Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain
19. oktober 2016 oppdatert av: 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.
Studieoversikt
Status
Fullført
Detaljert beskrivelse
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
Observasjonsmessig
Registrering (Faktiske)
58
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Dublin, Irland, D24
- Physiotherapy Department, Adelaide and Meath Incorporating the National Children's Hospital (Tallaght Hospital)
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Dublin, Irland, D8
- Ankylosing Spondylitis clinic, Rheumatology Department, St. James's Hospital
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Dublin, Irland, D8
- Physiotherapy Department, St. James's Hospital
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 65 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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.
Beskrivelse
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
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
Kohorter og intervensjoner
Gruppe / Kohort |
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Ankyloserende spondylitt
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Chronic non-specific low back pain
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Back pain intensity - total
Tidsramme: 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
Tidsramme: Day 1, no follow-up will be required.
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Oswestry Disability Index (ODI)
|
Day 1, no follow-up will be required.
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Back pain beliefs
Tidsramme: Day 1, no follow-up will be required.
|
Back Beliefs Questionnaire (BBQ)
|
Day 1, no follow-up will be required.
|
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Pain-related fear, fear of movement/(re)injury
Tidsramme: Day 1, no follow-up will be required.
|
Tampa Scale for Kinesiophobia (TSK)
|
Day 1, no follow-up will be required.
|
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The fear-avoidance behaviours of physical activity
Tidsramme: Day 1, no follow-up will be required.
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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)
Tidsramme: 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
Tidsramme: 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.
|
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Back pain intensity - nocturnal
Tidsramme: 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.
|
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Physical function for AS patients
Tidsramme: Day 1, no follow-up will be required.
|
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
Tidsramme: Day 1, no follow-up will be required.
|
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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: Day 1, no follow-up will be required.
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Chest expansion will be measured circumferentially using a tape measure
|
Day 1, no follow-up will be required.
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Forward bending
Tidsramme: 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.
|
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Isometric endurance of the trunk extensor muscles
Tidsramme: Day 1, no follow-up will be required.
|
Ito test
|
Day 1, no follow-up will be required.
|
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Isometric endurance of the the trunk flexor muscles
Tidsramme: 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
Tidsramme: Day 1, no follow-up will be required.
|
Hand grip dynamometer (Jamar Hydraulic Hand Dynamometer)
|
Day 1, no follow-up will be required.
|
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Functional performance
Tidsramme: Day 1, no follow-up will be required.
|
50-foot walk test
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Day 1, no follow-up will be required.
|
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Functional performance and endurance
Tidsramme: 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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- Hovedetterforsker: Fiona Wilson, Trinity College Dublin, Ireland
- Hovedetterforsker: Lolwah A Al-Rashed, Trinity College Dublin, Ireland
- Hovedetterforsker: Finbar O'Shea, St. James's Hospital, Dublin, Ireland
- Hovedetterforsker: Deborah Falla, University Medical Center Göttingen, Georg-August University, Göttingen, Germany
- Hovedetterforsker: Marco Barbero, University of Applied Sciences and Arts of Southern Switzerland (SUPSI), Manno, Switzerland
- Hovedetterforsker: Aisling Brenan, Adelaide and Meath Hospital Dublin incorporating the National Children's Hospital (Tallaght Hospital), Dublin, Ireland
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. september 2015
Primær fullføring (Faktiske)
1. august 2016
Studiet fullført (Faktiske)
1. august 2016
Datoer for studieregistrering
Først innsendt
27. februar 2016
Først innsendt som oppfylte QC-kriteriene
4. mars 2016
Først lagt ut (Anslag)
10. mars 2016
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
21. oktober 2016
Siste oppdatering sendt inn som oppfylte QC-kriteriene
19. oktober 2016
Sist bekreftet
1. oktober 2016
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- UDublinTC 12
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