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Primary outcome measure:
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Number of patients classified as OMERACT/OARSI-responders in each group.
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The responder classification is a composite index reported as a single variable (responder yes/no), based on change after treatment in pain, function and patient’s global assessment.
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t2, t3
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Secondary outcomes:
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Hand pain at rest
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Numeric rating scale: 0–10, 0 is no pain
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t1, t2, t3
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Physical function
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The Functional Index for Hand OsteoArthritis is a summary score (ranging from 0 to 30) of 10 items, each scored on a four-point scale, 0 = possible without difficulty
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t1, t2, t3
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Patient’s global assessment
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Numeric rating scale: 0–10, 0 is no disease activity
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t1, t2, t3
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Activity performance
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In the Measure of Activity Performance of the Hand, as a mean of 18 standardised activities, (rating scale 1–4, 1 is no problems)
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t1, t2, t3
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Maximal grip strength
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In kg by the JAMAR dynamometer
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t1, t2,
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Painful finger joints
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Examination by a trained OT of presence of pain yes/no in CMC1, MCP, PIP and DIP-joints in both hands
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t1, t2
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Pain in activity at each hand (measured following measurement of grip strength)
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Numeric rating scale: 0–10, 0 is no pain
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t1, t2,
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Hand stiffness
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Numeric rating scale: 0–10, 0 is no stiffness
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t1, t2, t3
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Health related quality of life
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EuroQoL 5D-5 L - health-related quality of life contains five items scored at a five level scale, (“no problems” to “unable to do”) and a visual analogue scale ranging from 0 and 100. 0 corresponds to “the worst health you can imagine”.
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Satisfaction with care
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The PasOpp questionnaire contains eleven statements with a 5-point scoring scale ranging from “not at all” to “very much”, and one statement concerning waiting time with a 4-point scoring scale ranging from “not at all” to “very long”.
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t2,
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