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Completed

NCT Number: NCT05424419

Add-on Nighttime Bracing in Adolescent Idiopathic Scoliosis

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.

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Key information

Conditions

Scoliosis Bone Diseases Musculoskeletal Diseases Spinal Curvatures Spinal Diseases

Age range

10 year–15 year

Sex eligibility

All sexes

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. primary correction

    Time frame: At study inclusion with initiation of brace therapy

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

Secondary outcomes

  1. Cobb angle reduction

    Time frame: 2 years after deposition of the brace

    Follow-up Cobb angle (degree) in relation to the initial Cobb angle

Sponsors and collaborators

Lead sponsor

Technische Universität Dresden

Other

Registry information

Official study title

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

Important dates

Study start
1997
Primary completion
2018
Study completion
2020
First posted
Jun 21, 2022
Registry last updated
Jun 27, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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