Add-on Nighttime Bracing in Adolescent Idiopathic Scoliosis

Retrospektive Analyse Der Konservativen Skoliosetherapie - Doppelkorsettversorgung Mittels Tag- Und Nachtorthese Versus Ganztagesorthese

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.

Study Overview

• Status: Completed
• Conditions: Scoliosis
• Intervention / Treatment: Procedure: Brace therapy

Detailed Description

One-hundred-fifteen patients with adolescent idiopathic scoliosis (AIS) were assessed before initiation of bracing treatment and at the final follow-up 2 years after deposition of the brace. They were divided into two groups: double-brace group and single-brace group. Each patient underwent clinical and radiological examinations and Cobb angles were measured.

• Study Type: Observational
• Enrollment (Actual): 115

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 11 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Retrospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
double-brace group; AIS patients with daytime and nighttime braces	Procedure: Brace therapy; 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.
single-brace group; AIS patients with a single brace for day and night	Procedure: Brace therapy; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
primary correction	Primary correction (%) of brace therapy (Cobb angle measurement)	At study inclusion with initiation of brace therapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Cobb angle reduction	Follow-up Cobb angle (degree) in relation to the initial Cobb angle	2 years after deposition of the brace

Collaborators and Investigators

• Sponsor: Technische Universität Dresden

Study record dates

Study Major Dates

• Study Start (Actual): January 2, 1997
• Primary Completion (Actual): December 31, 2018
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: June 15, 2022
• First Submitted That Met QC Criteria: June 15, 2022
• First Posted (Actual): June 21, 2022

Study Record Updates

• Last Update Posted (Actual): June 27, 2022
• Last Update Submitted That Met QC Criteria: June 22, 2022
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Keywords: scoliosis; nighttime bracing; full-time bracing; Chêneau brace; Charleston brace
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: EK 27012018

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No