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

Study Overview
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Brief Summary
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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
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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.

Official Title
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Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain: An Exploration of Similarities and Differences

Conditions
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Back Pain, Spondylitis, Ankylosing, Low Back Pain

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ankylosing Spondylitis<br> | |
| Chronic non-specific low back pain<br> | |

What is the study measuring?
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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. | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Inflammatory back pain, Ankylosing spondylitis, Non-specific low back pain, Pain experience, Disability, Behavioural, Psychological, Biopsychosocial, Pain profiles