Add-on Nighttime Bracing in Adolescent Idiopathic Scoliosis

NCT05424419 | Completed

• 1 other identifier: EK 27012018
• Study Type: observational
• Target: 115
• Locations: 0 countries
• Sites: N/A

Brief Summary

Bracing is an accepted standard therapy for idiopathic scoliosis at Cobb angle ranges between 25° and 45°. However, it is unclear, if a specifically tailored regimen of daytime and nighttime braces (=double brace) yields superior results compared to the standard treatment (single brace for day and night). These two treatment regimens were investigated in the study.

Conditions

Scoliosis

Keywords

scoliosis; nighttime bracing; full-time bracing; Chêneau brace; Charleston brace

Outcome Measures

Primary Outcomes (1)

• primary correction

  Primary correction (%) of brace therapy (Cobb angle measurement)

  At study inclusion with initiation of brace therapy

Secondary Outcomes (1)

• Cobb angle reduction

  2 years after deposition of the brace

Study Arms (2)

double-brace group

AIS patients with daytime and nighttime braces

Procedure: Brace therapy

single-brace group

AIS patients with a single brace for day and night

Procedure: Brace therapy

Interventions

Brace therapy PROCEDURE

A Chêneau-type brace was made to be worn as a full-time brace or during daytime only (double-brace group), whereas the nighttime brace was produced according to the Charleston approach.

double-brace group; single-brace group

Eligibility Criteria

• Age: 10 Years - 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Patients with AIS were managed as recommended by SOSORT Consensus statement. Inclusion criteria were according to the Scoliosis Research Society criteria. Initial diagnostics included a clinical examination, standardized X-ray of the entire spine in standing position. Patients for whom cost coverage of double-brace therapy was denied by the health insurance company received a single full-day and nighttime Chêneau type brace treatment. All other patients received a Chêneau brace for daytime and a Charleston type nighttime bending brace. Patients who were prescribed the brace were instructed to wear it for 23 hours/day. Patients were seen at 6-month intervals, at which times we collected radiographic, clinical, orthotic, and self-reported data.

You may qualify if:

• AIS
• age between 10 and 15 years (y)
• Risser's sign of 0-2
• Cobb curvature angle of 25-40°
• no previous treatment
• compliance (at least 23 h wearing time)

You may not qualify if:

• non-idiopathic scoliosis
• Cobb curvature angle \>40°
• \<10 years and \>15 years for initial treatment

Sponsors & Collaborators

• Technische Universität Dresden: lead

MeSH Terms

Conditions

Scoliosis

Condition Hierarchy (Ancestors)

Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2022
• First Posted: June 21, 2022
• Study Start: January 2, 1997
• Primary Completion: December 31, 2018
• Study Completion: December 31, 2020
• Last Updated: June 27, 2022

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will not share