Botulinum toxin: an adjunct in limb reconstruction - Can it reduce pain and joint complications in the lengthening phase?
| ISRCTN | ISRCTN35609758 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35609758 |
| ClinicalTrials.gov number | NCT00624299 |
| Secondary identifying numbers | SCH-07-006; Sponsor ref: 7860 |
- Submission date
- 18/02/2008
- Registration date
- 19/02/2008
- Last edited
- 30/01/2020
- Recruitment status
- Stopped
- Overall study status
- Stopped
- Condition category
- Surgery
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
Mr James A Fernandes
Scientific
Scientific
Sheffield Children's Hospital
Western Bank
Sheffield
S10 2TH
United Kingdom
Study information
| Study design | Patient/assessor-blinded, pilot, randomised controlled trial. |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet |
| Scientific title | Botulinum toxin: an adjunct in limb reconstruction - Can it reduce pain and joint complications in the lengthening phase? |
| Study acronym | Botox |
| Study objectives | 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(s) | An application has been submitted to the North Sheffield Research Ethics Office. Approval pending as of 18/02/2008. |
| Health condition(s) or problem(s) studied | Limb reconstruction surgery |
| Intervention | 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 |
| Pharmaceutical study type(s) | |
| Phase | Not Specified |
| Drug / device / biological / vaccine name(s) | 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 study start date | 01/04/2008 |
| Completion date | 01/04/2010 |
| Reason abandoned (if study stopped) | Lack of funding/sponsorship |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Both |
| Target number of participants | 36 |
| Key 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 |
| Key exclusion criteria | Children with neurological aetiology |
| Date of first enrolment | 01/04/2008 |
| Date of final enrolment | 01/04/2010 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Sheffield Children's Hospital
Sheffield
S10 2TH
United Kingdom
S10 2TH
United Kingdom
Sponsor information
Sheffield Children's NHS Foundation Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
c/o Mrs Vee Mapunde
Clinical Research Facility
D Floor Stephenson Wing
Western Bank
Sheffield
S10 2TH
England
United Kingdom
| Phone | +44 (0)114 2267846 |
|---|---|
| vee.mapunde@sch.nhs.uk | |
| Website | http://www.sheffieldchildrenscrf.nhs.uk |
"ROR" |
https://ror.org/02md8hv62 |
Funders
Funder type
Charity
Sheffield Hospitals NHS Charitable Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
30/01/2020: Following scientific peer review of the protocol the feedback received raised ethical issues on the basis that a larger, similar study was being conducted in Canada and on this basis it was recommended that the study does not receive additional funding. Following this advice the decision was taken not to proceed with the trial. No participants have been recruited therefore there are no adverse implications for this decision.
10/09/2019: ClinicalTrials.gov number added.
05/04/2013: Trial status amended to 'stopped' due to notification that the study was withdrawn.
