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ISRCTN
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ISRCTN68990076
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ClinicalTrials.gov identifier
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Public title
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Randomised controlled trial for the treatment of hand arthrosis with prednisolone and naproxen
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Scientific title
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Acronym
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BELIOA2
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Serial number at source
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IDS 04-05
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Study hypothesis
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The primary hypothesis is that patients with hand arthrosis treated with prednisolone for one week (3 days 50 mg, 4 days 25 mg) will improve significantly in different clinical parameters
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Lay summary
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Ethics approval
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The study was approved by the Internal Review Board and Ethical Committee of the Vienna Medical University on 14/02/2006, reference number 481/2005
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Study design
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Single-centre, randomised, double-blind, placebo-controlled clinical trial
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Countries of recruitment
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Austria
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Disease/condition/study domain
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Hand arthrosis
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Participants - inclusion criteria
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1. Hand arthrosis
2. Age over 18 years
3. Pain on a 100 mm Visual Analogue Scale (VAS) in the target hand more than 40 mm
4. Willingness to comply with the protocol
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Participants - exclusion criteria
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1. Current treatment with steroids
2. Cardiac insufficiency
3. Infection
4. Uncontrolled hypertension
5. History of gastrointestinal bleeding
6. Diabetes mellitus
7. Allergy against study medication
8. Pregnancy
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Anticipated start date
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01/12/2005
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Anticipated end date
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01/12/2006
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Status of trial
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Completed |
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Patient information material
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Target number of participants
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246
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Interventions
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Patients are randomised to receive treatment with either prednisolone or naproxen or placebo
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Primary outcome measure(s)
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Pain in the target hand measured on a 100 mm VAS
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Secondary outcome measure(s)
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1. Morning stiffness
2. VAS for disease activity
3. Tender and swollen joint counts (inflammatory and bony swelling)
4. Functioning measured with:
a. Health Assessment Questionnaire (HAQ)
b. Score for Assessment and Quantification of Chronic Rheumatic Affections of the Hands (SACRAH)
c. Arthritis Impact Measurement Scales 2 - Short Form (AIMS2-SF)
d. Grip strength
e. Moberg picking-up test
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Sources of funding
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Vienna Medical University (Austria)
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Trial website
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Publications
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Contact name
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Prof
Josef
Smolen
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Address
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Department of Internal Medicine III
Division of Rheumatology
Wahringer Gurtel 18-20
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City/town
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Vienna
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Zip/Postcode
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A-1090
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Country
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Austria
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Tel
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+43 (0)140 400 4381
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Email
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josef.smolen@wienkav.at
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Sponsor
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Vienna Medical University (Austria)
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Address
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Department of Internal Medicine III
Division of Rheumatology
Wahringer Gurtel 18-20
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City/town
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Vienna
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Zip/Postcode
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A-1090
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Country
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Austria
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Date applied
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23/11/2005
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Last edited
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13/03/2006
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Date ISRCTN assigned
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10/03/2006
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