Clinical trial NCT02704845: Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain
Official title: Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain: An Exploration of Similarities and Differences
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Back Pain
Spondylitis, Ankylosing
Low Back Pain
Keywords: Inflammatory back pain
Ankylosing spondylitis
Non-specific low back pain
Pain experience
Disability
Behavioural
Psychological
Biopsychosocial
Pain profiles
Lead sponsor: University of Dublin, Trinity College
Sponsor class: OTHER
First posted: 2016-03-10
Enrollment: 58
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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.

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.

Eligibility 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

Primary outcomes:
measure: Back pain intensity - total
timeFrame: Day 1, no follow-up will be required.
measure: Back pain-related functional disability
timeFrame: Day 1, no follow-up will be required.
Secondary outcomes:
measure: Back pain beliefs
timeFrame: Day 1, no follow-up will be required.
measure: Pain-related fear, fear of movement/(re)injury
timeFrame: Day 1, no follow-up will be required.
measure: The fear-avoidance behaviours of physical activity
timeFrame: Day 1, no follow-up will be required.
measure: Pain catastrophizing behavior
timeFrame: Day 1, no follow-up will be required.
measure: Self-efficacy for AS patients
timeFrame: Day 1, no follow-up will be required.
measure: Pain cognition and coping
timeFrame: Day 1, no follow-up will be required.
measure: Psychological distress (depression & anxiety)
timeFrame: Day 1, no follow-up will be required.
measure: The extent and location of pain
timeFrame: Day 1, no follow-up will be required.
measure: Back pain intensity - nocturnal
timeFrame: Day 1, no follow-up will be required.
measure: Physical function for AS patients
timeFrame: Day 1, no follow-up will be required.
measure: Disease activity for AS patients
timeFrame: Day 1, no follow-up will be required.
measure: Disease activity for AS patients
timeFrame: Day 1, no follow-up will be required.
measure: Global well-being for AS patients
timeFrame: Day 1, no follow-up will be required.
measure: Flexibility and spinal mobility for AS patients
timeFrame: Day 1, no follow-up will be required.
measure: Chest expansion
timeFrame: Day 1, no follow-up will be required.
measure: Forward bending
timeFrame: Day 1, no follow-up will be required.
measure: Isometric endurance of the trunk extensor muscles
timeFrame: Day 1, no follow-up will be required.
measure: Isometric endurance of the the trunk flexor muscles
timeFrame: Day 1, no follow-up will be required.
measure: Grip strength
timeFrame: Day 1, no follow-up will be required.
measure: Functional performance
timeFrame: Day 1, no follow-up will be required.
measure: Functional performance and endurance
timeFrame: Day 1, no follow-up will be required.
Other outcomes:
Locations:
city: Dublin
country: Ireland
facility: Physiotherapy Department, Adelaide and Meath Incorporating the National Children's Hospital (Tallaght Hospital)
city: Dublin
country: Ireland
facility: Ankylosing Spondylitis clinic, Rheumatology Department, St. James's Hospital
city: Dublin
country: Ireland
facility: Physiotherapy Department, St. James's Hospital
Study officials:
affiliation: Trinity College Dublin, Ireland
name: Fiona Wilson
role: PRINCIPAL_INVESTIGATOR
affiliation: Trinity College Dublin, Ireland
name: Lolwah A Al-Rashed
role: PRINCIPAL_INVESTIGATOR
affiliation: St. James's Hospital, Dublin, Ireland
name: Finbar O'Shea
role: PRINCIPAL_INVESTIGATOR
affiliation: University Medical Center Göttingen, Georg-August University, Göttingen, Germany
name: Deborah Falla
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Applied Sciences and Arts of Southern Switzerland (SUPSI), Manno, Switzerland
name: Marco Barbero
role: PRINCIPAL_INVESTIGATOR
affiliation: Adelaide and Meath Hospital Dublin incorporating the National Children's Hospital (Tallaght Hospital), Dublin, Ireland
name: Aisling Brenan
role: PRINCIPAL_INVESTIGATOR
References: