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

Completed

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

• Registration Number: NCT02704845
• Lead Sponsor: University of Dublin, Trinity College

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.

Study Timeline

• Study Start: 2015-09
• Study First Submitted: 2016-02-27
• Study First Submitted QC: 2016-03-04
• Study First Posted: 2016-03-10
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-19
• Last Update Posted: 2016-10-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 58

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

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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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Back pain-related functional disability	Day 1, no follow-up will be required.	Oswestry Disability Index (ODI)
Back pain intensity - total	Day 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)

Secondary Outcome Measures

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

Trial Locations

Locations (3)

Physiotherapy Department, Adelaide and Meath Incorporating the National Children's Hospital (Tallaght Hospital); 🇮🇪 Dublin, Ireland

Physiotherapy Department, St. James's Hospital; 🇮🇪 Dublin, Ireland

Ankylosing Spondylitis clinic, Rheumatology Department, St. James's Hospital; 🇮🇪 Dublin, Ireland