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Add-on Nighttime Bracing in Adolescent Idiopathic Scoliosis

T

Technische Universität Dresden

Status

Completed

Conditions

Scoliosis

Treatments

Procedure: Brace therapy

Study type

Observational

Funder types

Other

Identifiers

NCT05424419
EK 27012018

Details and patient eligibility

About

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.

Full 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.

Enrollment

115 patients

Sex

All

Ages

10 to 15 years old

Volunteers

No Healthy Volunteers

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

Trial design

115 participants in 2 patient groups

double-brace group
Description:
AIS patients with daytime and nighttime braces
Treatment:
Procedure: Brace therapy
single-brace group
Description:
AIS patients with a single brace for day and night
Treatment:
Procedure: Brace therapy

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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