The Nor-Hand Study

Study Overview
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Brief Summary
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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.

Official Title
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The Nor-Hand Study: An Observational Cohort of Hand Osteoarthritis Patients

Conditions
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Osteoarthritis, Pain, Inflammation, Image, Body

Intervention / Treatment
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* Diagnostic Test: Imaging
* Diagnostic Test: Physical examinations
* Diagnostic Test: Questionnnaires


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Hand osteoarthritis<br>Men and women (40-70 years) with a diagnosis of hand OA based on clinical or ultrasound examination are included. Patients with systemic inflammatory joint diseases, psoriasis and hemochromatosis are excluded. | Diagnostic Test: Imaging<br>* Conventional radiographs (hands/feet), CT of dominant hand, MRI of dominant hand, ultrasound (hands/shoulder/feet/hips/knees), fluorescence optical imaging of hands<br>Diagnostic Test: Physical examinations<br>* Joint assessment of hands and feet, pain sensitization test and functional tests<br>Diagnostic Test: Questionnnaires<br>* Self-reported demographic factors, clinical variables and OA history and symptoms<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demographic factors | Self-reported relationship status, education, employment, hand tasks in work/previous work, birth place | Baseline | 
| Demographic factors | Self-reported relationship status, social network, education, employment | 3 year follow-up | 
| Life style factors | Self-reported physical activity, smoking, use of alcohol (AUDIT-C) | Baseline | 
| Life style factors | Self-reported physical activity, smoking, use of alcohol (AUDIT-C) | 3 year follow-up | 
| Clinical disease variables | Self-reported year diagnosed with OA, number of years with OA symptoms, OA in family, 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 | Baseline | 
| Clinical disease variables | 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 | 3 year follow-up | 
| EuroQol 5 dimensions | Self-reported mobility, self-care, usual activity, pain/discomfort, anxiety/depression | Baseline | 
| EuroQol 5 dimensions | Self-reported mobility, self-care, usual activity, pain/discomfort, anxiety/depression | 3 year follow-up | 
| Sleep disturbances | Self-reported sleep disturbances | Baseline | 
| Sleep disturbances | Self-reported sleep disturbances | 3 year follow-up | 
| Michigan Hand Outcomes Questionnaire (MHOQ) | Aesthetic damage subscale | Baseline | 
| Michigan Hand Outcomes Questionnaire (MHOQ) | All subscales | 3 year follow-up | 
| Localization of joint pain (homonculus) | Self-reported pain during the last 24 hours and previous 6 weeks | Baseline | 
| Localization of joint pain (homonculus) | Self-reported pain during the last 24 hours and previous 6 weeks | 3 year follow-up | 
| Self-reported joint pain, hand pain, feet pain, fatigue, disease activity | Numeric Rating Scale (0-10) | Baseline | 
| Self-reported joint pain, hand pain, feet pain, fatigue, disease activity | Numeric Rating Scale (0-10) | 3 year follow-up | 
| Australian/Canadian hand index (AUSCAN) | Self-reported hand pain, stiffness and physical function | Baseline | 
| Australian/Canadian hand index (AUSCAN) | Self-reported hand pain, stiffness and physical function | 3 year follow-up | 
| Western Ontario and McMaster Universities Arthrtis Index (WOMAC) | Self-reported knee/hip pain, stiffness and physical function | Baseline | 
| Western Ontario and McMaster Universities Arthrtis Index (WOMAC) | Self-reported knee/hip pain, stiffness and physical function | 3 year follow-up | 
| Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) | Modified version to assess constant and intermittent pain in patients with hand OA (self-reported) | Baseline | 
| McGill Questionnaire | Modified version to assess hand OA pain characteristics (self-reported) | Baseline | 
| PainDetect | Modified version to assess neuropathic hand pain (self-reported) | Baseline | 
| PainDetect | Modified version to assess neuropathic hand pain (self-reported) | 3 year follow-up | 
| Brief Approach/Avoidance Coping Questionnaire (BACQ) | Self-reported approach-oriented and avoidance oriented coping | Baseline | 
| Pain catastrophizing scale | Self-reported magnification, rumination, helplessness | Baseline | 
| Pain catastrophizing scale | Self-reported magnification, rumination, helplessness | 3 year follow-up | 
| Self-efficacy scales | Self-reported ability influence pain and symptoms | Baseline | 
| Self-efficacy scales | Self-reported ability influence pain and symptoms | 3 year follow-up | 
| Foot Function Index | Self-reported pain in feet, disability, activity restrictions | Baseline | 
| Foot Function Index | Self-reported pain in feet, disability, activity restrictions | 3 year follow-up | 
| Hormonal factors in women | Menopause | Baseline | 
| Hormonal factors in women | Menarche, menopause, gynecological operations, hormone treatment, pregnancies, breastfeeding | 3 year follow-up | 
| Use of shoewear | The use of shoes with varying type of forefoot and heels | 3 year follow-up | 
| Global health assessment | The evaluation of the global health on Visual analogue scale (VAS) | 3 year follow-up | 
| Pain Sensitivity Questionnaire | Pain in different daily-life situations, normally leading to no or little pain | 3 year follow-up | 
| Fibromyalgia symptoms | ACR criteria for fibromyalgia | 3 year follow-up | 
| Short form 12 Energy | One question from Short form 12 about poor energy | 3 year follow-up | 
| Brief Illness Perception Questionnaire | Illness perception related to their hand OA disease and symptoms | 3 year follow-up | 
| Height | Examination of height in standing position (performed by medical student) | Baseline | 
| Height | Examination of height in standing position (performed by medical student) | 3 year follow-up | 
| Weight | Examination of weight in light-weighted clothes (performed by medical student) | Baseline | 
| Weight | Examination of weight in light-weighted clothes (performed by medical student) | 3 year follow-up | 
| Hip/waist circumference | Examination of hip and waist circumference (performed by medical student) | Baseline | 
| Hip/waist circumference | Examination of hip and waist circumference (performed by medical student) | 3 year follow-up | 
| Blood pressure | Examination of blood pressure after rest (performed by medical student) | Baseline | 
| Blood pressure | Examination of blood pressure after rest (performed by medical student) | 3 year follow-up | 
| Heart rate | Examination heart rate after rest (performed by medical student) | Baseline | 
| Heart rate | Examination heart rate after rest (performed by medical student) | 3 year follow-up | 
| Comorbidity questionnaires and medications | Self-reported comorbidities and medications | Baseline | 
| Comorbidity questionnaires and medications | Self-reported comorbidities and medications | 3 year follow-up | 
| Hair sample | Small hair sample is collected from the back of the patients´ head for quantification of cortisol | Baseline | 
| Joint assessment (examination by rheumatologist) | 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 | Baseline | 
| Joint assessment (examination by rheumatologist) | 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 | 3 year follow-up | 
| Grip strength | Bilateral measurement of grip strength using Jamar dynamometer | Baseline, follow-up | 
| Grip strength | Bilateral measurement of grip strength using Jamar dynamometer | 3 year follow-up | 
| Moberg Pick-Up test | Bilateral measurement of fine motor acitivities (time to pick up small elements and put in the box) | Baseline | 
| Moberg Pick-Up test | Bilateral measurement of fine motor acitivities (time to pick up small elements and put in the box) | 3 year follow-up | 
| Chair Stand test | Number of chair stands during 30 sec | 3 year follow-up | 
| 40 m walking test | Time in sec for 40 m walking | 3 year follow-up | 
| Pain sensitization tests | 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 | Baseline | 
| Pain sensitization tests | 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 | 3 year follow-up | 
| Ultrasound examination | Osteophytes, grey-scale synovitis and power doppler activity in hands, AC joint, hips, knees and feet | Baseline | 
| Ultrasound examination | Osteophytes, grey-scale synovitis and power doppler activity in hands, AC joint, hips, knees and feet | 3 year follow-up | 
| Fluorescence Optical Imaging | Examination of altered microcirculation in the hands | Baseline | 
| Fluorescence Optical Imaging | Examination of altered microcirculation in the hands | 3 year follow-up | 
| Conventional radiographs | Hands (frontal), feet (frontal, oblique and side images) | Baseline | 
| Conventional radiographs | Hands (frontal), feet (frontal, oblique and side images) | 3 year follow-up | 
| MRI | MRI of dominant hand | Baseline | 
| MRI | MRI of dominant hand | 3 year follow-up | 
| CT | CT of dominant hand | Baseline | 
| Biobank | Collection of whole blood, serum, plasma and urine | Baseline | 
| Biobank | Collection of whole blood, serum, plasma and urine | 3 year follow-up |