Using Dysport® with bracing to treat adolescent idiopathic scoliosis
Dysport ® (abobotulinumtoxinA) as an Adjunctive Treatment to Bracing in the Management of Adolescent Idiopathic Scoliosis
This study is testing if using Dysport® injections along with a brace can help kids aged 10-16 with scoliosis have better results and prevent their spine from getting worse.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 10 Years to 16 Years |
| Sex | All |
| Sponsor | Johns Hopkins University Academic / other |
| Locations | 1 site (Baltimore, Maryland) |
| Trial ID | NCT03935295 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of botulinum toxin A (Dysport®) as an adjunctive treatment alongside bracing for children with adolescent idiopathic scoliosis (AIS). It involves administering Dysport® injections into the paraspinal muscles of the concave side of the major curve in skeletally immature patients aged 10-16 years. The study compares outcomes between patients receiving Dysport® and those receiving a placebo, both while adhering to a bracing protocol. The goal is to determine if Dysport® can reduce curve progression and improve the effectiveness of bracing in managing AIS.
Who should consider this trial
Good fit: Ideal candidates are skeletally immature children aged 10-16 years with idiopathic scoliosis, a major curve of 20°-40°, and who can adhere to a bracing protocol.
Not a fit: Patients with congenital or neuromuscular scoliosis, previous spinal surgery, or those currently requiring surgery will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could establish a new standard of nonoperative care for adolescent idiopathic scoliosis, potentially reducing the need for surgical interventions.
How similar studies have performed: While there is limited research on the use of botulinum toxin as an adjunct therapy in scoliosis treatment, this approach is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Baltimore, Maryland
- Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Paul Sponseller, MD, MBA — Johns Hopkins Hospital Department of Orthopaedic Surgery
- Study coordinator: Gabrielle Reichard, MA
- Email: greicha1@jhmi.edu
- Phone: 4105023626
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.