Casting vs Bracing for Scoliosis

(CVBT Trial)

Not currently recruiting at 41 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine whether casting or bracing more effectively treats idiopathic early-onset scoliosis, a spine condition that begins in young children. Researchers will divide participants into two groups: one will use braces, and the other will undergo casting. The trial seeks children under 3 years old who can stand independently and have been diagnosed with this type of scoliosis. Parents or guardians must agree to participate and complete surveys. As an unphased trial, this study provides a unique opportunity to enhance understanding of the best treatment options for young children with scoliosis.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Studies have shown that both bracing and casting are generally safe for treating scoliosis in children. Research on bracing indicates it is well-tolerated and effective, with an 89% success rate in preventing the need for surgery. Most children do not experience serious side effects when using braces.

Research on casting shows it is also a safe option, with no serious side effects reported. Serial casting effectively manages scoliosis, though some reports mention it can affect a child's quality of life during treatment. However, it does not pose significant health risks.

Overall, both treatments are non-invasive and considered safe options for managing scoliosis in young patients. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about comparing casting and bracing for scoliosis because these treatments offer different approaches to managing the condition. Casting involves using serial casts, which can be adjusted over time to gradually correct spinal curvature, potentially offering a non-invasive alternative to surgery. Bracing, on the other hand, involves wearing orthotic devices full-time to support and straighten the spine, which is less restrictive than casting and allows for more mobility. This trial aims to determine which method is more effective, providing clearer guidance for treating scoliosis without resorting to surgical options.

What evidence suggests that this trial's treatments could be effective for scoliosis?

This trial will compare the effectiveness of bracing and casting in treating idiopathic early onset scoliosis. Research has shown that bracing can control spinal curves in up to 93% of cases, particularly for curves between 30° and 39°. However, about 20% of patients may still require surgery despite bracing. Participants in the bracing arm of this trial will receive full-time orthotics.

In contrast, those in the casting arm will undergo serial casting. Research suggests this method can reduce the spinal curve by an average of 22.2° and may delay or even prevent the need for surgery. Casting has "cured" between 35-69% of patients and helps maintain spinal growth. Both treatments aim to manage the curve's progression and reduce the likelihood of surgery. ^{3 4 6 7 8}

Who Is on the Research Team?

Stuart L Weinstein, MD

Principal Investigator

University of Iowa

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12021973/

Bracing effectiveness in idiopathic early onset scoliosis ... This systematic review and meta-analysis evaluates the effectiveness of spinal bracing in idiopathic EOS, followed to skeletal maturity.

2. sciencedirect.com sciencedirect.com/science/article/pii/S2773157X25000682

Outcomes of spinal bracing and its associated factors ... The literature shows positive results as well as negative results on the effectiveness of bracing in scoliosis.

3. eurjmedres.biomedcentral.com eurjmedres.biomedcentral.com/articles/10.1186/s40001-024-02112-y

Results of bracing adolescent idiopathic scoliosis in the ... Regarding the outcome of all patients treated with brace in this study, surgery was ultimately recommended in 20% of patients, curve progression ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12511000/

Early Night-Time Bracing for Mild Adolescent Idiopathic ... Notably, the Providence brace has demonstrated success rates of 88% for curves between 20° and 29°, 93% for curves between 30° and 39°, and 77% ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2768276524002554

Scoliosis Bracing: Details Make the Difference Curves that are smaller than 25 degrees at brace initiation in skeletally immature patients have been successfully treated and include 25% of patients who ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8603182/

Brace treatment for patients with scoliosis: State of the art (2019), a success rate of 89% was reported. The authors reported to have utilised the SRS inclusion criteria for studies on bracing (Richards et al. 2005). In ...

7. nejm.org nejm.org/doi/full/10.1056/NEJMoa1307337

Effects of Bracing in Adolescents with Idiopathic Scoliosis Bracing significantly decreased the progression of high-risk curves to the threshold for surgery in patients with adolescent idiopathic scoliosis.

8. answers.childrenshospital.org answers.childrenshospital.org/scoliosis-brace-research/

Bracing could change the game in scoliosis treatment Many patients who adhered to bracing, as this patient did, showed significant curve correction. These results, says Hresko, are reason to change ...