| Source of record | UK Trials |
| ISRCTN | ISRCTN35609758 |
| Date ISRCTN assigned | 19/02/2008 |
| Local reference number(s) | SCH-07-006; Sponsor ref: 7860 |
| Public title | Botulinum toxin: an adjunct in limb reconstruction - Can it reduce pain and joint complications in the lengthening phase? |
| Scientific title |
|
| Acronym | Botox |
| Disease/condition/study domain | Limb reconstruction surgery |
| 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. |
| Design/methodology | Patient/assessor-blinded, pilot, randomised controlled trial. |
| Research ethics review | An application has been submitted to the North Sheffield Research Ethics Office. Approval pending as of 18/02/2008. |
| Countries of trial | United Kingdom |
| Participants - 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 |
| Participants - exclusion criteria | Children with neurological aetiology |
| Patient information material | Not available in web format, please use the contact details below to request a patient information sheet |
| Anticipated start date | 01/04/2008 |
| Anticipated end date | 01/04/2010 |
| Status of trial | Ongoing |
| Target number of participants | 36 |
| Interventions | 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 |
| Primary outcome measure(s) | 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 measure(s) | 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 |
| Sources of funding | Sheffield Hospitals NHS Charitable Trust (UK) |
| Sponsor name | Sheffield Children's NHS Foundation Trust (UK) |
| Sponsor details | c/o Mrs Vee Mapunde
Clinical Research Facility
D Floor Stephenson Wing
Western Bank
Sheffield
United Kingdom
S10 2TH |
| Sponsor telephone | +44 (0)114 2267846 |
| Sponsor fax | +44 (0)114 2267844 |
| Sponsor email | vee.mapunde@sch.nhs.uk |
| Sponsor website | http://www.sheffieldchildrenscrf.nhs.uk |
| Contact name | Mr James A Fernandes |
| Contact details | Sheffield Children's Hospital
Western Bank
Sheffield
United Kingdom
S10 2TH |
| More information | For more up-to-date information please go to the ISRCTN link below. |
| Link to record in ISRCTN Register | ISRCTN35609758 |
| Date last extracted from ISRCTN register | 17/04/2008 |
