Optimized Nighttime Brace for Scoliosis

This trial tests a new type of brace for treating adolescent idiopathic scoliosis, a condition where the spine curves sideways during growth spurts. Researchers aim to determine if a custom-designed brace, optimized for better fit and correction, is more effective than a standard brace. Teens with a diagnosed curve between 20 and 40 degrees who are still growing might be suitable participants. The study seeks to improve brace design to help those with scoliosis live more comfortably. As an unphased trial, it offers a unique opportunity to contribute to advancements in scoliosis treatment and potentially benefit from a more comfortable brace design.

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Research shows that nighttime braces, such as the Optimized Providence brace, are generally safe for treating scoliosis. Studies have found that these braces are usually comfortable to wear at night, and most kids and teens adapt to them without major issues.

The Optimized Providence brace is specially designed for a custom fit. Although recent studies don't provide detailed safety data, the custom fit often reduces discomfort and skin irritation, common concerns with braces.

Researchers are excited about the Optimized Providence brace for scoliosis because it uses cutting-edge optimization and finite element analysis to enhance its design. Unlike the conventional Providence brace, which relies on traditional design methods by an orthotist, the optimized version aims to offer a more customized and potentially more effective fit for patients. This advanced approach could lead to improved comfort and better spinal correction during nighttime use, making it a promising development for scoliosis management.

Research shows that the Providence nighttime brace is as effective as a full-time brace for treating moderate curves in adolescent idiopathic scoliosis (AIS). Studies have found that this brace works well for patients with certain spine curves, especially those below the T6 vertebra. In this trial, participants will join one of two groups: one will receive the Conventional Providence brace, while the other will receive the Optimized Providence brace. The new brace being tested uses advanced design techniques to improve results by tailoring the fit and pressure points for each patient. This aims to provide better and more comfortable correction during nighttime use. Existing evidence supports the effectiveness of the Providence brace, and the new version is expected to offer even greater benefits.¹³⁶⁷⁸