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

NCT ID: NCT02704845

Last Updated: 2016-10-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 58 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2015-09-30
• Study Completion Date: 2016-08-31

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.

Conditions

Back Pain; Spondylitis, Ankylosing; Low Back Pain

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Ankylosing Spondylitis

No interventions assigned to this group

Chronic non-specific low back pain

No interventions assigned to this group

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 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Dublin, Trinity College

OTHER

Sponsor Role: lead

Responsible Party

Lolwah Al-Rashed

Lead Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Fiona Wilson

Role: PRINCIPAL_INVESTIGATOR

Trinity College Dublin, Ireland

Lolwah A Al-Rashed

Role: PRINCIPAL_INVESTIGATOR

Trinity College Dublin, Ireland

Finbar O'Shea

Role: PRINCIPAL_INVESTIGATOR

St. James's Hospital, Dublin, Ireland

Deborah Falla

Role: PRINCIPAL_INVESTIGATOR

University Medical Center Göttingen, Georg-August University, Göttingen, Germany

Marco Barbero

Role: PRINCIPAL_INVESTIGATOR

University of Applied Sciences and Arts of Southern Switzerland (SUPSI), Manno, Switzerland

Aisling Brenan

Role: PRINCIPAL_INVESTIGATOR

Adelaide and Meath Hospital Dublin incorporating the National Children's Hospital (Tallaght Hospital), Dublin, Ireland

Locations

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

Dublin, , Ireland

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

Dublin, , Ireland

Physiotherapy Department, St. James's Hospital

Dublin, , Ireland

Countries

Ireland

Other Identifiers

UDublinTC 12

Identifier Type: -

Identifier Source: org_study_id