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

NCT02704845 | Completed

• 1 other identifier: UDublinTC 12
• Study Type: observational
• Target: 58
• Locations: 1 country
• Sites: 3

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.

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

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (21)

• Back pain beliefs

  Day 1, no follow-up will be required.

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

  Day 1, no follow-up will be required.

• The fear-avoidance behaviours of physical activity

  Day 1, no follow-up will be required.

• Pain catastrophizing behavior

  Day 1, no follow-up will be required.

• Self-efficacy for AS patients

  Day 1, no follow-up will be required.

Study Arms (2)

Ankylosing Spondylitis

Chronic non-specific low back pain

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• Adult between 18 and 65 years of age
• Low back pain \>3 months
• On stable medication
• Ability to walk independently without an assistive device

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Dublin, Trinity College: lead

Study Sites (3)

Physiotherapy Department, Adelaide and Meath Incorporating the National Children's Hospital (Tallaght Hospital)

Dublin, D24, Ireland

Location

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

Dublin, D8, Ireland

Location

Physiotherapy Department, St. James's Hospital

Dublin, D8, Ireland

Location

MeSH Terms

Conditions

Back Pain; Spondylitis, Ankylosing; Low Back Pain

Condition Hierarchy (Ancestors)

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

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lead Investigator

Study Record Dates

• First Submitted: February 27, 2016
• First Posted: March 10, 2016
• Study Start: September 1, 2015
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: October 21, 2016

Record last verified: 2016-10

Locations

IE (3)