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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02704845
Enrollment
58
Registered
2016-03-10
Start date
2015-09-30
Completion date
2016-08-31
Last updated
2016-10-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Back Pain, Low Back Pain, Spondylitis, Ankylosing

Keywords

Inflammatory back pain, Ankylosing spondylitis, Non-specific low back pain, Pain experience, Disability, Behavioural, Psychological, Biopsychosocial, Pain profiles

Brief summary

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.

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.

Interventions

None listed

Sponsors

University of Dublin, Trinity College
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Back pain intensity - totalDay 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)
Back pain-related functional disabilityDay 1, no follow-up will be required.Oswestry Disability Index (ODI)

Secondary

MeasureTime frameDescription
Back pain beliefsDay 1, no follow-up will be required.Back Beliefs Questionnaire (BBQ)
Pain-related fear, fear of movement/(re)injuryDay 1, no follow-up will be required.Tampa Scale for Kinesiophobia (TSK)
The fear-avoidance behaviours of physical activityDay 1, no follow-up will be required.modified Fear Avoidance Behaviour Questionnaire (mFABQ)
Pain catastrophizing behaviorDay 1, no follow-up will be required.Pain catastrophizing scale (PCS)
Self-efficacy for AS patientsDay 1, no follow-up will be required.Ankylosing Spondylitis-specific Arthritis Self-Efficacy Scale (ASES-AS)
Pain cognition and copingDay 1, no follow-up will be required.Pain Coping Inventory (PCI)
Psychological distress (depression & anxiety)Day 1, no follow-up will be required.Hospital Anxiety and Depression Scale (HADS)
The extent and location of painDay 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)
Back pain intensity - nocturnalDay 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)
Physical function for AS patientsDay 1, no follow-up will be required.Bath Ankylosing Spondylitis Functional Index (BASFI)
Disease activity for AS patientsDay 1, no follow-up will be required.Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
Global well-being for AS patientsDay 1, no follow-up will be required.Bath Ankylosing Spondylitis Global score (BAS-G)
Flexibility and spinal mobility for AS patientsDay 1, no follow-up will be required.Bath Ankylosing Spondylitis Metrology Index (BASMI)
Chest expansionDay 1, no follow-up will be required.Chest expansion will be measured circumferentially using a tape measure
Forward bendingDay 1, no follow-up will be required.Finger-to-Floor Distance in centimetres (cm) will be measured using a tape measure
Isometric endurance of the trunk extensor musclesDay 1, no follow-up will be required.Ito test
Isometric endurance of the the trunk flexor musclesDay 1, no follow-up will be required.Shirado test
Grip strengthDay 1, no follow-up will be required.Hand grip dynamometer (Jamar Hydraulic Hand Dynamometer)
Functional performanceDay 1, no follow-up will be required.50-foot walk test
Functional performance and enduranceDay 1, no follow-up will be required.6-min walk distance (6MWD) test

Countries

Ireland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026