Trial Information

Summary: Pediatric Scoliosis Research Study

What is the purpose of this study?

The purpose of this study is to evaluate whether the use of bracing lowers the risk of curve progression in patients with adolescent idiopathic scoliosis (AIS). The study will compare changes in the spinal curve over time in participants who wear a brace and those who do not.

What is involved?

The study lasts for approximately 3-5 years, depending on your child’s age and skeletal maturity (as measured by your child’s physician) and includes approximately 5-7 visits.

The following is a list of procedures that will take place during the study:

• Randomized to receive either bracing or watchful waiting
• Standard examinations and X-Rays for clinical care of AIS
• Health and well-being surveys

What are the benefits?

The greatest benefit is that your child will be contributing to research that may help adolescents with AIS in the future. Clinical studies are essential in finding new and improved treatments and diagnostic tools. Your child may or may not receive direct benefit from the study; however, your child will continue to receive the standard of care for AIS and will be carefully monitored throughout the study by their doctor.

Will I get all the facts about the study?

Parents interested in having their child participate will be provided with a consent form that thoroughly explains all of the details of the study and describes all of the procedures, the risks, the benefits, the pay, who to contact with questions or concerns and more. A member of the study staff will review the consent form with you and will be sure that all of your questions are answered. Study procedures will not begin until a parent/guardian has signed this form, and if of age, the child has given at minimum his/her verbal agreement.

What are the risks?

There are no additional risks to participants enrolled in this study compared with adolescents receiving routine care, such as bracing or watchful waiting, for AIS (adolescent idiopathic scoliosis). Participants with bracing could experience some discomfort from the brace and/or skin abrasion and irritation.

What is the pay?

Participants will receive $25 at each study visit.

Who will be included in this study?

Adolescents 10-15 years old who have been diagnosed with AIS (adolescent idiopathic scoliosis) with curves measuring between 25 and 40 degrees and who have not previously undergone bracing or surgery are eligible for participation.

If you would like to learn more about participating in this study, please send an e-mail message using the form below.