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ISRCTN
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ISRCTN87954265
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DOI
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10.1186/ISRCTN87954265
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Managing knee pain with simple analgesia: the efficacy, cost and adherence implications
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Scientific title
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Acronym
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N/A
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Serial number at source
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G9900285
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Study hypothesis
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1. Treatment trial: to test the hypothesis that continuous use of simple analgesia in osteoarthritis (OA) knee is more effective in reducing pain in the affected joint than analgesia used on an 'as required' basis.
2. Adherence trial: to test the hypothesis that a simple intervention delivered by practice nurses can increase adherence to continuous analgesia.
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Lay summary
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Ethics approval
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Not provided at time of registration
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Study design
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Randomised controlled trial
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Countries of recruitment
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United Kingdom
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Disease/condition/study domain
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Osteoarthritis of the knee
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Participants - inclusion criteria
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1. Male and female patients over 55 years
2. Clinical diagnosis osteoarthritis of the knee
3. Current joint pain score greater than 30 on a 10 mm visual analogue scale
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Participants - exclusion criteria
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1. Serious concomitant illness
2. Other pain-related conditions
3. Abnormal liver function tests
4. History of analgesic abuse or overdose
5. Severe OA awaiting joint replacement
6. Psychological disorders requiring treatment
7. Patients unable to follow instructions/complete questionnaires.
8. Use of over the counter medication containing paracetamol for duration of the study
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Anticipated start date
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01/09/1999
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Anticipated end date
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01/03/2002
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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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244 - Discontinued after March 2002
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Interventions
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Treatment trial:
1. Continuous use paracetamol (4 g daily)
2. 'As required' paracetamol (up to 4 g daily as needed)
Adherence trial (all patients in treatment group 1):
1. Individualised educational intervention to promote adherence delivered by practice nurse
2. No intervention
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Primary outcome measure(s)
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Treatment trial: pain in the affected joint measured by 100 mm visual analogue scale
Adherence trial: Proportion of patients who adhere to the regimen for continuous paracetamol
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Secondary outcome measure(s)
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Not provided at time of registration
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Sources of funding
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Medical Research Council (MRC) (UK)
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Trial website
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Publications
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Trial not published due to insufficient number of participants
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Contact name
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Dr
Alison
Carr
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Address
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Academic Rheumatology
University of Nottingham
Clinical Sciences Building
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City/town
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Nottingham
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Zip/Postcode
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NG5 1PB
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Country
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United Kingdom
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Email
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Sponsor
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Medical Research Council (MRC) (UK)
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Address
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20 Park Crescent
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City/town
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London
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Zip/Postcode
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W1B 1AL
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Country
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United Kingdom
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Tel
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+44 (0)20 7636 5422
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Fax
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+44 (0)20 7436 6179
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Email
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clinical.trial@headoffice.mrc.ac.uk
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Sponsor website:
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http://www.mrc.ac.uk
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Date applied
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23/10/2000
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Last edited
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30/07/2009
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Date ISRCTN assigned
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23/10/2000
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