Add-on Nighttime Bracing in Adolescent Idiopathic Scoliosis

NCT ID: NCT05424419

Last Updated: 2022-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

1997-01-02

Study Completion Date

2020-12-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Scoliosis

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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double-brace group

AIS patients with daytime and nighttime braces

Brace therapy

Intervention Type 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.

single-brace group

AIS patients with a single brace for day and night

Brace therapy

Intervention Type 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.

Interventions

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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.

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

10 Years

Maximum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Technische Universität Dresden

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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EK 27012018

Identifier Type: -

Identifier Source: org_study_id

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