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ISRCTN
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ISRCTN24558210
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ClinicalTrials.gov identifier
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Public title
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Single blinded cross over trial of two, versus multiple, injections of Botulinum A (Dysport), into the gastrocnemius muscle of children with cerebral palsy, to compare efficacy and discomfort of either method.
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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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N0171133935
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Study hypothesis
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How can injection technique be improved to increase efficacy per dose of botulinum toxin, as measured by observational gait analysis.
This study will examine whether multiple injection technique treatment is more effective than single injection technique, for spastic muscle in children with cerebral palsy. We shall examine the effect of dividing the standard treatment of single injections of Botulinum to the Gastrocnemius muscle into multiple smaller injections.
We shall also compare discomfort at time of injection, by standardised child and parent reporting scales.
Null hypothesis - there is no difference in efficacy or adverse effects between single versus multiple injections.
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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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Nervous System Diseases: Cerebral palsy
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Participants - inclusion criteria
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20, 4-12 year old children. Boys and girls with cerebral palsy (hemiplegia and diplegia)
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Participants - exclusion criteria
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Does not meet inclusion criteria
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Anticipated start date
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01/12/2003
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Anticipated end date
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01/12/2005
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Status of trial
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Stopped |
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Patient information material
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Target number of participants
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20
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Interventions
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Randomised Controlled Trial.
Children are recruited to the study and consent is signed by themselves and/or their carers. They are randomised to group A or group B.
Group A:
Proceed first to single injections to the gastrocnemius 2 cm each side of the midline, one fifth of the distance from the tibial condyles to the ankle malleoli. A total dose of Botulinum A (Dysport) of 12 Units/kg, to a maximum 500 Units, is given in two divided fractions, using a concentration of Botulinum A (Dysport) 500 Units in 5 ml N saline.
Six months later they receive the same total dose of Botulinum A at the same concentration but divided into 10 fractions. Five injections are given 2 cm on either side of the midline of the muscle and evenly spaced, starting one fifth of the distance from the tibial condyles to the ankle malleoli and ending just past the major bulge of the gastrocnemius muscle.
Group B:
First receive the multiple injections, then six months later single injections using the same techniques as for Group A.
For each injection, the injected area of skin is treated with local anaesthetic gel (Amethocaine), 1 hour beforehand. Thirty minutes before injection, they are given oral midazolam 0.7 mg/kg as relaxant, and oral diclofenac 1 mg/kg as analgesic.
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Primary outcome measure(s)
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1. Efficacy of Botulinum toxin injection to that muscle, as assessed by observational gait scale, before at 4 weeks and at 12 weeks
2. The discomfort at the time of injection
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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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Nottingham Primary Care Research Partnership (UK)
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Trial website
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Publications
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Contact name
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Dr
R
Morton
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Address
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c/o Derby Children's Hospital
Uttoxeter Road
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City/town
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Derby
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Zip/Postcode
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DE22 3NE
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Country
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United Kingdom
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Tel
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+44 (0)1332 340131
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Fax
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+44 (0)1332 625935
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Email
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richard.morton@derbyhospitals.nhs.uk
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Sponsor
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Record Provided by the NHSTCT Register - 2004 Update - 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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Email
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dhmail@doh.gsi.org.uk
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Sponsor website:
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http://www.dh.gov.uk/Home/fs/en
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Date applied
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30/09/2004
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Last edited
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23/07/2009
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Date ISRCTN assigned
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30/09/2004
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