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- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico NCT02704845
Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain
Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain: An Exploration of Similarities and Differences
Descripción general del estudio
Estado
Condiciones
Descripción detallada
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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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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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
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.
Descripción
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
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
Cohortes e Intervenciones
Grupo / Cohorte |
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Espondilitis anquilosante
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Chronic non-specific low back pain
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Back pain intensity - total
Periodo de tiempo: 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
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Back pain beliefs
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
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
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Infecciones
- Dolor
- Manifestaciones neurológicas
- Enfermedades Articulares
- Enfermedades musculoesqueléticas
- Artritis
- Enfermedades de la columna
- Enfermedades óseas
- Espondiloartropatías
- Enfermedades De Los Huesos Infecciosas
- Anquilosis
- Dolor de espalda
- Lumbalgia
- Espondilitis
- Espondiloartritis
- Espondilitis Anquilosante
Otros números de identificación del estudio
- UDublinTC 12
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