Evaluation of the effects of Botulinum toxin A injections when used to improve ease of care and comfort in children with cerebral palsy whom are non-ambulant: A double blind randomized controlled trial

Thorley, Megan, Donaghey, Samantha, Edwards, Priya, Copeland, Lisa, Kentish, Megan, McLennan, Kim, Lindsley, Jayne, Gascoigne-Pees, Laura, Sakzewski, Leanne and Boyd, Roslyn N. (2012) Evaluation of the effects of Botulinum toxin A injections when used to improve ease of care and comfort in children with cerebral palsy whom are non-ambulant: A double blind randomized controlled trial. BMC Pediatrics, 12 : 120.1-120.23.


Author Thorley, Megan
Donaghey, Samantha
Edwards, Priya
Copeland, Lisa
Kentish, Megan
McLennan, Kim
Lindsley, Jayne
Gascoigne-Pees, Laura
Sakzewski, Leanne
Boyd, Roslyn N.
Title Evaluation of the effects of Botulinum toxin A injections when used to improve ease of care and comfort in children with cerebral palsy whom are non-ambulant: A double blind randomized controlled trial
Journal name BMC Pediatrics  (ERA 2012 Listed)    (ERA 2010 Rank C)   Check publisher's open access policy
Publication date 2012-08-09
Sub-type Article
DOI 10.1186/1471-2431-12-120
Volume number 12
ISSN 1471-2431
Start page 120.1
End page 120.23
Total pages 23
Place of publication London, United Kingdom
Publisher BioMed Central
Collection year 2013
Language eng
Formatted abstract Children with cerebral palsy (CP) whom are non-ambulant are at risk of reduced quality of life and poor health status. Severe spasticity leads to discomfort and pain. Carer burden for families is significant. This study aims to determine whether intramuscular injections of Botulinum Toxin A (BoNT-A) combined with a regime of standard therapy has a positive effect on care and comfort for children with CP whom are non-ambulant (GMFCS IV/V), compared with standard therapy alone (cycle I), and whether repeated injections with the same regime of adjunctive therapy results in greater benefits compared with a single injecting episode (cycle II). The regime of therapy will include serial casting, splinting and/or provision of orthoses, as indicated, combined with four sessions of goal directed occupational therapy or physiotherapy. Method/design This study is a double blind randomized controlled trial. Forty participants will be recruited. In cycle I, participants will be randomized to either a treatment group who will receive BoNT-A injections into selected upper and/or lower limb muscles, or a control group who will undergo sham injections. Both groups will receive occupational therapy and /or physiotherapy following injections. Groups will be assessed at baseline then compared at 4 and 16 weeks following injections or sham control. Parents, treating clinicians and assessors will be masked to group allocation. In cycle II, all participants will undergo intramuscular BoNT-A injections to selected upper and/or lower limb muscles, followed by therapy. The primary outcome measure will be change in parent ratings in identified areas of concern for their child's care and comfort, using the Canadian Occupational Performance Measure (COPM). Secondary measures will include the Care and Comfort Hypertonicity Scale (ease of care), the Cerebral Palsy Quality of Life Questionnaire (CP QoL-Child) (quality of life), the Caregiver Priorities and Child Health Index of Life with Disabilities Questionnaire (CPCHILD(c)) (health status) and the Paediatric Pain Profile (PPP) (pain). Adverse events will be carefully monitored by a clinician masked to group allocation.

Discussion
This paper outlines the theoretical basis, study hypotheses and outcome measures for a trial of BoNT-A injections and therapy for children with non-ambulant cerebral palsy. Trial registration Australia New Zealand Clinical Trials Registry:N12609000360213
Keyword Botulinum Toxin A
Cerebral Palsy
Pain
Comfort
Double blind randomized controlled trial
Q-Index Code C1
Q-Index Status Confirmed Code
Institutional Status UQ

 
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Created: Fri, 17 Aug 2012, 12:21:21 EST by Naomi Westwood on behalf of Paediatrics & Child Health - RBWH