Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain
2016년 10월 19일 업데이트: Lolwah Al-Rashed, University of Dublin, Trinity College
Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain: An Exploration of Similarities and Differences
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.
연구 개요
상세 설명
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.
연구 유형
관찰
등록 (실제)
58
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Dublin, 아일랜드, D24
- Physiotherapy Department, Adelaide and Meath Incorporating the National Children's Hospital (Tallaght Hospital)
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Dublin, 아일랜드, D8
- Ankylosing Spondylitis clinic, Rheumatology Department, St. James's Hospital
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Dublin, 아일랜드, D8
- Physiotherapy Department, St. James's Hospital
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
샘플링 방법
비확률 샘플
연구 인구
A convenience sample of adults with Ankylosing Spondylitis (AS) will be consecutively recruited from a pool of patients referred to AS clinic in the Rheumatology and Physiotherapy Departments of St. James's and Tallaght Hospitals in Dublin.
Adults with chronic non-specifi low back pain (CNSLBP) (control group) will be consecutively recruited from a pool of patients referred to the Physiotherapy Department of St. James's and Tallaght Hospitals in Dublin. An invitation to participate in the study and an information leaflet will be extended to the patients who potentially meet the recruitment criteria.
설명
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
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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강직성 척추염
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Chronic non-specific low back pain
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Back pain intensity - total
기간: Day 1, no follow-up will be required.
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The average total back pain intensity in the last week will be measured by the Numeric Rating Scale (NRS)
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Day 1, no follow-up will be required.
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Back pain-related functional disability
기간: Day 1, no follow-up will be required.
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Oswestry Disability Index (ODI)
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Day 1, no follow-up will be required.
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Back pain beliefs
기간: Day 1, no follow-up will be required.
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Back Beliefs Questionnaire (BBQ)
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Day 1, no follow-up will be required.
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Pain-related fear, fear of movement/(re)injury
기간: Day 1, no follow-up will be required.
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Tampa Scale for Kinesiophobia (TSK)
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Day 1, no follow-up will be required.
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The fear-avoidance behaviours of physical activity
기간: Day 1, no follow-up will be required.
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modified Fear Avoidance Behaviour Questionnaire (mFABQ)
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Day 1, no follow-up will be required.
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Pain catastrophizing behavior
기간: Day 1, no follow-up will be required.
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Pain catastrophizing scale (PCS)
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Day 1, no follow-up will be required.
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Self-efficacy for AS patients
기간: Day 1, no follow-up will be required.
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Ankylosing Spondylitis-specific Arthritis Self-Efficacy Scale (ASES-AS)
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Day 1, no follow-up will be required.
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Pain cognition and coping
기간: Day 1, no follow-up will be required.
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Pain Coping Inventory (PCI)
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Day 1, no follow-up will be required.
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Psychological distress (depression & anxiety)
기간: Day 1, no follow-up will be required.
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Hospital Anxiety and Depression Scale (HADS)
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Day 1, no follow-up will be required.
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The extent and location of pain
기간: Day 1, no follow-up will be required.
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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)
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Day 1, no follow-up will be required.
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Back pain intensity - nocturnal
기간: Day 1, no follow-up will be required.
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The average nocturnal back pain intensity in the last week will be measured by the Numeric Rating Scale (NRS)
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Day 1, no follow-up will be required.
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Physical function for AS patients
기간: Day 1, no follow-up will be required.
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Bath Ankylosing Spondylitis Functional Index (BASFI)
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Day 1, no follow-up will be required.
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Disease activity for AS patients
기간: Day 1, no follow-up will be required.
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Bath Ankylosing Spondylitis Disease Activity Index (BASDAI)
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Day 1, no follow-up will be required.
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Disease activity for AS patients
기간: Day 1, no follow-up will be required.
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Ankylosing Spondylitis Disease Activity Score (ASDAS)
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Day 1, no follow-up will be required.
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Global well-being for AS patients
기간: Day 1, no follow-up will be required.
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Bath Ankylosing Spondylitis Global score (BAS-G)
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Day 1, no follow-up will be required.
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Flexibility and spinal mobility for AS patients
기간: Day 1, no follow-up will be required.
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Bath Ankylosing Spondylitis Metrology Index (BASMI)
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Day 1, no follow-up will be required.
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Chest expansion
기간: Day 1, no follow-up will be required.
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Chest expansion will be measured circumferentially using a tape measure
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Day 1, no follow-up will be required.
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Forward bending
기간: Day 1, no follow-up will be required.
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Finger-to-Floor Distance in centimetres (cm) will be measured using a tape measure
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Day 1, no follow-up will be required.
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Isometric endurance of the trunk extensor muscles
기간: Day 1, no follow-up will be required.
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Ito test
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Day 1, no follow-up will be required.
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Isometric endurance of the the trunk flexor muscles
기간: Day 1, no follow-up will be required.
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Shirado test
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Day 1, no follow-up will be required.
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Grip strength
기간: Day 1, no follow-up will be required.
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Hand grip dynamometer (Jamar Hydraulic Hand Dynamometer)
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Day 1, no follow-up will be required.
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Functional performance
기간: Day 1, no follow-up will be required.
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50-foot walk test
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Day 1, no follow-up will be required.
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Functional performance and endurance
기간: Day 1, no follow-up will be required.
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6-min walk distance (6MWD) test
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Day 1, no follow-up will be required.
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Fiona Wilson, Trinity College Dublin, Ireland
- 수석 연구원: Lolwah A Al-Rashed, Trinity College Dublin, Ireland
- 수석 연구원: Finbar O'Shea, St. James's Hospital, Dublin, Ireland
- 수석 연구원: Deborah Falla, University Medical Center Göttingen, Georg-August University, Göttingen, Germany
- 수석 연구원: Marco Barbero, University of Applied Sciences and Arts of Southern Switzerland (SUPSI), Manno, Switzerland
- 수석 연구원: Aisling Brenan, Adelaide and Meath Hospital Dublin incorporating the National Children's Hospital (Tallaght Hospital), Dublin, Ireland
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2015년 9월 1일
기본 완료 (실제)
2016년 8월 1일
연구 완료 (실제)
2016년 8월 1일
연구 등록 날짜
최초 제출
2016년 2월 27일
QC 기준을 충족하는 최초 제출
2016년 3월 4일
처음 게시됨 (추정)
2016년 3월 10일
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
2016년 10월 21일
QC 기준을 충족하는 마지막 업데이트 제출
2016년 10월 19일
마지막으로 확인됨
2016년 10월 1일
추가 정보
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