Biopsychosocial Exploration of Pain Profiles in Inflammatory and Chronic Non-specific Axial Low Back Pain
2016年10月19日 更新者：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.
調査の概要
詳細な説明
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.
研究の種類
観察的
入学 (実際)
58
連絡先と場所
このセクションには、調査を実施する担当者の連絡先の詳細と、この調査が実施されている場所に関する情報が記載されています。
研究場所
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Dublin、アイルランド、D24
- Physiotherapy Department, Adelaide and Meath Incorporating the National Children's Hospital (Tallaght Hospital)
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Dublin、アイルランド、D8
- Ankylosing Spondylitis clinic, Rheumatology Department, St. James's Hospital
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Dublin、アイルランド、D8
- Physiotherapy Department, St. James's Hospital
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参加基準
研究者は、適格基準と呼ばれる特定の説明に適合する人を探します。これらの基準のいくつかの例は、人の一般的な健康状態または以前の治療です。
適格基準
就学可能な年齢
18年～65年 (大人、高齢者)
健康ボランティアの受け入れ
いいえ
受講資格のある性別
全て
サンプリング方法
非確率サンプル
調査対象母集団
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.
説明
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
研究計画
このセクションでは、研究がどのように設計され、研究が何を測定しているかなど、研究計画の詳細を提供します。
研究はどのように設計されていますか？
デザインの詳細
コホートと介入
グループ/コホート |
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強直性脊椎炎
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Chronic non-specific low back pain
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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Back pain intensity - total
時間枠：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
時間枠：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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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Back pain beliefs
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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)
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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
時間枠：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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協力者と研究者
ここでは、この調査に関係する人々や組織を見つけることができます。
捜査官
- 主任研究者：Fiona Wilson、Trinity College Dublin, Ireland
- 主任研究者：Lolwah A Al-Rashed、Trinity College Dublin, Ireland
- 主任研究者：Finbar O'Shea、St. James's Hospital, Dublin, Ireland
- 主任研究者：Deborah Falla、University Medical Center Göttingen, Georg-August University, Göttingen, Germany
- 主任研究者：Marco Barbero、University of Applied Sciences and Arts of Southern Switzerland (SUPSI), Manno, Switzerland
- 主任研究者：Aisling Brenan、Adelaide and Meath Hospital Dublin incorporating the National Children's Hospital (Tallaght Hospital), Dublin, Ireland
研究記録日
これらの日付は、ClinicalTrials.gov への研究記録と要約結果の提出の進捗状況を追跡します。研究記録と報告された結果は、国立医学図書館 (NLM) によって審査され、公開 Web サイトに掲載される前に、特定の品質管理基準を満たしていることが確認されます。
主要日程の研究
研究開始
2015年9月1日
一次修了 (実際)
2016年8月1日
研究の完了 (実際)
2016年8月1日
試験登録日
最初に提出
2016年2月27日
QC基準を満たした最初の提出物
2016年3月4日
最初の投稿 (見積もり)
2016年3月10日
学習記録の更新
投稿された最後の更新 (見積もり)
2016年10月21日
QC基準を満たした最後の更新が送信されました
2016年10月19日
最終確認日
2016年10月1日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。