Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain
19 de outubro de 2016 atualizado por: Lolwah Al-Rashed, University of Dublin, Trinity College
Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain: An Exploration of Similarities and Differences
The biopsychosocial model is well established in chronic low back pain (CLBP) research.
Nevertheless, researchers to date have overlooked the biopsychosocial aspects of Inflammatory Low Back pain (ILBP).
Most health care providers are biologically oriented in their treatment of ILBP, neglecting its possible multidimensional nature.
It is true that people with ILBP may present with more complex pain and physical limitations than those with chronic non-specific low back pain (CNSLBP), but it remains unexplored whether or not these limitations are affected by the same pain factors that affect CNSLBP patients.
This study aims to explore and compare the biopsychosocial back pain profiles of adults with ILBP and CNSLBP.
Visão geral do estudo
Status
Concluído
Condições
Descrição detalhada
This is a multicentre case-control study that will compare back pain in patients with ankylosing spondylitis and CNSLBP.
A multidimensional pain assessment will be conducted for patients in both groups.
Each patient will be assessed on one occasion by the same experienced physiotherapist.
Tipo de estudo
Observacional
Inscrição (Real)
58
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
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Dublin, Irlanda, D24
- Physiotherapy Department, Adelaide and Meath Incorporating the National Children's Hospital (Tallaght Hospital)
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Dublin, Irlanda, D8
- Ankylosing Spondylitis clinic, Rheumatology Department, St. James's Hospital
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Dublin, Irlanda, D8
- Physiotherapy Department, St. James's Hospital
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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
Método de amostragem
Amostra Não Probabilística
População do estudo
A convenience sample of adults with Ankylosing Spondylitis (AS) will be consecutively recruited from a pool of patients referred to AS clinic in the Rheumatology and Physiotherapy Departments of St. James's and Tallaght Hospitals in Dublin.
Adults with chronic non-specifi low back pain (CNSLBP) (control group) will be consecutively recruited from a pool of patients referred to the Physiotherapy Department of St. James's and Tallaght Hospitals in Dublin. An invitation to participate in the study and an information leaflet will be extended to the patients who potentially meet the recruitment criteria.
Descrição
Inclusion Criteria:
- Adult between 18 and 65 years of age
- Low back pain >3 months
- On stable medication
- Ability to walk independently without an assistive device
- Specific inclusion criteria for AS group: clinical diagnosis of ankylosing spondylitis by a rheumatologist
- Specific inclusion for CNSLBP group: clinical diagnosis by a physician for CLBP
Exclusion Criteria:
- Spinal surgery or compression fracture within the last 6 months
- Cauda equine and conus medullaris syndromes
- Severe musculoskeletal conditions affecting the upper and/or the lower limbs, such as severe inflammatory arthritis of the peripheral joints
- Severe osteoporosis
- Leg-length discrepancy
- Cancer
- Morbid obesity, or pregnancy
- Progressive neurological disease
- Psychiatric disease and/or cognitive limitations that could affect the ability to complete the study questionnaires
- Inability to read and/or understand the English language
- Severe cardiac, respiratory or neurological diseases
- Uncontrolled epilepsy
- Specific exclusion criteria for CNSLBP group: Spondyloarthropathy, or any structural abnormalities in the lumbar spine that result in serious neurological dysfunction, such as stage III-IV lumbar disc herniation, and grade III-IV spondylolisthesis
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
Coortes e Intervenções
Grupo / Coorte |
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Espondilite anquilosante
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Chronic non-specific low back pain
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
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Back pain intensity - total
Prazo: Day 1, no follow-up will be required.
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The average total back pain intensity in the last week will be measured by the Numeric Rating Scale (NRS)
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Day 1, no follow-up will be required.
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Back pain-related functional disability
Prazo: Day 1, no follow-up will be required.
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Oswestry Disability Index (ODI)
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Day 1, no follow-up will be required.
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Back pain beliefs
Prazo: Day 1, no follow-up will be required.
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Back Beliefs Questionnaire (BBQ)
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Day 1, no follow-up will be required.
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Pain-related fear, fear of movement/(re)injury
Prazo: Day 1, no follow-up will be required.
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Tampa Scale for Kinesiophobia (TSK)
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Day 1, no follow-up will be required.
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The fear-avoidance behaviours of physical activity
Prazo: Day 1, no follow-up will be required.
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modified Fear Avoidance Behaviour Questionnaire (mFABQ)
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Day 1, no follow-up will be required.
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Pain catastrophizing behavior
Prazo: Day 1, no follow-up will be required.
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Pain catastrophizing scale (PCS)
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Day 1, no follow-up will be required.
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Self-efficacy for AS patients
Prazo: Day 1, no follow-up will be required.
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Ankylosing Spondylitis-specific Arthritis Self-Efficacy Scale (ASES-AS)
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Day 1, no follow-up will be required.
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Pain cognition and coping
Prazo: Day 1, no follow-up will be required.
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Pain Coping Inventory (PCI)
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Day 1, no follow-up will be required.
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Psychological distress (depression & anxiety)
Prazo: Day 1, no follow-up will be required.
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Hospital Anxiety and Depression Scale (HADS)
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Day 1, no follow-up will be required.
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The extent and location of pain
Prazo: Day 1, no follow-up will be required.
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Pain drawings will be completed for NSCLBP patients on a digital tablet (iPad 2, Apple Computer, Cupertino, CA, USA) using a commercially available sketching software (SketchBook)
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Day 1, no follow-up will be required.
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Back pain intensity - nocturnal
Prazo: Day 1, no follow-up will be required.
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The average nocturnal back pain intensity in the last week will be measured by the Numeric Rating Scale (NRS)
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Day 1, no follow-up will be required.
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Physical function for AS patients
Prazo: Day 1, no follow-up will be required.
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Bath Ankylosing Spondylitis Functional Index (BASFI)
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Day 1, no follow-up will be required.
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Disease activity for AS patients
Prazo: Day 1, no follow-up will be required.
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Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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Day 1, no follow-up will be required.
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Disease activity for AS patients
Prazo: Day 1, no follow-up will be required.
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Ankylosing Spondylitis Disease Activity Score (ASDAS)
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Day 1, no follow-up will be required.
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Global well-being for AS patients
Prazo: Day 1, no follow-up will be required.
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Bath Ankylosing Spondylitis Global score (BAS-G)
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Day 1, no follow-up will be required.
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Flexibility and spinal mobility for AS patients
Prazo: Day 1, no follow-up will be required.
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Bath Ankylosing Spondylitis Metrology Index (BASMI)
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Day 1, no follow-up will be required.
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Chest expansion
Prazo: Day 1, no follow-up will be required.
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Chest expansion will be measured circumferentially using a tape measure
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Day 1, no follow-up will be required.
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Forward bending
Prazo: Day 1, no follow-up will be required.
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Finger-to-Floor Distance in centimetres (cm) will be measured using a tape measure
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Day 1, no follow-up will be required.
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Isometric endurance of the trunk extensor muscles
Prazo: Day 1, no follow-up will be required.
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Ito test
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Day 1, no follow-up will be required.
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Isometric endurance of the the trunk flexor muscles
Prazo: Day 1, no follow-up will be required.
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Shirado test
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Day 1, no follow-up will be required.
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Grip strength
Prazo: Day 1, no follow-up will be required.
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Hand grip dynamometer (Jamar Hydraulic Hand Dynamometer)
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Day 1, no follow-up will be required.
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Functional performance
Prazo: Day 1, no follow-up will be required.
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50-foot walk test
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Day 1, no follow-up will be required.
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Functional performance and endurance
Prazo: Day 1, no follow-up will be required.
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6-min walk distance (6MWD) test
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Day 1, no follow-up will be required.
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Fiona Wilson, Trinity College Dublin, Ireland
- Investigador principal: Lolwah A Al-Rashed, Trinity College Dublin, Ireland
- Investigador principal: Finbar O'Shea, St. James's Hospital, Dublin, Ireland
- Investigador principal: Deborah Falla, University Medical Center Göttingen, Georg-August University, Göttingen, Germany
- Investigador principal: Marco Barbero, University of Applied Sciences and Arts of Southern Switzerland (SUPSI), Manno, Switzerland
- Investigador principal: Aisling Brenan, Adelaide and Meath Hospital Dublin incorporating the National Children's Hospital (Tallaght Hospital), Dublin, Ireland
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
1 de setembro de 2015
Conclusão Primária (Real)
1 de agosto de 2016
Conclusão do estudo (Real)
1 de agosto de 2016
Datas de inscrição no estudo
Enviado pela primeira vez
27 de fevereiro de 2016
Enviado pela primeira vez que atendeu aos critérios de CQ
4 de março de 2016
Primeira postagem (Estimativa)
10 de março de 2016
Atualizações de registro de estudo
Última Atualização Postada (Estimativa)
21 de outubro de 2016
Última atualização enviada que atendeu aos critérios de controle de qualidade
19 de outubro de 2016
Última verificação
1 de outubro de 2016
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- UDublinTC 12
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