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Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain

19 octobre 2016 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Description détaillée

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.

Type d'étude

Observationnel

Inscription (Réel)

58

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Irlande
      • Dublin, Irlande, D24
        • Physiotherapy Department, Adelaide and Meath Incorporating the National Children's Hospital (Tallaght Hospital)
      • Dublin, Irlande, D8
        • Ankylosing Spondylitis clinic, Rheumatology Department, St. James's Hospital
      • Dublin, Irlande, D8
        • Physiotherapy Department, St. James's Hospital

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

18 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Non

Sexes éligibles pour l'étude

Tout

Méthode d'échantillonnage

Échantillon non probabiliste

Population étudiée

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.

La description

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 d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

Cohortes et interventions

Groupe / Cohorte
Spondylarthrite ankylosante
Chronic non-specific low back pain

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Back pain intensity - total
Délai: Day 1, no follow-up will be required.
The average total back pain intensity in the last week will be measured by the Numeric Rating Scale (NRS)
Day 1, no follow-up will be required.
Back pain-related functional disability
Délai: Day 1, no follow-up will be required.
Oswestry Disability Index (ODI)
Day 1, no follow-up will be required.

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Back pain beliefs
Délai: Day 1, no follow-up will be required.
Back Beliefs Questionnaire (BBQ)
Day 1, no follow-up will be required.
Pain-related fear, fear of movement/(re)injury
Délai: Day 1, no follow-up will be required.
Tampa Scale for Kinesiophobia (TSK)
Day 1, no follow-up will be required.
The fear-avoidance behaviours of physical activity
Délai: Day 1, no follow-up will be required.
modified Fear Avoidance Behaviour Questionnaire (mFABQ)
Day 1, no follow-up will be required.
Pain catastrophizing behavior
Délai: Day 1, no follow-up will be required.
Pain catastrophizing scale (PCS)
Day 1, no follow-up will be required.
Self-efficacy for AS patients
Délai: Day 1, no follow-up will be required.
Ankylosing Spondylitis-specific Arthritis Self-Efficacy Scale (ASES-AS)
Day 1, no follow-up will be required.
Pain cognition and coping
Délai: Day 1, no follow-up will be required.
Pain Coping Inventory (PCI)
Day 1, no follow-up will be required.
Psychological distress (depression & anxiety)
Délai: Day 1, no follow-up will be required.
Hospital Anxiety and Depression Scale (HADS)
Day 1, no follow-up will be required.
The extent and location of pain
Délai: Day 1, no follow-up will be required.
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)
Day 1, no follow-up will be required.
Back pain intensity - nocturnal
Délai: Day 1, no follow-up will be required.
The average nocturnal back pain intensity in the last week will be measured by the Numeric Rating Scale (NRS)
Day 1, no follow-up will be required.
Physical function for AS patients
Délai: Day 1, no follow-up will be required.
Bath Ankylosing Spondylitis Functional Index (BASFI)
Day 1, no follow-up will be required.
Disease activity for AS patients
Délai: Day 1, no follow-up will be required.
Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Day 1, no follow-up will be required.
Disease activity for AS patients
Délai: Day 1, no follow-up will be required.
Ankylosing Spondylitis Disease Activity Score (ASDAS)
Day 1, no follow-up will be required.
Global well-being for AS patients
Délai: Day 1, no follow-up will be required.
Bath Ankylosing Spondylitis Global score (BAS-G)
Day 1, no follow-up will be required.
Flexibility and spinal mobility for AS patients
Délai: Day 1, no follow-up will be required.
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Day 1, no follow-up will be required.
Chest expansion
Délai: Day 1, no follow-up will be required.
Chest expansion will be measured circumferentially using a tape measure
Day 1, no follow-up will be required.
Forward bending
Délai: Day 1, no follow-up will be required.
Finger-to-Floor Distance in centimetres (cm) will be measured using a tape measure
Day 1, no follow-up will be required.
Isometric endurance of the trunk extensor muscles
Délai: Day 1, no follow-up will be required.
Ito test
Day 1, no follow-up will be required.
Isometric endurance of the the trunk flexor muscles
Délai: Day 1, no follow-up will be required.
Shirado test
Day 1, no follow-up will be required.
Grip strength
Délai: Day 1, no follow-up will be required.
Hand grip dynamometer (Jamar Hydraulic Hand Dynamometer)
Day 1, no follow-up will be required.
Functional performance
Délai: Day 1, no follow-up will be required.
50-foot walk test
Day 1, no follow-up will be required.
Functional performance and endurance
Délai: Day 1, no follow-up will be required.
6-min walk distance (6MWD) test
Day 1, no follow-up will be required.

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

University of Dublin, Trinity College

Les enquêteurs

  • Chercheur principal: Fiona Wilson, Trinity College Dublin, Ireland
  • Chercheur principal: Lolwah A Al-Rashed, Trinity College Dublin, Ireland
  • Chercheur principal: Finbar O'Shea, St. James's Hospital, Dublin, Ireland
  • Chercheur principal: Deborah Falla, University Medical Center Göttingen, Georg-August University, Göttingen, Germany
  • Chercheur principal: Marco Barbero, University of Applied Sciences and Arts of Southern Switzerland (SUPSI), Manno, Switzerland
  • Chercheur principal: Aisling Brenan, Adelaide and Meath Hospital Dublin incorporating the National Children's Hospital (Tallaght Hospital), Dublin, Ireland

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 septembre 2015

Achèvement primaire (Réel)

1 août 2016

Achèvement de l'étude (Réel)

1 août 2016

Dates d'inscription aux études

Première soumission

27 février 2016

Première soumission répondant aux critères de contrôle qualité

4 mars 2016

Première publication (Estimation)

10 mars 2016

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

21 octobre 2016

Dernière mise à jour soumise répondant aux critères de contrôle qualité

19 octobre 2016

Dernière vérification

1 octobre 2016

Plus d'information

Termes liés à cette étude

Mots clés

Termes MeSH pertinents supplémentaires

Autres numéros d'identification d'étude

  • UDublinTC 12

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