Casting vs Bracing for Scoliosis

(CVBT Trial)

Recruiting at 39 trial locations

Overseen By Daniel Bouton, MD

Age: < 18

Sex: Any

Trial Phase: Academic

Sponsor: University of Iowa

Disqualifiers: Previous treatment, Developmental delay, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 6

Duration: 24 months

71 Participants Needed

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. ^{1 2 3 4 5}

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. ^{1 6 7 8 9}

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. ^{7 10 11 12 13}

What is the purpose of this trial?

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

Research Team

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.

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

Group I: Bracing Active Control 1 Intervention

Subjects will be treated with full-time orthotics (braces)

Group II: Casting Active Control 1 Intervention

Subjects will be treated with serial casting

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

1. England pubmed.ncbi.nlm.nih.gov

Effectiveness and outcomes of brace treatment: a systematic review. [2022]

2. New Zealand pubmed.ncbi.nlm.nih.gov

Bracing In The Treatment Of Adolescent Idiopathic Scoliosis: Evidence To Date. [2020]

3. England pubmed.ncbi.nlm.nih.gov

Results of Bracing for Juvenile Idiopathic Scoliosis. [2020]

4. United States pubmed.ncbi.nlm.nih.gov

Is Brace Treatment Appropriate for Adolescent Idiopathic Scoliosis Patients Refusing Surgery With Cobb Angle Between 40 and 50 Degrees. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Professional opinion concerning the effectiveness of bracing relative to observation in adolescent idiopathic scoliosis. [2018]

6. Germany pubmed.ncbi.nlm.nih.gov

Treatment of bracing for adolescent idiopathic scoliosis patients: a meta-analysis. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

Effects of bracing in adolescents with idiopathic scoliosis. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Survey to describe variability in early onset scoliosis cast practices. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Does Transitioning to a Brace Improve HRQoL After Casting for Early Onset Scoliosis? [2023]

10. United States pubmed.ncbi.nlm.nih.gov

The effect of orthotic interventions on balance performance in adolescent idiopathic scoliosis: A systematic literature review. [2021]

11. Germany pubmed.ncbi.nlm.nih.gov

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 States pubmed.ncbi.nlm.nih.gov

Bracing for scoliosis. [2013]

13. England pubmed.ncbi.nlm.nih.gov

Introduction to the "Scoliosis" Journal Brace Technology Thematic Series: increasing existing knowledge and promoting future developments. [2022]