Contact information
Type
Scientific
Primary contact
Dr R Morton
ORCID ID
Contact details
c/o Derby Children's Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
+44 (0)1332 340131
richard.morton@derbyhospitals.nhs.uk
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0171133935
Study information
Scientific title
Acronym
Study hypothesis
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.
Ethics approval
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Condition
Nervous System Diseases: Cerebral palsy
Intervention
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.
Intervention type
Drug
Phase
Not Applicable
Drug names
Botulinum A (Dysport)
Primary outcome measures
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
Secondary outcome measures
Not provided at time of registration
Overall trial start date
01/12/2003
Overall trial end date
01/12/2005
Reason abandoned
Objectives no longer viable
Eligibility
Participant inclusion criteria
20, 4-12 year old children. Boys and girls with cerebral palsy (hemiplegia and diplegia)
Participant type
Patient
Age group
Child
Gender
Not Specified
Target number of participants
20
Participant exclusion criteria
Does not meet inclusion criteria
Recruitment start date
01/12/2003
Recruitment end date
01/12/2005
Locations
Countries of recruitment
United Kingdom
Trial participating centre
c/o Derby Children's Hospital
Derby
DE22 3NE
United Kingdom
Sponsor information
Organisation
Department of Health
Sponsor details
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
Sponsor type
Government
Website
Funders
Funder type
Other
Funder name
Nottingham Primary Care Research Partnership (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary