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Clinical Trials/NCT02704845
NCT02704845CompletedNot Applicable

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

University of Dublin, Trinity College3 sites in 1 country58 target enrollmentStarted: September 2015Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
58
Locations
3
Primary Endpoint
Back pain-related functional disability

Study Overview

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 Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

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
  • 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

Outcomes

Primary Outcomes

Back pain-related functional disability

Time Frame: Day 1, no follow-up will be required.

Oswestry Disability Index (ODI)

Back pain intensity - total

Time Frame: 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 Outcomes

  • Chest expansion(Day 1, no follow-up will be required.)
  • Grip strength(Day 1, no follow-up will be required.)
  • Functional performance and endurance(Day 1, no follow-up will be required.)
  • Pain-related fear, fear of movement/(re)injury(Day 1, no follow-up will be required.)
  • Flexibility and spinal mobility for AS patients(Day 1, no follow-up will be required.)
  • Self-efficacy for AS patients(Day 1, no follow-up will be required.)
  • Pain cognition and coping(Day 1, no follow-up will be required.)
  • Pain catastrophizing behavior(Day 1, no follow-up will be required.)
  • Psychological distress (depression & anxiety)(Day 1, no follow-up will be required.)
  • The extent and location of pain(Day 1, no follow-up will be required.)
  • Forward bending(Day 1, no follow-up will be required.)
  • Isometric endurance of the the trunk flexor muscles(Day 1, no follow-up will be required.)
  • Back pain beliefs(Day 1, no follow-up will be required.)
  • The fear-avoidance behaviours of physical activity(Day 1, no follow-up will be required.)
  • Back pain intensity - nocturnal(Day 1, no follow-up will be required.)
  • Disease activity for AS patients(Day 1, no follow-up will be required.)
  • Global well-being for AS patients(Day 1, no follow-up will be required.)
  • Functional performance(Day 1, no follow-up will be required.)
  • Physical function for AS patients(Day 1, no follow-up will be required.)
  • Isometric endurance of the trunk extensor muscles(Day 1, no follow-up will be required.)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lolwah Al-Rashed

Lead Investigator

University of Dublin, Trinity College

Study Sites (3)

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