Now Available: Final Rule for FDAAA 801 and NIH Policy on Clinical Trial Reporting
Trial record 3 of 2575 for:    Back Pain

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2016 by University of Dublin, Trinity College
Sponsor:
Information provided by (Responsible Party):
Lolwah Al-Rashed, University of Dublin, Trinity College
ClinicalTrials.gov Identifier:
NCT02704845
First received: February 27, 2016
Last updated: March 4, 2016
Last verified: March 2016
  Purpose
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.

Condition
Back Pain
Spondylitis, Ankylosing
Low Back Pain

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Cross-Sectional
Official Title: Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain: An Exploration of Similarities and Differences

Resource links provided by NLM:


Further study details as provided by University of Dublin, Trinity College:

Primary Outcome Measures:
  • Back pain intensity - total [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    The average total back pain intensity in the last week will be measured by the Numeric Rating Scale (NRS)

  • Back pain intensity - nocturnal [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    The average nocturnal back pain intensity in the last week will be measured by the Numeric Rating Scale (NRS)


Secondary Outcome Measures:
  • Back pain beliefs [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Back Beliefs Questionnaire (BBQ)

  • Pain-related fear, fear of movement/(re)injury [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Tampa Scale for Kinesiophobia (TSK)

  • The fear-avoidance behaviours of physical activity [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    modified Fear Avoidance Behaviour Questionnaire (mFABQ)

  • Pain catastrophizing behavior [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Pain catastrophizing scale (PCS)

  • Self-efficacy for AS patients [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Ankylosing Spondylitis-specific Arthritis Self-Efficacy Scale (ASES-AS)

  • Pain cognition and coping [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Pain Coping Inventory (PCI)

  • Psychological distress (depression & anxiety) [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Hospital Anxiety and Depression Scale (HADS)

  • The extent and location of pain [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    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)

  • Back-related functional disability [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Oswestry Disability Index (ODI)

  • Physical function for AS patients [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Bath Ankylosing Spondylitis Functional Index (BASFI)

  • Disease activity for AS patients [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  • Disease activity for AS patients [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Ankylosing Spondylitis Disease Activity Score (ASDAS)

  • Global well-being for AS patients [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Bath Ankylosing Spondylitis Global score (BAS-G)

  • Flexibility and spinal mobility for AS patients [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Bath Ankylosing Spondylitis Metrology Index (BASMI)

  • Chest expansion [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Chest expansion will be measured circumferentially using a tape measure

  • Forward bending [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Finger-to-Floor Distance in centimetres (cm) will be measured using a tape measure

  • Isometric endurance of the trunk extensor muscles [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Ito test

  • Isometric endurance of the the trunk flexor muscles [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Shirado test

  • Grip strength [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Hand grip dynamometer (Jamar Hydraulic Hand Dynamometer)

  • Functional performance [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    Repeated sit-to-stand test

  • Functional performance [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    50-foot walk test

  • Functional performance and endurance [ Time Frame: Day 1, no follow-up will be required. ] [ Designated as safety issue: No ]
    6-min walk distance (6MWD) test


Estimated Enrollment: 70
Study Start Date: September 2015
Estimated Study Completion Date: August 2016
Estimated Primary Completion Date: July 2016 (Final data collection date for primary outcome measure)
Groups/Cohorts
Ankylosing Spondylitis
Chronic non-specific low back pain

Detailed Description:
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.
  Eligibility

Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

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.

Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02704845

Contacts
Contact: Lolwah A Al-Rashed, MSc alrashel@tcd.ie
Contact: Fiona Wilson, PhD wilsonf@tcd.ie

Locations
Ireland
Physiotherapy Department, Adelaide and Meath Incorporating the National Children's Hospital (Tallaght Hospital) Recruiting
Dublin, Ireland, D24
Ankylosing Spondylitis clinic, Rheumatology Department, St. James's Hospital Recruiting
Dublin, Ireland, D8
Physiotherapy Department, St. James's Hospital Recruiting
Dublin, Ireland, D8
Sponsors and Collaborators
University of Dublin, Trinity College
Investigators
Principal Investigator: Fiona Wilson Trinity College Dublin, Ireland
Principal Investigator: Lolwah A Al-Rashed Trinity College Dublin, Ireland
Principal Investigator: Finbar O'Shea St. James's Hospital, Dublin, Ireland
Principal Investigator: Deborah Falla University Medical Center Göttingen, Georg-August University, Göttingen, Germany
Principal Investigator: Marco Barbero University of Applied Sciences and Arts of Southern Switzerland (SUPSI), Manno, Switzerland
Principal Investigator: Aisling Brenan Adelaide and Meath Hospital Dublin incorporating the National Children's Hospital (Tallaght Hospital), Dublin, Ireland
  More Information

Responsible Party: Lolwah Al-Rashed, Lead Investigator, University of Dublin, Trinity College
ClinicalTrials.gov Identifier: NCT02704845     History of Changes
Other Study ID Numbers: UDublinTC 12 
Study First Received: February 27, 2016
Last Updated: March 4, 2016
Health Authority: Ireland: Research Ethics Committee

Keywords provided by University of Dublin, Trinity College:
Inflammatory back pain
Ankylosing spondylitis
Non-specific low back pain
Pain experience
Disability
Behavioural
Psychological
Biopsychosocial
Pain profiles

Additional relevant MeSH terms:
Back Pain
Low Back Pain
Pain
Spondylitis
Spondylitis, Ankylosing
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms
Bone Diseases, Infectious
Infection
Bone Diseases
Musculoskeletal Diseases
Spinal Diseases
Spondylarthropathies
Spondylarthritis
Ankylosis
Joint Diseases
Arthritis

ClinicalTrials.gov processed this record on September 28, 2016