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ISRCTN
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ISRCTN58537244
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DOI
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10.1186/ISRCTN58537244
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ClinicalTrials.gov identifier
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EudraCT number
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Public title
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Shoulder acute pain in primary healthcare: injection retraining effective?
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Scientific title
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Acronym
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SAPPHIRE
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Serial number at source
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G0001147
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Study hypothesis
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Our primary objective is to evaluate whether GP principals should receive extra training in giving injections for shoulder pain. Our secondary objective is to test whether cortisone injections are better than anaesthetic injections.
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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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Primary care
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Participants - inclusion criteria
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1. Patients presenting to GPs with pain in one or both shoulders lasting for less than 3 months who would otherwise have received a steroid injection in primary care
2. Clinical diagnosis of rotator cuff tendonitis based on history of pain in the deltoid area and pain during resisted active movement
3. Patients aged 18 or more
4. Patients who are able and willing and give informed consent
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Participants - exclusion criteria
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1. Patients whose pain has lasted for more than 3 months
2. Patients who would normally be referred to a rheumatologist in secondary care
3. Patients aged less than 18
4. Patients who are unable or unwilling to give informed consent
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Anticipated start date
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01/10/2002
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Anticipated end date
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31/03/2006
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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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400
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Interventions
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We shall invite a random sample of GPs to a training day about injecting shoulders. Half will attend before the trial and the other half after.
We shall randomise eligible patients between:
1. Cortisone injection by a trained GP
2. Cortisone injection by a GP who has received an extra day of training
3. Local anaesthetic injection by a trained GP
4. Local anaesthetic injection by a GP who has received an extra day of training
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Primary outcome measure(s)
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Patients will complete two generic instruments (SF-36 & EQ5D) and two specific instruments (British Shoulder Disability Questionnaire (BSDQ) and the Functional Limitations Profile) 1, 3 and 12 months after randomisation.
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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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1. 2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18820310
2. 2009 cost-effective analysis in http://www.ncbi.nlm.nih.gov/pubmed/19258378
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Contact name
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Prof
Ian
Russell
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Address
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School of Medicine
Swansea University
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City/town
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Swansea
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Zip/Postcode
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SA2 8PP
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Country
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United Kingdom
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Tel
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+44 (0)1792 602939
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Fax
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+44 (0)1792 513423
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Email
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i.t.russell@swansea.ac.uk
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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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02/05/2001
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Last edited
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25/11/2010
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Date ISRCTN assigned
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02/05/2001
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