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LOw Level of Activity (LOLA): Education and Exercise-based Intervention for Low Back Pain (LOLA)

31 de março de 2021 atualizado por: University of the Balearic Islands

Behavioral Activation and Exercise Protocol for Chronic Pain Patients Based on the Use of New Technologies (Smartphone)

Chronic pain of moderate to severe intensity occurs in 19% of adult Europeans. Non-specific low-back pain is one of the most prevalent symptoms and the main cause of disability in industrialized countries, generating significant public health expenditure on health and occupational care. The combination of pain neurophysiology education and therapeutic exercise has shown positive effects in patients with chronic non-specific low back pain. Mobile health tools (mHealth) are proposed as a cost-effective alternative to continuously record the daily activities of patients and to provide rapid feedback to users and clinicians, reducing visits to clinics. A 4-week (8-session) education and exercise-based intervention will be carried out in a group of patients with non-specific chronic low back pain using two modalities: (1) face-to-face guided by a health professional or (2) self-managed through BackFit App. The sample will be divided into two groups and will be evaluated before (pre), after (post) and 3 months (follow-up) after the intervention.

Visão geral do estudo

Status

Concluído

Condições

Intervenção / Tratamento

Descrição detalhada

The objectives of this study are:

  1. To assess the influence of a 4-week (8 sessions) intervention based on education (about pain neurophysiology and healthy lifestyle habits) and physical exercise (strength, flexibility, joint mobility, and self-massage) on pressure pain thresholds (PPT) and cognitive functioning (selective attention), as primary variable outcomes, and on physical condition (balance and range of movement), affective and cognitive symptoms (mood, anxiety, catastrophizing, fear-avoidance beliefs and kinesiophobia), pain interference and self-reported clinical pain, as secondary variable outcomes, in patients with non-specific chronic low back pain.
  2. To evaluate the effectiveness of a mobile health application developed by researchers (BackFit App) to carry out the intervention, in comparison with a supervised intervention by a health professional.

The hypotheses of the study are:

  1. This intervention based on education and physical exercise will increase PPT and improve selective attention.
  2. This intervention will also improve physical condition, self-reported clinical pain, affective and cognitive symptoms and pain interference presented by patients with chronic low back pain.
  3. The intervention performed with BackFit App will be as effective as that supervised by a health professional.

Tipo de estudo

Intervencional

Inscrição (Real)

59

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

  • Espanha
    • Illes Balears
      • Palma, Illes Balears, Espanha, 07122
        • University of the Balearic Islands

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 59 anos (Adulto)

Aceita Voluntários Saudáveis

Não

Gêneros Elegíveis para o Estudo

Tudo

Descrição

Inclusion Criteria:

  • Subjects between 18 and 59 years, with non-specific low back pain for more than 6 weeks and which have experienced at least 3 episodes of low back pain lasting more than 1 week during the year prior to the study, and, at the time of evaluation and/or intervention, presenting pain of mild/moderate intensity (not exceeding 5 out of 10 in a Visual Analogue Scale (VAS)).

Exclusion Criteria:

  • High functional impairment compromising activities such as walking, sitting or getting up from a chair.
  • Pain at the time of evaluation and/or intervention greater than 5 (out of 10) in a VAS.
  • Presence of irradiated pain (sciatic type) or referred to lower extremities.
  • History of spine surgery, spinal or pelvic fracture
  • Hospitalization for serious trauma or injuries due to traffic accidents.
  • History of osteoarthritis in the lower extremities.
  • History of any systematic diseases with involvement of the locomotor system.

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: Tratamento
  • Alocação: Não randomizado
  • Modelo Intervencional: Atribuição Paralela
  • Mascaramento: Solteiro

Armas e Intervenções

Grupo de Participantes / Braço
Intervenção / Tratamento
Experimental: face-to-face
A 4-week intervention (8 sessions) will be carried out in a group of patients with non-specific chronic low back pain using face-to-face modality guided by a health professional.
Outro: face-to-face protocol
The intervention is based on education (on pain neurophysiology and healthy lifestyle habits) and physical exercise (strength, flexibility, joint mobility and self-massage).
Experimental: self-managed
A 4-week intervention (8 sessions) will be carried out in a group of patients with non-specific chronic low back pain using self-managed modality through BackFit App.
Outro: self-managed protocol
Subjects of this group receive the same intervention content as the other experimental group, but through a mobile application.

O que o estudo está medindo?

Medidas de resultados primários

Medida de resultado
Descrição da medida
Prazo
Cognitive functioning assessment.
Prazo: Up to 4 weeks.
Cognitive functioning was assessed by recording electroencephalographic activity during a computerized version of the Flanker task, which measures selective attention, under two experimental conditions: congruent flanks (arrows) with the target (pointing in the same direction as the central arrow) and incongruent (pointing the opposite direction).Regarding Resting EEG a Fast Fourier Transform (FFT) analysis has been made (delta, theta, "Alpha" and beta 1, 2 and 3. The EEG during the "Flanker task" was analyzed by means of a "Cluster-based analysis". Primary outcome measures were recorded in a counterbalanced order and were measured at baseline and 4 weeks.
Up to 4 weeks.
Heart Rate Variability (HRV)
Prazo: Up to 4 weeks.
Heart Rate Variability (HRV) has been analyzed from ECG data. Primary outcome Measures were recorded in a counterbalanced order and were measured at baseline and 4 weeks.
Up to 4 weeks.
Pressure pain thresholds (PPT).
Prazo: Up to 12 weeks.
To evaluate Pressure pain thresholds (PPT )(with a maximum of 5kg/cm2) will be applied pressure on the erector spinae and index finger with an algometer (area 1cm2). Primary outcome measures were recorded in a counterbalanced order and were measured at baseline, 4 and 12 weeks.
Up to 12 weeks.

Medidas de resultados secundários

Medida de resultado
Descrição da medida
Prazo
Balance
Prazo: Up to 12 weeks.
Mono and bipedal static balance will be measured with the Wii balance board. Measurements will be performed after 15 minutes of rest once the subject arrives at baseline, 4 and 12 weeks.
Up to 12 weeks.
Range of movement
Prazo: Up to 12 weeks.
Range of movement of the hip will be measured with a goniometer. Measurements will be performed after balance measurements at baseline, 4 and Range of movement of the hip will be measured with a goniometer. Measurements will be performed after balance measurements at baseline, 4 and 12 weeks.
Up to 12 weeks.
Clinical pain
Prazo: Up to 12 weeks.
Clinical pain will be measured with Visual Analog Scale (VAS) (0-10cm) This outcome was measured at baseline, 4 and 12 weeks. A higher score indicates greater pain intensity.
Up to 12 weeks.
Pain interference
Prazo: Up to 12 weeks.
Pain interference data will be collected with the Spanish version of Oswestry Disability Index (ODI) (0-100%). This outcome was measured at baseline, 4 and 12 weeks. A higher score indicates greater functional disability.
Up to 12 weeks.
Affective symptoms (Mood)
Prazo: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks

Mood, often associated to chronic pain, will be assessed by the Spanish versions of Profile of Mood States (POMS) questionnaire.

The POMS questionnaire (Ranges from 0-200) assesses six mood subscales: tension-anxiety (0-36), anger-hostility (0-48), vigor (0-32), fatigue (0-28), depression (0-60) and confusion (0-28).

High vigor scores reflect a good mood or emotion. Low scores in the other subscales reflect a good mood or emotion
Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Affective symptoms (anxiety)
Prazo: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Anxiety, often associated to chronic pain, will be assessed by the State Trait Anxiety Inventory (STAI) questionnaire. State (0-30) and Trate (0-30). Higher scores indicates greater anxiety.
Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Cognitive symptoms (catastrophizing)
Prazo: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Other cognitive symptoms, such as catastrophyzing, will be assessed using the Spanish version of Pain Catastrophizing Scale (PCS)(Ranges from 0-52), a 13-item scale where low scores show little catastrophization, and high values, high catastrophization.
Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Cognitive symptoms (fear-avoidance beliefs)
Prazo: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Other cognitive symptoms, such as fear-avoidance beliefs will be also assessed using Fear Avoidance Beliefs Questionnaire (FABQ).(ranges from 0-96) Higher scores indicate more strongly held fear avoidance beliefs.
Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks
Cognitive symptoms (kinesiophobia)
Prazo: Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks

Other cognitive symptoms, such as kinesiophobia (or fear of movement) will be also assessed using the spanish version of Tampa Scale for Kinesiophobia (TSK).

It consists of 11 items scored from 1 (strongly disagree) to 4 (strongly agree). The higher the score, the higher the degree of kinesiophobia.
Questionnaires will be performed during rest prior to balance and range of movement measurements at baseline, 4 and 12 weeks

Colaboradores e Investigadores

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

Patrocinador

University of the Balearic Islands

Colaboradores

Ministerio de Economía y Competitividad, Spain

Investigadores

  • Investigador principal: Carolina Sitges, PhD, University of Balearic Islands, Department of Psychology

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)

6 de março de 2019

Conclusão Primária (Real)

11 de fevereiro de 2020

Conclusão do estudo (Real)

11 de fevereiro de 2020

Datas de inscrição no estudo

Enviado pela primeira vez

10 de julho de 2020

Enviado pela primeira vez que atendeu aos critérios de CQ

29 de setembro de 2020

Primeira postagem (Real)

6 de outubro de 2020

Atualizações de registro de estudo

Última Atualização Postada (Real)

2 de abril de 2021

Última atualização enviada que atendeu aos critérios de controle de qualidade

31 de março de 2021

Última verificação

1 de março de 2021

Mais Informações

Termos relacionados a este estudo

Palavras-chave

Termos MeSH relevantes adicionais

Outros números de identificação do estudo

  • PSI2015-66295

Plano para dados de participantes individuais (IPD)

Planeja compartilhar dados de participantes individuais (IPD)?

NÃO

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

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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