71 Participants Needed

Casting vs Bracing for Scoliosis

(CVBT Trial)

Recruiting at 39 trial locations
LA
DB
Overseen ByDaniel Bouton, MD
Age: < 18
Sex: Any
Trial Phase: Academic
Sponsor: University of Iowa
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

Trial Summary

Do I need to stop my current medications for the trial?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment Bracing for scoliosis?

Research suggests that bracing can help prevent the worsening of scoliosis in adolescents, especially for those with a moderate curve (Cobb angle of 25-35°). It is more effective than doing nothing and may be better than some other non-surgical treatments, although its advantage over casting is not clear.12345

Is bracing or casting safe for treating scoliosis?

Bracing for scoliosis is generally considered safe and does not negatively impact quality of life, although its effectiveness compared to other treatments like casting is still debated. Casting for early onset scoliosis is commonly used, but there are concerns about significant challenges for caregivers.16789

How does the treatment of casting and bracing for scoliosis differ from other treatments?

Casting and bracing for scoliosis are unique because they are non-surgical methods that apply external corrective forces to the spine to prevent curve progression, especially in growing adolescents. Unlike surgical options, bracing can sometimes avoid the need for surgery by stabilizing the spine during growth, while casting requires repeated general anesthesia, which has raised concerns about potential brain damage in young children.710111213

What is the purpose of this trial?

Comparison of casting and bracing for the treatment of idiopathic early onset scoliosis

Research Team

SL

Stuart L Weinstein, MD

Principal Investigator

University of Iowa

Eligibility Criteria

This trial is for children under 3 who can stand on their own and have been diagnosed with idiopathic early-onset scoliosis, showing a Cobb angle between 20° to 70°. A parent or guardian must consent to the child's participation. Children with conditions that don't meet these specific criteria are excluded.

Inclusion Criteria

Both children with scoliosis and one of their parents/guardians can participate in the study.
This is not an exclusion criterion but rather a statement that a patient is eligible to participate in the clinical trial.
This is not a complete criterion. Please provide more information.
See 7 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are treated with either serial casts or full-time braces

24 months
Regular visits every 6 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • Bracing
  • Casting
Trial Overview The study compares two methods of treating young children with scoliosis: one group will receive treatment through casting while another will use bracing. The goal is to see which method is more effective in managing this condition.
Participant Groups
2Treatment groups
Active Control
Group I: BracingActive Control1 Intervention
Subjects will be treated with full-time orthotics (braces)
Group II: CastingActive Control1 Intervention
Subjects will be treated with serial casting

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Iowa

Lead Sponsor

Trials
486
Recruited
934,000+

Orthopedic Research and Education Foundation

Collaborator

Trials
23
Recruited
6,200+

Pediatric Spine Study Group

Collaborator

Trials
1
Recruited
70+

References

Effectiveness and outcomes of brace treatment: a systematic review. [2022]
Bracing In The Treatment Of Adolescent Idiopathic Scoliosis: Evidence To Date. [2020]
Results of Bracing for Juvenile Idiopathic Scoliosis. [2020]
Is Brace Treatment Appropriate for Adolescent Idiopathic Scoliosis Patients Refusing Surgery With Cobb Angle Between 40 and 50 Degrees. [2018]
Professional opinion concerning the effectiveness of bracing relative to observation in adolescent idiopathic scoliosis. [2018]
Treatment of bracing for adolescent idiopathic scoliosis patients: a meta-analysis. [2020]
Effects of bracing in adolescents with idiopathic scoliosis. [2022]
Survey to describe variability in early onset scoliosis cast practices. [2022]
Does Transitioning to a Brace Improve HRQoL After Casting for Early Onset Scoliosis? [2023]
10.United Statespubmed.ncbi.nlm.nih.gov
The effect of orthotic interventions on balance performance in adolescent idiopathic scoliosis: A systematic literature review. [2021]
Efficacy of bracing in early infantile scoliosis: a 5-year prospective cohort shows that idiopathic respond better than secondary-2021 SOSORT award winner. [2022]
12.United Statespubmed.ncbi.nlm.nih.gov
Bracing for scoliosis. [2013]
Introduction to the "Scoliosis" Journal Brace Technology Thematic Series: increasing existing knowledge and promoting future developments. [2022]
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