The Nor-Hand Study: An Observational Cohort of Hand Osteoarthritis Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 300
- 试验地点
- 1
- 主要终点
- CT
研究概览
简要总结
The Nor-Hand study is a hospital-based observational study including 300 patients with evidence of hand OA by ultrasound and/or clinical examination. The baseline examination (2016-17) consists of functional tests and joint assessment of the hands, medical assessment, pain sensitization tests, ultrasound (hands, acromioclavicular joint, hips, knees and feet), computer tomography (CT) and Magnetic Resonance Imaging (MRI) of the dominant hand, conventional radiographs of the hands and feet, fluorescence optical imaging of the hands, collection of blood and urine samples as well as self-reported demographic factors and OA-related questionnaires. Two follow-up examinations are planned after 3 (2019-20) and 8 years (2024-25), respectively. Cross-sectional analyses will be used to investigate agreements and associations between different relevant measures at the baseline examination, whereas the longitudinal data will be used for evaluation of predictors for clinical outcomes and disease progression.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 40 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 40-70 years at screening
- •Proven hand OA by clinical examination and/or ultrasound
- •Clinical examination criteria: Heberden/Bouchards nodes and/or bony enlargement, squaring and/or deformity of the thumb base and no clinical signs of inflammatory arthritis (e.g. soft tissue swelling of two or less metacarpophalangeal (MCP) joints, and no soft tissue swelling of the wrist).
- •Ultrasound criteria: Osteophytes in the interphalangeal joints and/or the thumb base, and no signs of inflammatory arthritis (e.g. synovitis with power Doppler activity in two or less MCP joints and no synovitis with power Doppler activity in the wrist).
- •Capable of understanding and signing an informed consent form
- •Provided a written informed consent to participate in the study
排除标准
- •Diagnosis of inflammatory arthritic disease, e.g. seropositive or seronegative rheumatoid arthritis, psoriatic arthritis, reactive arthritis, spondyloarthritis or arthritis related to connective tissue disorders
- •Diagnosis of psoriasis
- •Erythrocyte sedimentation rate (ESR) > 40 mm/hour and/or C-reactive protein (CRP) >20 mg/L, without a known ongoing infection
- •Anti Cyclic Citrullinated Protein (anti-CCP) and/or rheumatoid factor positivity
- •Ferritin >200 microgram/L for women and >300 microgram/L for men and s-iron/s-total iron binding capacity (TIBC) above 50%
- •Major co-morbidities (e.g. severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease or severe respiratory disease)
- •Mental or psychiatric disorders, alcohol or drug abuse, language difficulties or other factors that make compliance to the study protocol difficult.
结局指标
主要结局
CT
时间窗: Baseline
CT of dominant hand
Biobank
时间窗: 3 year follow-up
Collection of whole blood, serum, plasma and urine
Sleep disturbances
时间窗: 3 year follow-up
Self-reported sleep disturbances
Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP)
时间窗: Baseline
Modified version to assess constant and intermittent pain in patients with hand OA (self-reported)
Foot Function Index
时间窗: 3 year follow-up
Self-reported pain in feet, disability, activity restrictions
Use of shoewear
时间窗: 3 year follow-up
The use of shoes with varying type of forefoot and heels
Pain Sensitivity Questionnaire
时间窗: 3 year follow-up
Pain in different daily-life situations, normally leading to no or little pain
40 m walking test
时间窗: 3 year follow-up
Time in sec for 40 m walking
Global health assessment
时间窗: 3 year follow-up
The evaluation of the global health on Visual analogue scale (VAS)
Short form 12 Energy
时间窗: 3 year follow-up
One question from Short form 12 about poor energy
Brief Illness Perception Questionnaire
时间窗: 3 year follow-up
Illness perception related to their hand OA disease and symptoms
Demographic factors
时间窗: 3 year follow-up
Self-reported relationship status, social network, education, employment
Michigan Hand Outcomes Questionnaire (MHOQ)
时间窗: 3 year follow-up
All subscales
Localization of joint pain (homonculus)
时间窗: 3 year follow-up
Self-reported pain during the last 24 hours and previous 6 weeks
Self-reported joint pain, hand pain, feet pain, fatigue, disease activity
时间窗: 3 year follow-up
Numeric Rating Scale (0-10)
Western Ontario and McMaster Universities Arthrtis Index (WOMAC)
时间窗: 3 year follow-up
Self-reported knee/hip pain, stiffness and physical function
Heart rate
时间窗: 3 year follow-up
Examination heart rate after rest (performed by medical student)
Comorbidity questionnaires and medications
时间窗: 3 year follow-up
Self-reported comorbidities and medications
Hair sample
时间窗: Baseline
Small hair sample is collected from the back of the patients´ head for quantification of cortisol
Pain sensitization tests
时间窗: 3 year follow-up
Temporal summation, pressure pain threshold (painful finger joint, non-painful finger joint, trapezius muscle, left distal radioulnar joint and tibialis anterior muscle), conditioned pain modulation, light touch
Ultrasound examination
时间窗: 3 year follow-up
Osteophytes, grey-scale synovitis and power doppler activity in hands, AC joint, hips, knees and feet
MRI
时间窗: 3 year follow-up
MRI of dominant hand
Life style factors
时间窗: 3 year follow-up
Self-reported physical activity, smoking, use of alcohol (AUDIT-C)
Pain catastrophizing scale
时间窗: 3 year follow-up
Self-reported magnification, rumination, helplessness
Grip strength
时间窗: 3 year follow-up
Bilateral measurement of grip strength using Jamar dynamometer
EuroQol 5 dimensions
时间窗: 3 year follow-up
Self-reported mobility, self-care, usual activity, pain/discomfort, anxiety/depression
Australian/Canadian hand index (AUSCAN)
时间窗: 3 year follow-up
Self-reported hand pain, stiffness and physical function
Clinical disease variables
时间窗: 3 year follow-up
Previous injuries of hand/foot, use of medications, previous steroid injections, use of hand orthoses, use of customized tools, previous surgeries, use of alternative therapies, use of supplements, use of nature cures, use of self-help techniques
PainDetect
时间窗: 3 year follow-up
Modified version to assess neuropathic hand pain (self-reported)
McGill Questionnaire
时间窗: Baseline
Modified version to assess hand OA pain characteristics (self-reported)
Self-efficacy scales
时间窗: 3 year follow-up
Self-reported ability influence pain and symptoms
Height
时间窗: 3 year follow-up
Examination of height in standing position (performed by medical student)
Joint assessment (examination by rheumatologist)
时间窗: 3 year follow-up
Bony enlargement, tenderness (Doyle index in hand) and soft tissue swelling in hands and feet, and assessment of the ACR criteria of hand, knee and hip
Fluorescence Optical Imaging
时间窗: 3 year follow-up
Examination of altered microcirculation in the hands
Conventional radiographs
时间窗: 3 year follow-up
Hands (frontal), feet (frontal, oblique and side images)
Brief Approach/Avoidance Coping Questionnaire (BACQ)
时间窗: Baseline
Self-reported approach-oriented and avoidance oriented coping
Hormonal factors in women
时间窗: 3 year follow-up
Menarche, menopause, gynecological operations, hormone treatment, pregnancies, breastfeeding
Fibromyalgia symptoms
时间窗: 3 year follow-up
ACR criteria for fibromyalgia
Weight
时间窗: 3 year follow-up
Examination of weight in light-weighted clothes (performed by medical student)
Hip/waist circumference
时间窗: 3 year follow-up
Examination of hip and waist circumference (performed by medical student)
Blood pressure
时间窗: 3 year follow-up
Examination of blood pressure after rest (performed by medical student)
Moberg Pick-Up test
时间窗: 3 year follow-up
Bilateral measurement of fine motor acitivities (time to pick up small elements and put in the box)
Chair Stand test
时间窗: 3 year follow-up
Number of chair stands during 30 sec
次要结局
未报告次要终点
研究者
Ida Kristin Haugen
MD, PhD
Diakonhjemmet Hospital