Using Dysport® with bracing to treat adolescent idiopathic scoliosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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• MRI-guided dynamic support for correcting adolescent scoliosis

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• Detecting scoliosis progression without X-rays using Momentum Spine app

  This study tests whether the Momentum Spine app can reliably detect scoliosis progression in 8-18 year olds without radiographs and guide follow-up care.

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• Examining how spinal manipulation affects motor control in adolescents with scoliosis

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  Recruiting The First Affiliated Hospital of Zhejiang Chinese Medical University · Hangzhou · NCT06758115

• Using a 3D camera to assess scoliosis in adolescents

  This study is testing a new way to check the spine of teenagers with scoliosis using a special 3D camera to see if it’s better and safer than traditional X-rays.

  Recruiting The First Affiliated Hospital of Zhejiang Chinese Medical University · Hangzhou, Zhejiang · NCT06717568

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.