The Nor-Hand Study
Study Details
Study Description
Brief Summary
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Hand osteoarthritis 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
Conventional radiographs (hands/feet), CT of dominant hand, MRI of dominant hand, ultrasound (hands/shoulder/feet/hips/knees), fluorescence optical imaging of hands
Diagnostic Test: Physical examinations
Joint assessment of hands and feet, pain sensitization test and functional tests
Diagnostic Test: Questionnnaires
Self-reported demographic factors, clinical variables and OA history and symptoms
|
Outcome Measures
Primary Outcome Measures
- Demographic factors [Baseline]
Self-reported relationship status, education, employment, hand tasks in work/previous work, birth place
- Demographic factors [3 year follow-up]
Self-reported relationship status, social network, education, employment
- Life style factors [Baseline]
Self-reported physical activity, smoking, use of alcohol (AUDIT-C)
- Life style factors [3 year follow-up]
Self-reported physical activity, smoking, use of alcohol (AUDIT-C)
- Clinical disease variables [Baseline]
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
- Clinical disease variables [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
- EuroQol 5 dimensions [Baseline]
Self-reported mobility, self-care, usual activity, pain/discomfort, anxiety/depression
- EuroQol 5 dimensions [3 year follow-up]
Self-reported mobility, self-care, usual activity, pain/discomfort, anxiety/depression
- Sleep disturbances [Baseline]
Self-reported sleep disturbances
- Sleep disturbances [3 year follow-up]
Self-reported sleep disturbances
- Michigan Hand Outcomes Questionnaire (MHOQ) [Baseline]
Aesthetic damage subscale
- Michigan Hand Outcomes Questionnaire (MHOQ) [3 year follow-up]
All subscales
- Localization of joint pain (homonculus) [Baseline]
Self-reported pain during the last 24 hours and previous 6 weeks
- Localization of joint pain (homonculus) [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 [Baseline]
Numeric Rating Scale (0-10)
- Self-reported joint pain, hand pain, feet pain, fatigue, disease activity [3 year follow-up]
Numeric Rating Scale (0-10)
- Australian/Canadian hand index (AUSCAN) [Baseline]
Self-reported hand pain, stiffness and physical function
- Australian/Canadian hand index (AUSCAN) [3 year follow-up]
Self-reported hand pain, stiffness and physical function
- Western Ontario and McMaster Universities Arthrtis Index (WOMAC) [Baseline]
Self-reported knee/hip pain, stiffness and physical function
- Western Ontario and McMaster Universities Arthrtis Index (WOMAC) [3 year follow-up]
Self-reported knee/hip pain, stiffness and physical function
- Measure of Intermittent and Constant Osteoarthritis Pain (ICOAP) [Baseline]
Modified version to assess constant and intermittent pain in patients with hand OA (self-reported)
- McGill Questionnaire [Baseline]
Modified version to assess hand OA pain characteristics (self-reported)
- PainDetect [Baseline]
Modified version to assess neuropathic hand pain (self-reported)
- PainDetect [3 year follow-up]
Modified version to assess neuropathic hand pain (self-reported)
- Brief Approach/Avoidance Coping Questionnaire (BACQ) [Baseline]
Self-reported approach-oriented and avoidance oriented coping
- Pain catastrophizing scale [Baseline]
Self-reported magnification, rumination, helplessness
- Pain catastrophizing scale [3 year follow-up]
Self-reported magnification, rumination, helplessness
- Self-efficacy scales [Baseline]
Self-reported ability influence pain and symptoms
- Self-efficacy scales [3 year follow-up]
Self-reported ability influence pain and symptoms
- Foot Function Index [Baseline]
Self-reported pain in feet, disability, activity restrictions
- Foot Function Index [3 year follow-up]
Self-reported pain in feet, disability, activity restrictions
- Hormonal factors in women [Baseline]
Menopause
- Hormonal factors in women [3 year follow-up]
Menarche, menopause, gynecological operations, hormone treatment, pregnancies, breastfeeding
- Use of shoewear [3 year follow-up]
The use of shoes with varying type of forefoot and heels
- Global health assessment [3 year follow-up]
The evaluation of the global health on Visual analogue scale (VAS)
- Pain Sensitivity Questionnaire [3 year follow-up]
Pain in different daily-life situations, normally leading to no or little pain
- Fibromyalgia symptoms [3 year follow-up]
ACR criteria for fibromyalgia
- Short form 12 Energy [3 year follow-up]
One question from Short form 12 about poor energy
- Brief Illness Perception Questionnaire [3 year follow-up]
Illness perception related to their hand OA disease and symptoms
- Height [Baseline]
Examination of height in standing position (performed by medical student)
- Height [3 year follow-up]
Examination of height in standing position (performed by medical student)
- Weight [Baseline]
Examination of weight in light-weighted clothes (performed by medical student)
- Weight [3 year follow-up]
Examination of weight in light-weighted clothes (performed by medical student)
- Hip/waist circumference [Baseline]
Examination of hip and waist circumference (performed by medical student)
- Hip/waist circumference [3 year follow-up]
Examination of hip and waist circumference (performed by medical student)
- Blood pressure [Baseline]
Examination of blood pressure after rest (performed by medical student)
- Blood pressure [3 year follow-up]
Examination of blood pressure after rest (performed by medical student)
- Heart rate [Baseline]
Examination heart rate after rest (performed by medical student)
- Heart rate [3 year follow-up]
Examination heart rate after rest (performed by medical student)
- Comorbidity questionnaires and medications [Baseline]
Self-reported comorbidities and medications
- Comorbidity questionnaires and medications [3 year follow-up]
Self-reported comorbidities and medications
- Hair sample [Baseline]
Small hair sample is collected from the back of the patients´ head for quantification of cortisol
- Joint assessment (examination by rheumatologist) [Baseline]
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
- Joint assessment (examination by rheumatologist) [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
- Grip strength [Baseline, follow-up]
Bilateral measurement of grip strength using Jamar dynamometer
- Grip strength [3 year follow-up]
Bilateral measurement of grip strength using Jamar dynamometer
- Moberg Pick-Up test [Baseline]
Bilateral measurement of fine motor acitivities (time to pick up small elements and put in the box)
- Moberg Pick-Up test [3 year follow-up]
Bilateral measurement of fine motor acitivities (time to pick up small elements and put in the box)
- Chair Stand test [3 year follow-up]
Number of chair stands during 30 sec
- 40 m walking test [3 year follow-up]
Time in sec for 40 m walking
- Pain sensitization tests [Baseline]
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
- Pain sensitization tests [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 [Baseline]
Osteophytes, grey-scale synovitis and power doppler activity in hands, AC joint, hips, knees and feet
- Ultrasound examination [3 year follow-up]
Osteophytes, grey-scale synovitis and power doppler activity in hands, AC joint, hips, knees and feet
- Fluorescence Optical Imaging [Baseline]
Examination of altered microcirculation in the hands
- Fluorescence Optical Imaging [3 year follow-up]
Examination of altered microcirculation in the hands
- Conventional radiographs [Baseline]
Hands (frontal), feet (frontal, oblique and side images)
- Conventional radiographs [3 year follow-up]
Hands (frontal), feet (frontal, oblique and side images)
- MRI [Baseline]
MRI of dominant hand
- MRI [3 year follow-up]
MRI of dominant hand
- CT [Baseline]
CT of dominant hand
- Biobank [Baseline]
Collection of whole blood, serum, plasma and urine
- Biobank [3 year follow-up]
Collection of whole blood, serum, plasma and urine
Eligibility Criteria
Criteria
Inclusion Criteria:
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Age between 40-70 years at screening
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Proven hand OA by clinical examination and/or ultrasound
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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).
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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).
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Capable of understanding and signing an informed consent form
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Provided a written informed consent to participate in the study
Exclusion Criteria:
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Diagnosis of inflammatory arthritic disease, e.g. seropositive or seronegative rheumatoid arthritis, psoriatic arthritis, reactive arthritis, spondyloarthritis or arthritis related to connective tissue disorders
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Diagnosis of psoriasis
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Erythrocyte sedimentation rate (ESR) > 40 mm/hour and/or C-reactive protein (CRP) >20 mg/L, without a known ongoing infection
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Anti Cyclic Citrullinated Protein (anti-CCP) and/or rheumatoid factor positivity
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Ferritin >200 microgram/L for women and >300 microgram/L for men and s-iron/s-total iron binding capacity (TIBC) above 50%
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Major co-morbidities (e.g. severe malignancies, severe diabetes mellitus, severe infections, uncontrollable hypertension, severe cardiovascular disease or severe respiratory disease)
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Mental or psychiatric disorders, alcohol or drug abuse, language difficulties or other factors that make compliance to the study protocol difficult.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Diakonhjemmet Hospital | Oslo | Norway |
Sponsors and Collaborators
- Diakonhjemmet Hospital
Investigators
- Principal Investigator: Ida K Haugen, MD, PhD, Diakonhjemmet Hospital
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- DIA2017-1