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ISRCTN
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ISRCTN34475330
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ClinicalTrials.gov identifier
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Public title
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Ultrasound therapy for lateral epicondylitis. A double blind randomised placebo controlled trial
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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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N0544103837
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Study hypothesis
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Ultrasound therapy for lateral epicondylitis
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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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Musculoskeletal Diseases: Lateral epicondylitis (tennis elbow)
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Participants - inclusion criteria
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200 18-75 year olds (PROJ)
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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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11/09/2000
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Anticipated end date
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11/09/2003
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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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200
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Interventions
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To evaluate the effects of ultrasound in the treatment of lateral epicondylitis. Adult subjects with lateral epicondylitis will be randomised to receive either ultrasound (US) or sham (S) therapy. In the US group pulsed ultrasound will be delivered at a standardised dosage, initially five times weekly for 3 weeks, then three times weekly for 3 weeks. A single machine will be used and calibrated twice daily. The patient, assessor and treating clinician will be blinded. Outcome measures will be recorded at 6 weeks and at 9 months from baseline. These will include a forearm evaluation score and pain (primary measures), grip strength, flexibility, inflammation (thermographic score), quality of life and general health status, a summary item of status of the injury and a follow up transition item.
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Primary outcome measure(s)
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Not provided at time of registration
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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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Cambridge Consortium - Addenbrookes
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Trial website
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Publications
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Contact name
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Dr
Cathy
Speed
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Address
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Box No 204
Department of Rheumatology
Addenbrooke's NHS Trust
Hills Road
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City/town
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Cambridge
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Zip/Postcode
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CB2 2QQ
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Country
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United Kingdom
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Tel
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+44 01223 586518
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Fax
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+44
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Email
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cas50@medschl.cam.ac.uk
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Sponsor
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Record provided by the NHS Trusts Clinical Trials 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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12/09/2003
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Last edited
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21/11/2005
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Date ISRCTN assigned
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12/09/2003
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