Cummings 2009.
| Methods | RCT. Two‐arm parallel‐group design | |
| Participants | 20 participants with 32 CTEV feet who presented to a single centre Inclusion criteria: full‐term infants aged 0 to 30 days, with CTEV Dimeglio grade III Exclusion criteria: none stated PARTICIPANT CHARACTERISTICS Age: birth to 30 days Sex male (%): 60% Botulinium toxin A group Characteristics of feet: 17 feet. 3 right, 2 left, 6 bilateral Placebo group Characteristics of feet: 15 feet. 2 right, 1 left, 6 bilateral |
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| Interventions | Botulinum toxin A versus placebo Randomisation of participants (not feet) Both botulinum toxin A and placebo solutions manufactured and placed in identical vials by the manufacturer. Vials were coded by the manufacturer. A pharmacist at the centre randomly chose a vial and delivered it to the neurology clinic Gastrocnemius and tibialis posterior muscles were injected under EMG (electromyography, a technique which records activity in muscles) guidance by a paediatric neurologist prior to initiation of serial casting using the Ponseti technique After the foot deformity was corrected (heel varus ≥ neutral; forefoot adduction ≥ neutral; dorsiflexion ≥ 15°) feet were braced in reverse last shoes attached to an abduction orthosis set at 70° Feet that were not corrected with casting alone underwent a percutaneous Achilles tenotomy under local anaesthetic followed by further serial casting, until corrected Follow‐up average: 27 months (15 months to 4 years) |
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| Outcomes | Time in cast for correction Need for Achilles tenotomy Relapse rate Treatment required for correction of relapse |
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| Notes | This study did not state if children with syndromal CTEV were included or excluded | |
| Risk of bias | ||
| Bias | Authors' judgement | Support for judgement |
| Random sequence generation (selection bias) | Unclear risk | Placebo or botulinum toxin A was randomly selected by the pharmacist |
| Allocation concealment (selection bias) | Unclear risk | Vials were randomly selected by the pharmacist |
| Blinding (performance bias and detection bias) All outcomes | Low risk | Treator, assessor and participants blinded |
| Incomplete outcome data (attrition bias) All outcomes | Low risk | No missing outcome data |
| Selective reporting (reporting bias) | Unclear risk | The definition of relapse was not provided |
| Other bias | Unclear risk | Did not state if syndromal CTEV type feet were excluded |