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.

ISRCTN ISRCTN24558210
DOI https://doi.org/10.1186/ISRCTN24558210
Secondary identifying numbers N0171133935
Submission date
30/09/2004
Registration date
30/09/2004
Last edited
23/07/2009
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Nervous System Diseases
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Dr R Morton
Scientific

c/o Derby Children's Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom

Phone +44 (0)1332 340131
Email richard.morton@derbyhospitals.nhs.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeTreatment
Scientific title
Study objectivesHow 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(s)Not provided at time of registration
Health condition(s) or problem(s) studiedNervous System Diseases: Cerebral palsy
InterventionRandomised 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 typeDrug
Pharmaceutical study type(s)
PhaseNot Applicable
Drug / device / biological / vaccine name(s)Botulinum A (Dysport)
Primary outcome measure1. 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 measuresNot provided at time of registration
Overall study start date01/12/2003
Completion date01/12/2005
Reason abandoned (if study stopped)Objectives no longer viable

Eligibility

Participant type(s)Patient
Age groupChild
Lower age limit4 Years
Upper age limit12 Years
SexNot Specified
Target number of participants20
Key inclusion criteria20, 4-12 year old children. Boys and girls with cerebral palsy (hemiplegia and diplegia)
Key exclusion criteriaDoes not meet inclusion criteria
Date of first enrolment01/12/2003
Date of final enrolment01/12/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

c/o Derby Children's Hospital
Derby
DE22 3NE
United Kingdom

Sponsor information

Department of Health
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.dh.gov.uk/Home/fs/en

Funders

Funder type

Other

Nottingham Primary Care Research Partnership (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan