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

19. Oktober 2016 aktualisiert von: 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.

Studienübersicht

Status

Abgeschlossen

Bedingungen

Detaillierte Beschreibung

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.

Studientyp

Beobachtungs

Einschreibung (Tatsächlich)

58

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

18 Jahre bis 65 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Probenahmeverfahren

Nicht-Wahrscheinlichkeitsprobe

Studienpopulation

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.

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

Kohorten und Interventionen

Gruppe / Kohorte
Spondylitis ankylosans
Chronic non-specific low back pain

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Back pain intensity - total
Zeitfenster: 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
Zeitfenster: Day 1, no follow-up will be required.
Oswestry Disability Index (ODI)
Day 1, no follow-up will be required.

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Back pain beliefs
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 1, no follow-up will be required.
Pain Coping Inventory (PCI)
Day 1, no follow-up will be required.
Psychological distress (depression & anxiety)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 1, no follow-up will be required.
Bath Ankylosing Spondylitis Metrology Index (BASMI)
Day 1, no follow-up will be required.
Chest expansion
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: Day 1, no follow-up will be required.
Shirado test
Day 1, no follow-up will be required.
Grip strength
Zeitfenster: 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
Zeitfenster: Day 1, no follow-up will be required.
50-foot walk test
Day 1, no follow-up will be required.
Functional performance and endurance
Zeitfenster: Day 1, no follow-up will be required.
6-min walk distance (6MWD) test
Day 1, no follow-up will be required.

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

University of Dublin, Trinity College

Ermittler

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

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn

1. September 2015

Primärer Abschluss (Tatsächlich)

1. August 2016

Studienabschluss (Tatsächlich)

1. August 2016

Studienanmeldedaten

Zuerst eingereicht

27. Februar 2016

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

4. März 2016

Zuerst gepostet (Schätzen)

10. März 2016

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Schätzen)

21. Oktober 2016

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

19. Oktober 2016

Zuletzt verifiziert

1. Oktober 2016

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • UDublinTC 12

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