Deze pagina is automatisch vertaald en de nauwkeurigheid van de vertaling kan niet worden gegarandeerd. Raadpleeg de Engelse versie voor een brontekst.

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

19 oktober 2016 bijgewerkt door: 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.

Studie Overzicht

Toestand

Voltooid

Conditie

Gedetailleerde beschrijving

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.

Studietype

Observationeel

Inschrijving (Werkelijk)

58

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

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

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

18 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Nee

Geslachten die in aanmerking komen voor studie

Allemaal

Bemonsteringsmethode

Niet-waarschijnlijkheidssteekproef

Studie Bevolking

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.

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

Cohorten en interventies

Groep / Cohort
Spondylitis ankylopoetica
Chronic non-specific low back pain

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Back pain intensity - total
Tijdsspanne: 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
Tijdsspanne: Day 1, no follow-up will be required.
Oswestry Disability Index (ODI)
Day 1, no follow-up will be required.

Secundaire uitkomstmaten

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

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

University of Dublin, Trinity College

Onderzoekers

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

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 september 2015

Primaire voltooiing (Werkelijk)

1 augustus 2016

Studie voltooiing (Werkelijk)

1 augustus 2016

Studieregistratiedata

Eerst ingediend

27 februari 2016

Eerst ingediend dat voldeed aan de QC-criteria

4 maart 2016

Eerst geplaatst (Schatting)

10 maart 2016

Updates van studierecords

Laatste update geplaatst (Schatting)

21 oktober 2016

Laatste update ingediend die voldeed aan QC-criteria

19 oktober 2016

Laatst geverifieerd

1 oktober 2016

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Aanvullende relevante MeSH-voorwaarden

Andere studie-ID-nummers

  • UDublinTC 12

Deze informatie is zonder wijzigingen rechtstreeks van de website clinicaltrials.gov gehaald. Als u verzoeken heeft om uw onderzoeksgegevens te wijzigen, te verwijderen of bij te werken, neem dan contact op met register@clinicaltrials.gov. Zodra er een wijziging wordt doorgevoerd op clinicaltrials.gov, wordt deze ook automatisch bijgewerkt op onze website .

Abonneren