Botulinum toxin: an adjunct in limb reconstruction - Can it reduce pain and joint complications in the lengthening phase?

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

ISRCTN

Registry ID

ISRCTN35609758

Enrollment

Registered

2008-02-19

Start date

2008-04-01

Completion date

Unknown

Last updated

2020-02-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Limb reconstruction surgery Surgery Limb reconstruction surgery

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

Eligibility

Sex/Gender

All

Inclusion criteria

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

Exclusion criteria

Exclusion criteria: Children with neurological aetiology

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
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	—

Measure

Time frame

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

—

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026