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 |
| Protocol serial number | N0171133935 |
| Sponsor | Department of Health |
| Funder | Nottingham Primary Care Research Partnership (UK) |
- 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
Scientific
c/o Derby Children's Hospital
Uttoxeter Road
Derby
DE22 3NE
United Kingdom
| Phone | +44 (0)1332 340131 |
|---|---|
| richard.morton@derbyhospitals.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 / device / biological / vaccine name(s) | Botulinum A (Dysport) |
| Primary outcome measure(s) |
1. Efficacy of Botulinum toxin injection to that muscle, as assessed by observational gait scale, before at 4 weeks and at 12 weeks |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/12/2005 |
| Reason abandoned (if study stopped) | Objectives no longer viable |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 4 Years |
| Upper age limit | 12 Years |
| Sex | Not Specified |
| Key inclusion criteria | 20, 4-12 year old children. Boys and girls with cerebral palsy (hemiplegia and diplegia) |
| Key exclusion criteria | Does not meet inclusion criteria |
| Date of first enrolment | 01/12/2003 |
| Date of final enrolment | 01/12/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
c/o Derby Children's Hospital
Derby
DE22 3NE
United Kingdom
DE22 3NE
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
