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

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.

Study Overview

• Status: Completed
• Conditions: Back Pain; Low Back Pain; Spondylitis, Ankylosing

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.

• Study Type: Observational
• Enrollment (Actual): 58

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Ankylosing Spondylitis
Chronic non-specific low back pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back pain intensity - total	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	Oswestry Disability Index (ODI)	Day 1, no follow-up will be required.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Back pain beliefs	Back Beliefs Questionnaire (BBQ)	Day 1, no follow-up will be required.
Pain-related fear, fear of movement/(re)injury	Tampa Scale for Kinesiophobia (TSK)	Day 1, no follow-up will be required.
The fear-avoidance behaviours of physical activity	modified Fear Avoidance Behaviour Questionnaire (mFABQ)	Day 1, no follow-up will be required.
Pain catastrophizing behavior	Pain catastrophizing scale (PCS)	Day 1, no follow-up will be required.
Self-efficacy for AS patients	Ankylosing Spondylitis-specific Arthritis Self-Efficacy Scale (ASES-AS)	Day 1, no follow-up will be required.
Pain cognition and coping	Pain Coping Inventory (PCI)	Day 1, no follow-up will be required.
Psychological distress (depression & anxiety)	Hospital Anxiety and Depression Scale (HADS)	Day 1, no follow-up will be required.
The extent and location of pain	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	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	Bath Ankylosing Spondylitis Functional Index (BASFI)	Day 1, no follow-up will be required.
Disease activity for AS patients	Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)	Day 1, no follow-up will be required.
Disease activity for AS patients	Ankylosing Spondylitis Disease Activity Score (ASDAS)	Day 1, no follow-up will be required.
Global well-being for AS patients	Bath Ankylosing Spondylitis Global score (BAS-G)	Day 1, no follow-up will be required.
Flexibility and spinal mobility for AS patients	Bath Ankylosing Spondylitis Metrology Index (BASMI)	Day 1, no follow-up will be required.
Chest expansion	Chest expansion will be measured circumferentially using a tape measure	Day 1, no follow-up will be required.
Forward bending	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	Ito test	Day 1, no follow-up will be required.
Isometric endurance of the the trunk flexor muscles	Shirado test	Day 1, no follow-up will be required.
Grip strength	Hand grip dynamometer (Jamar Hydraulic Hand Dynamometer)	Day 1, no follow-up will be required.
Functional performance	50-foot walk test	Day 1, no follow-up will be required.
Functional performance and endurance	6-min walk distance (6MWD) test	Day 1, no follow-up will be required.

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start: September 1, 2015
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: February 27, 2016
• First Submitted That Met QC Criteria: March 4, 2016
• First Posted (Estimate): March 10, 2016

Study Record Updates

• Last Update Posted (Estimate): October 21, 2016
• Last Update Submitted That Met QC Criteria: October 19, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: Psychological; Ankylosing spondylitis; Disability; Inflammatory back pain; Behavioural; Biopsychosocial; Non-specific low back pain; Pain experience; Pain profiles
• Additional Relevant MeSH Terms: Infections; Pain; Neurologic Manifestations; Joint Diseases; Musculoskeletal Diseases; Arthritis; Spinal Diseases; Bone Diseases; Spondylarthropathies; Bone Diseases, Infectious; Ankylosis; Back Pain; Low Back Pain; Spondylitis; Spondylarthritis; Spondylitis, Ankylosing
• Other Study ID Numbers: UDublinTC 12