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NCT Number: NCT02704845

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

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.

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Key information

Conditions

Back Pain Ankylosis Arthritis Axial Spondyloarthritis Bone Diseases Joint Diseases Low Back Pain Musculoskeletal Diseases Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Spinal Diseases Spondylarthritis Spondylarthropathies Spondylitis Spondylitis, Ankylosing

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Ankylosing Spondylitis clinic, Rheumatology Department, St. James's Hospital, Dublin, Ireland

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Back pain intensity - total

    Time frame: 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)

  2. Back pain-related functional disability

    Time frame: Day 1, no follow-up will be required.

    Oswestry Disability Index (ODI)

Secondary outcomes

  1. Back pain beliefs

    Time frame: Day 1, no follow-up will be required.

    Back Beliefs Questionnaire (BBQ)

  2. Pain-related fear, fear of movement/(re)injury

    Time frame: Day 1, no follow-up will be required.

    Tampa Scale for Kinesiophobia (TSK)

  3. The fear-avoidance behaviours of physical activity

    Time frame: Day 1, no follow-up will be required.

    modified Fear Avoidance Behaviour Questionnaire (mFABQ)

  4. Pain catastrophizing behavior

    Time frame: Day 1, no follow-up will be required.

    Pain catastrophizing scale (PCS)

  5. Self-efficacy for AS patients

    Time frame: Day 1, no follow-up will be required.

    Ankylosing Spondylitis-specific Arthritis Self-Efficacy Scale (ASES-AS)

  6. Pain cognition and coping

    Time frame: Day 1, no follow-up will be required.

    Pain Coping Inventory (PCI)

  7. Psychological distress (depression & anxiety)

    Time frame: Day 1, no follow-up will be required.

    Hospital Anxiety and Depression Scale (HADS)

  8. The extent and location of pain

    Time frame: 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)

  9. Back pain intensity - nocturnal

    Time frame: 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)

  10. Physical function for AS patients

    Time frame: Day 1, no follow-up will be required.

    Bath Ankylosing Spondylitis Functional Index (BASFI)

  11. Disease activity for AS patients

    Time frame: Day 1, no follow-up will be required.

    Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)

  12. Disease activity for AS patients

    Time frame: Day 1, no follow-up will be required.

    Ankylosing Spondylitis Disease Activity Score (ASDAS)

  13. Global well-being for AS patients

    Time frame: Day 1, no follow-up will be required.

    Bath Ankylosing Spondylitis Global score (BAS-G)

  14. Flexibility and spinal mobility for AS patients

    Time frame: Day 1, no follow-up will be required.

    Bath Ankylosing Spondylitis Metrology Index (BASMI)

  15. Chest expansion

    Time frame: Day 1, no follow-up will be required.

    Chest expansion will be measured circumferentially using a tape measure

  16. Forward bending

    Time frame: Day 1, no follow-up will be required.

    Finger-to-Floor Distance in centimetres (cm) will be measured using a tape measure

  17. Isometric endurance of the trunk extensor muscles

    Time frame: Day 1, no follow-up will be required.

    Ito test

  18. Isometric endurance of the the trunk flexor muscles

    Time frame: Day 1, no follow-up will be required.

    Shirado test

  19. Grip strength

    Time frame: Day 1, no follow-up will be required.

    Hand grip dynamometer (Jamar Hydraulic Hand Dynamometer)

  20. Functional performance

    Time frame: Day 1, no follow-up will be required.

    50-foot walk test

  21. Functional performance and endurance

    Time frame: Day 1, no follow-up will be required.

    6-min walk distance (6MWD) test

Sponsors and collaborators

Lead sponsor

University of Dublin, Trinity College

Other

Registry information

Official study title

Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain: An Exploration of Similarities and Differences

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Mar 10, 2016
Registry last updated
Oct 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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