Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
Dysport ® as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
This study evaluates the combined effect of botulinum toxin A (administered as Dysport®
 (Ipsen Pharmaceuticals)) and bracing in children with adolescent idiopathic scoliosis. Two
 thirds of patients will be treated with Dysport® and bracing, while the remaining patients
 will be treated with placebo and bracing.
Adolescent idiopathic scoliosis (AIS) is lateral curvature of the spine with an unknown cause
 in children 10-16 years old. Without treatment, skeletally immature children with idiopathic
 curves of 20°-40° risk curve progression. Treatment of these patients is focused on either
 observation or bracing. Although bracing has been shown to be more effective than
 observation, success is contingent on patient adherence and has the potential for further
 optimization with adjunct therapies.

 Little research is available concerning adjunct therapies that may be used during bracing of
 AIS patients. One therapy in particular, abobotulinumtoxinA (BTX) injection, has been poorly
 studied. Injection of BTX into the paraspinal musculature of the concave aspect of the major
 curve may result in a more malleable curve and thus optimize brace treatment. If BTX
 injections are found to improve outcomes in this way, a new standard of nonoperative care
 could be established for AIS patients, potentially reducing the number of patients who
 undergo surgery.

 The aim of this study is to assess whether BTX injections (administered as Dysport® (Ipsen
 Pharmaceuticals)) in the paraspinal musculature at the site of the major scoliotic curve
 decrease curve progression in skeletally immature AIS patients who are concurrently treated
 with bracing. Dysport® will be evaluated primarily as an adjunct treatment to bracing.

 Hypotheses

 1. Dysport® injections into the concave-side paraspinal muscles will decrease the rate of
 curve progression, with a lower rate of curve progression in patients treated with both
 Dysport® injections and bracing compared with those treated with only bracing.

 2. Quantitative physical and mental health scores will improve to a greater extent in
 patients treated with Dysport® and bracing compared with patients treated with only
 bracing.
Inclusion criteria:

 -  Clinically determined idiopathic nature of scoliosis

 -  Age 10-16 years

 -  Risser stage 0,1,or 2

 -  major curve of 20°-40°

 -  curve apex caudal to T7 vertebra

 -  ability to adhere to bracing protocol

 -  Botulinum toxin naïve or previously treated greater than 6 months prior to study entry

 Exclusion criteria:

 -  Diagnosis of congenital scoliosis, neuromuscular scoliosis, or other "reason" for
 scoliosis - Previous surgery at any segment of the spine

 -  Current need for surgery at any level of the spine

 -  Treatment with any drug known to interfere with neuromuscular function

 -  Any other medical condition, laboratory or diagnostic procedure finding that might
 preclude administration of BTX

 -  Ongoing infection at the injection sites

 -  Diagnosis as either resistant or sensitive to botulinum toxin treatment of any type or
 to any components of the BTX formulation

 -  Cow milk protein allergy