telephone access to health professional if they had questions about LBP during the follow-up year.
Two talks, a folder with general stretching exercises and possibility to contact health professional by telephone
Sin intervención: Control group
No intervention will be provided by the study team.

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Functional Level
Periodo de tiempo: 12 months
item 2 & 4 in the COMI (Deyo et al. 1998) cathegoric variable/numeric variable
12 months
Sickness absence (analysed as work participation)
Periodo de tiempo: 12 months
item 5 in the COMI (Deyo et al. 1998)
12 months

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
No. of monthly healthcare visits
Periodo de tiempo: 12 months
Number of monthly visits to any kind of healthcare provider
12 months
Back beliefs
Periodo de tiempo: 5.5 months
item 10 & 12-14 from the Back Beliefs Questionnaire
5.5 months

Otras medidas de resultado

Medida de resultado
Medida Descripción
Periodo de tiempo
Overall Workability
Periodo de tiempo: 12 months
single item from the Workability Index (WAI) numeric continuant variable,
12 months
Bothersomeness last week
Periodo de tiempo: 12 months
item 2 from the COMI (Deyo et al. 1998)
12 months
Restricted activity last week
Periodo de tiempo: 12 months
item 3 from the COMI (Deyo et al. 1998)
12 months

Colaboradores e Investigadores

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

Investigadores

  • Silla de estudio: Tom Bendix, Professor, Copenhagen Center for Back Research

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

1 de febrero de 2013

Finalización primaria (Actual)

1 de septiembre de 2014

Finalización del estudio (Actual)

1 de abril de 2016

Fechas de registro del estudio

Enviado por primera vez

25 de abril de 2013

Primero enviado que cumplió con los criterios de control de calidad

5 de agosto de 2013

Publicado por primera vez (Estimar)

7 de agosto de 2013

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

23 de agosto de 2017

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

22 de agosto de 2017

Última verificación

1 de agosto de 2017

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • VRRPhDPF
  • PF2013 (Identificador de registro: Pernille Frederiksen)

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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