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ISRCTN
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ISRCTN87732015
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ClinicalTrials.gov identifier
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Public title
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A prospective, controlled randomised study investigating functional outcome, with early and late physiotherapy, on patients following a fractured proximal humerus.
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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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RBF 98X42
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Study hypothesis
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To examine the functional outcome of patients sustaining a fractured proximal humerus, following early and late physiotherapy.
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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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Injury, occupational diseases, poisoning: Musculoskeletal injury
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Participants - inclusion criteria
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120 patients sustaining fractured proximal humerus
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Participants - exclusion criteria
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Not provided at time of registration
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Anticipated start date
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01/10/1998
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Anticipated end date
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30/04/2001
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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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120
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Interventions
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1.. Physiotherapy within one week of their interviews
2. Physiotherapy at three weeks following their injury.
Both groups will receive treatment by senior physiotherapists who will be following a physiotherapy protocol for treatment and home exercises. Functional outcome measurements will be taken at three intervals.
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Primary outcome measure(s)
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Outcome measure: SF-36 and C-MSA (Constant-Murley shoulder assessment)
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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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NHS Executive Trent (UK)
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Trial website
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Publications
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1. 2003 results in http://www.ncbi.nlm.nih.gov/pubmed/12729121
2. 2007 2 -year follow-up results in http://www.ncbi.nlm.nih.gov/pubmed/17399621
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Contact name
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Mr
D
Stanley
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Address
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Orthopaedics
Northern General Hospital NHS Trust
Herries Road
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City/town
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Sheffield
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Zip/Postcode
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S5 7AU
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Country
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United Kingdom
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Tel
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+44 (0)114 271 4025
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Fax
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+44 (0)114 256 0472
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Email
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Sponsor
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NHS R&D Regional Programme Register - Department of Health (UK)
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Address
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The Department of Health
Richmond House
79 Whitehall
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City/town
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London
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Zip/Postcode
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SW1A 2NL
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Country
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United Kingdom
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Tel
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+44 (0)20 7307 2622
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Fax
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+44 (0)20 7307 2623
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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.doh.gov.uk
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Date applied
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23/01/2004
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Last edited
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09/12/2008
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Date ISRCTN assigned
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23/01/2004
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