Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
SCH-07-006; Sponsor ref: 7860
Study information
Scientific title
Acronym
Botox
Study hypothesis
The surgery to correct leg and foot deformities in children is a lengthy, and sometimes, difficult procedure. Metal frames are attached to the leg and/or foot and over a period of time the frame is manipulated to obtain the corrected position. During this period the muscles and skin become very tight which causes pain and may pull the joint out of position. When this happens it is sometimes necessary to stop the treatment before the best position is obtained. This means that not only is the child left with an inadequate result but that further surgery is required in the future. If the tension could be removed whilst the treatment is underway this would reduce the pain, the possibility of joint damage and potentially allow a more satisfactory to be obtained without the need for further surgery.
Botulinum toxin or Botox®, as it is commonly called, has the potential to temporarily reduce the tension in the muscles without causing permanent damage.
Ethics approval
An application has been submitted to the North Sheffield Research Ethics Office. Approval pending as of 18/02/2008.
Study design
Patient/assessor-blinded, pilot, randomised controlled trial.
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
Limb reconstruction surgery
Intervention
Trail status amended to 'stopped' as of 05/04/2013 due to notification that the study was withdrawn.
Patients and the researcher collecting data will be blinded to the allocation of treatment.
Intervention group: Botulinum toxin intramuscular injections, 4 units per kg body weight
Control group: Saline injections
Intervention type
Drug
Phase
Not Specified
Drug names
Botulinum toxin (Botox®)
Primary outcome measure
Pain levels using a visual analogue scale validated at the Sheffield Children's Hospital. Following discharge from hospital, patients will be asked to continue recording pain level three times a day for 18 month or until discharged i.e. end of episode, which ever is first.
Secondary outcome measures
1. Range of movement in affected joints measured by a goniometre, recorded at each clinic visit until one month from the end of lengthening
2. Walking measured using a pedometer, recorded at each clinic visit until one month from the end of lengthening
3. Scores of the Child Health Questionnaire and the Pediatric Outcome Data Collection Instrument, administered pre-operatively, one month post-lengthening completion and one year from surgery
Overall trial start date
01/04/2008
Overall trial end date
01/04/2010
Reason abandoned (if study stopped)
Lack of funding/sponsorship
Eligibility
Participant inclusion criteria
1. Any child having reconstruction surgery which involves the distraction of bone and or soft tissue for femoral or tibial deformity and congenital talipes equinovarus.
2. Children between the ages of 6 and 18 years attending the Sheffield Children's NHS Trust
Participant type
Patient
Age group
Child
Gender
Both
Target number of participants
36
Participant exclusion criteria
Children with neurological aetiology
Recruitment start date
01/04/2008
Recruitment end date
01/04/2010
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Sheffield Children's Hospital
Sheffield
S10 2TH
United Kingdom
Sponsor information
Organisation
Sheffield Children's NHS Foundation Trust (UK)
Sponsor details
c/o Mrs Vee Mapunde
Clinical Research Facility
D Floor Stephenson Wing
Western Bank
Sheffield
S10 2TH
United Kingdom
+44 (0)114 2267846
vee.mapunde@sch.nhs.uk
Sponsor type
Government
Website
Funders
Funder type
Charity
Funder name
Sheffield Hospitals NHS Charitable Trust (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
Basic results (scientific)
Publication list