Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
300 participants
OBSERVATIONAL
2016-04-30
2021-05-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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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.
Imaging
Conventional radiographs (hands/feet), CT of dominant hand, MRI of dominant hand, ultrasound (hands/shoulder/feet/hips/knees), fluorescence optical imaging of hands
Physical examinations
Joint assessment of hands and feet, pain sensitization test and functional tests
Questionnnaires
Self-reported demographic factors, clinical variables and OA history and symptoms
Interventions
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Imaging
Conventional radiographs (hands/feet), CT of dominant hand, MRI of dominant hand, ultrasound (hands/shoulder/feet/hips/knees), fluorescence optical imaging of hands
Physical examinations
Joint assessment of hands and feet, pain sensitization test and functional tests
Questionnnaires
Self-reported demographic factors, clinical variables and OA history and symptoms
Eligibility Criteria
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Inclusion Criteria
* Proven hand OA by clinical examination and/or ultrasound
1. 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).
2. 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 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.
40 Years
70 Years
ALL
No
Sponsors
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Diakonhjemmet Hospital
OTHER
Responsible Party
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Ida Kristin Haugen
MD, PhD
Principal Investigators
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Ida K Haugen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Diakonhjemmet Hospital
Locations
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Diakonhjemmet Hospital
Oslo, , Norway
Countries
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References
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Fjellstad CM, Mathiessen A, Slatkowsky-Christensen B, Kvien TK, Hammer HB, Haugen IK. Associations Between Ultrasound-Detected Synovitis, Pain, and Function in Interphalangeal and Thumb Base Osteoarthritis: Data From the Nor-Hand Cohort. Arthritis Care Res (Hoboken). 2020 Nov;72(11):1530-1535. doi: 10.1002/acr.24047.
Gloersen M, Steen Pettersen P, Kvien TK, Haugen IK. Validation of the Intermittent and Constant Osteoarthritis Pain Questionnaire in Patients with Hand Osteoarthritis: Results from the Nor-Hand Study. J Rheumatol. 2019 Jun;46(6):645-651. doi: 10.3899/jrheum.180835. Epub 2019 Mar 15.
Steen Pettersen P, Neogi T, Magnusson K, Berner Hammer H, Uhlig T, Kvien TK, Haugen IK. Peripheral and Central Sensitization of Pain in Individuals With Hand Osteoarthritis and Associations With Self-Reported Pain Severity. Arthritis Rheumatol. 2019 Jul;71(7):1070-1077. doi: 10.1002/art.40850. Epub 2019 May 14.
Gloersen M, Mulrooney E, Mathiessen A, Hammer HB, Slatkowsky-Christensen B, Faraj K, Isaksen T, Neogi T, Kvien TK, Magnusson K, Haugen IK. A hospital-based observational cohort study exploring pain and biomarkers in patients with hand osteoarthritis in Norway: The Nor-Hand protocol. BMJ Open. 2017 Sep 24;7(9):e016938. doi: 10.1136/bmjopen-2017-016938.
Other Identifiers
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DIA2017-1
Identifier Type: -
Identifier Source: org_study_id
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