Objective

In children with obstetrical brachial plexus palsy (OBPP), shoulder musculoskeletal deformity is the main cause of morbidity, with a loss of range of shoulder motion, pain and a reduction in social participation. Some uncontrolled studies show that early injections of botulinum toxin (BTI) in the internal shoulder rotator muscles (which cause the deformity) are one of the most promising treatments for the prevention of bony deformity. The main objective of this study will be the evaluation of the effectiveness of BTI in the internal shoulder rotator muscles at the age of 6 months in preventing an increase in posterior subluxation of the glenohumeral joint in babies with OBPP (evaluated at the ages of 5 and 12 months), compared with a placebo. Secondary objectives will be (1) to compare the effectiveness of BTI with placebo in preventing an increase in glenoid retroversion and three-dimensional deformity, and in improving active and passive joint range of motion and upper limb function and (2) to confirm good tolerance of BTI treatment.

Material/patients and methods

A randomised, controlled, double-blind study will be conducted. Sixty-two babies with unilateral OBPP at risk of posterior humeral head subluxation will be included and will have a MRI at 5 months of age. Only children with more than 5% posterior subluxation of the humeral head compared with the contralateral shoulder will be randomised in two groups: “toxin” and “placebo”. In the toxin group, the babies will receive BOTOX injections at the age of 6 months. A total of 8UI/kg will be injected in the internal shoulder rotator muscles. In the placebo group an inactive product will be injected. Evaluations will be carried out at 9 and 12 months of age. The parents will be contacted by telephone monthly between 6 and 12 months of the baby’s age in order to record any adverse events. The children will undergo repeat shoulder MRI at 12 months of age.

Results

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Discussion – conclusion

The major expected benefit is improvement in the prevention of shoulder deformity and upper limb function in children with OBPP. The presentation will focus on clinical and bibliographic rationale that led to this trial construction.