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The Association Between STarT Back Tool Subgroups and Postural Stability

1 de fevereiro de 2019 atualizado por: Allan Riis, Aalborg University Hospital

The Association Between STarT Back Tool Subgroups of Patients With Low Back Pain and Postural Stability Under Conditions of Sensory Deprivation and Cognitive Load

Purpose This trial study the association between SBT subgroups and postural stability. It is theorized that cognitive impairment is more pronounced among patients in SBT group three compared to SBT group one and two. Therefore, it is hypothesized that challenging patients' balance will have a greater impact on the postural sway among patients in SBT group three compared to SBT group one and two in conditions where sensory information is reduced and cognitive load is increased.

Visão geral do estudo

Status

Concluído

Condições

Descrição detalhada

Globally low back pain (LBP) and neck pain are the leading causes of disability (1). Consequently, improvements in the assessment and treatment of LBP can have an extensive impact. Patients with LBP constitute a heterogeneous group and to improve treatment there is much focus on identifying subgroups of patients and tailor treatment accordingly. An example of this is the STarT Back Tool (SBT) which has been translated to more than 20 languages and is probably the most used tool for subgrouping of patients with LBP. The SBT sub-groups patients into three groups with a progressing need for treatment. Patients in group one should be given information on LBP and advice to stay active, patients in group two are also recommended supplementary treatment in primary care, and in addition patients in group three need attention to psycho-social issues (2-3). Accordingly to the SBT, patient in group three should be treated with cognitive therapy by a physiotherapist undergoing special training. This training includes mentorship and professional support to enable physiotherapists to elicit and address complex issues in patients with psycho-social barriers to recovery. Subgrouping by SBT and thereby treating patients in group three with cognitive therapy has been found effective in improving their functional outcomes (4-5).

Patients with LBP have found to have different postural control strategies than patients without LBP especially during tasks involving increased task complexity (6-7). However, some studies have not found decreased postural control among patients whit LBP (8-9). Heterogeneous study populations may explain the discrepancy in findings especially if subgroups of patients with LBP have affected postural control while other subgroups are not affected.

Patients with pain often present with some degree of cognitive impairments which could limit the extent to which daily activities could be performed. This may be particularly present among SBT group three patients. Cognitive impairments have been associated with decreased function and consequently reduced balance in elderly, indicating that postural stability requires significant amount of cognitive resource. Since the cognitive resources are limited, if additional tasks compete for these resources, performance in one or more tasks can become affected. The conscious interpretation of (or attention towards) painful stimulations is a costly process that uses significant amount of the cognitive resources available which could impair physical performance. Consequently, this may lead to additional postural sway and thereby restricted balance.

After given written informed consent patients fill in a questionnaire including age, gender, educational level (bachelor, yes/no), employment, sick leave, co-morbidity (other than LBP, yes/no), pain duration (2-6 weeks/sub-acute or chronic), pain intensity (NPR), Roland Morris Disability Questionnaire (23 question, RMDQ), self-reported health status (EQ-5D visual analogue scale). After filling in the questionnaire patients will be asked to take of their jacket and shoes and to empty their pockets, before measuring height, weight, and testing for static balance.

Postural sway will be measured using a force plate (Metitur Good Balance System®). The force plate will be placed with a distance of 100 cm to a wall in front of the patient and with more than 100 cm of free space to the sides and behind the force plate. The force plate, an equilateral triangle (800 mm), had four strain gauge transducer signals converted by a three-channel DC amplifier and transformed to digital data (50 Hz) and subsequently filtered digitally, using a three-point median filter and IRR filter, with 20 Hz cut-off frequency. On the wall in front of the patient a 12 cm circular green plate will be place in the patients' eye level. Patients will be asked to stand with their feet as closed positioned as possible, without lifting their feet, and to focus on the green plate in front of them. Patients will be asked to replicate this position for each test. The static balance test will require that the subjects stand as quiet as possible during 35 seconds in 4 different conditions in the following order: (i) eyes open and easy counting, (ii) eyes closed and easy counting, (iii) eyes closed and counting in multiples of seven, and (iv) eyes closed and counting backward from 500 in multiples of seven.

The force platform, scale, and person altimeter will be calibrated every fortnight or more frequent. Data will be extracted, checked for any abnormal discrepancies, and saved on a secure driver frequently (at least every fortnight).

Tipo de estudo

Intervencional

Inscrição (Real)

65

Estágio

  • Não aplicável

Contactos e Locais

Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.

Locais de estudo

      • Aalborg, Dinamarca, 9200
        • Sofiendal fysioterapi og kiropraktik

Critérios de participação

Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.

Critérios de elegibilidade

Idades elegíveis para estudo

18 anos a 65 anos (Adulto, Adulto mais velho)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Low back pain for more than 14 days

Exclusion Criteria:

  • Signs of serious pathology (e.g. signs of fracture, cauda equina syndrome, malignancy, osteoporosis, or spinal inflammatory arthritis)
  • Blindness
  • Dyslexia and not able to reply questionnaires unassisted
  • Pregnancy
  • Not able to walk unassisted

Plano de estudo

Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.

Como o estudo é projetado?

Detalhes do projeto

  • Finalidade Principal: Diagnóstico
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Triplo

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: STarT Back Tool group 3
Patients scored as high risk patients by the STarT Back Tool
Postural sway will be measured using a force plate (Metitur Good Balance System®).
Experimental: STarT Back Tool groups 1+2
Patients scored as low risk or medium risk patients by the STarT Back Tool
Postural sway will be measured using a force plate (Metitur Good Balance System®).

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Medial-Lateral body sway
Prazo: This is a cross sectional study all data will be collected during a 30 minute-session. The two balance tests for the primary outcome will be performed with a 1 minute interval.
Additional medial-lateral body sway accessed by analysis of the Center of Pressure (CoP) position. Measured as the difference in medial-lateral CoP range (cm) between a difficult 30 sec. test (eyes closed and difficult counting backwards in multiples of seven) and an easy 30 sec. test (open eyes and easy counting forwards).
This is a cross sectional study all data will be collected during a 30 minute-session. The two balance tests for the primary outcome will be performed with a 1 minute interval.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Medial-Lateral body sway
Prazo: This is a cross sectional study all data will be collected during a 30 minute-session. The three balance tests will be performed consecutively within 2 minutes interval.
Additional medial-lateral body sway accessed by analysis of the Center of Pressure (CoP) position. Measured as the difference in medial-lateral CoP range (cm) between a medium 30 sec. test (eyes closed and counting forwards in multiples of seven), a medium-easy 30 sec. test (eyes closed and easy counting backwards), and an easy 30 sec. test (open eyes and easy counting forwards).
This is a cross sectional study all data will be collected during a 30 minute-session. The three balance tests will be performed consecutively within 2 minutes interval.
Medial-Lateral body sway
Prazo: This is a cross sectional study all data will be collected during a 30 minute-session. The four balance tests will be consecutively within 3 minutes interval.
Additional medial-lateral body sway will be accessed by analysis of the difference in CoP; velocity (cm/s) between a difficult 30 sec. test (eyes closed and difficult counting backwards in multiples of seven), a medium 30 sec. test (eyes closed and counting forwards in multiples of seven), a medium-easy 30 sec. test (eyes closed and easy counting backwards), and an easy 30 sec. test (open eyes and easy counting forwards).
This is a cross sectional study all data will be collected during a 30 minute-session. The four balance tests will be consecutively within 3 minutes interval.
Anterior-Posterior body sway
Prazo: This is a cross sectional study all data will be collected during a 30 minute-session. The four balance tests will be consecutively within 3 minutes interval.
Additional anterior-posterior body sway will be accessed by analysis of the difference in CoP; range (cm) between a difficult 30 sec. test (eyes closed and difficult counting backwards in multiples of seven), a medium 30 sec. test (eyes closed and counting forwards in multiples of seven), a medium-easy 30 sec. test (eyes closed and easy counting backwards), and an easy 30 sec. test (open eyes and easy counting forwards).
This is a cross sectional study all data will be collected during a 30 minute-session. The four balance tests will be consecutively within 3 minutes interval.
Anterior-Posterior body sway
Prazo: This is a cross sectional study all data will be collected during a 30 minute-session. The four balance tests will be consecutively within 3 minutes interval.
Additional anterior-posterior body sway will be accessed by analysis of the difference in CoP; velocity (cm/s) between a difficult 30 sec. test (eyes closed and difficult counting backwards in multiples of seven), a medium 30 sec. test (eyes closed and counting forwards in multiples of seven), a medium-easy 30 sec. test (eyes closed and easy counting backwards), and an easy 30 sec. test (open eyes and easy counting forwards).
This is a cross sectional study all data will be collected during a 30 minute-session. The four balance tests will be consecutively within 3 minutes interval.
Body sway area
Prazo: This is a cross sectional study all data will be collected during a 30 minute-session. The four balance tests will be consecutively within 3 minutes interval.
Additional sway area accessed by area of an ellipse fitted to the 95% confidence interval of the Center of Pressure position (cm2). Measured as the difference in area (cm2) between a difficult 30 sec. test (eyes closed and difficult counting backwards in multiples of seven), a medium 30 sec. test (eyes closed and counting forwards in multiples of seven), a medium-easy 30 sec. test (eyes closed and easy counting backwards), and an easy 30 sec. test (open eyes and easy counting forwards).
This is a cross sectional study all data will be collected during a 30 minute-session. The four balance tests will be consecutively within 3 minutes interval.

Colaboradores e Investigadores

É aqui que você encontrará pessoas e organizações envolvidas com este estudo.

Colaboradores

Investigadores

  • Investigador principal: Allan Riis, PhD, Research unit for General Practice in Aalborg, Denmark

Publicações e links úteis

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Publicações Gerais

Datas de registro do estudo

Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados ​​pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.

Datas Principais do Estudo

Início do estudo (Real)

4 de fevereiro de 2017

Conclusão Primária (Real)

1 de fevereiro de 2019

Conclusão do estudo (Real)

1 de fevereiro de 2019

Datas de inscrição no estudo

Enviado pela primeira vez

17 de fevereiro de 2017

Enviado pela primeira vez que atendeu aos critérios de CQ

22 de fevereiro de 2017

Primeira postagem (Real)

28 de fevereiro de 2017

Atualizações de registro de estudo

Última Atualização Postada (Real)

4 de fevereiro de 2019

Última atualização enviada que atendeu aos critérios de controle de qualidade

1 de fevereiro de 2019

Última verificação

1 de fevereiro de 2019

Mais Informações

Termos relacionados a este estudo

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • AllanRiis_6

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

Não

Descrição do plano IPD

The data analysed will be available from the corresponding author on reasonable request.

Informações sobre medicamentos e dispositivos, documentos de estudo

Estuda um medicamento regulamentado pela FDA dos EUA

Não

Estuda um produto de dispositivo regulamentado pela FDA dos EUA

Não

produto fabricado e exportado dos EUA

Não

Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .

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