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

Low Back Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02704845
• Other study ID #: UDublinTC 12
• Status: Completed
• Phase: N/A
• First received: February 27, 2016
• Last updated: October 19, 2016
• Start date: September 2015
• Est. completion date: August 2016

Study information

• Verified date: October 2016
• Source: University of Dublin, Trinity College
• Contact: n/a
• Is FDA regulated: No
• Health authority: Ireland: Research Ethics Committee
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 58
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain
• Spondylitis
• Spondylitis, Ankylosing

Locations

Country	Name	City	State
Ireland	Ankylosing Spondylitis clinic, Rheumatology Department, St. James's Hospital	Dublin
Ireland	Physiotherapy Department, Adelaide and Meath Incorporating the National Children's Hospital (Tallaght Hospital)	Dublin
Ireland	Physiotherapy Department, St. James's Hospital	Dublin

Sponsors (1)

Lead Sponsor	Collaborator
University of Dublin, Trinity College

Country where clinical trial is conducted

Ireland, 

Outcome

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