Skip to main content
OpenTrials
Completed

NCT Number: NCT00989495

Comprehensive Cohort Study of Bracing for Adolescent Idiopathic Scoliosis (AIS): A Feasibility Study

The purpose of this study is to gain initial experience and information for proper planning and conduct of a confirmatory study (a multi-centre single-blind comprehensive cohort study of bracing).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Adolescent Idiopathic Scoliosis

Age range

10 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Duchess of Kent Children's Hospital

Hong Kong, China

About this study

The study has been completed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Diagnosis of AIS
  • Age ≥10 years
  • Risser sign 0-2
  • Cobb's angle 20 deg to <25 deg with documented deterioration of at least 5 deg within the past 4 months (with a maximum of 10 days deviation), or 25 deg to <30 deg

Exclusion criteria

  • History of treatment of AIS
  • >= 1 year postmenarchal (for girls only)
  • Physical or mental disability to adhere to bracing
  • Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature
  • Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace)
  • Difficulty to read, understand, and complete the study questionnaires
  • Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol

Treatment and study plan

Brace

Device

Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day

Primary outcomes

  1. Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken.

    Time frame: Baseline and every four months

Secondary outcomes

  1. SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II.

    Time frame: Baseline and every four months

Sponsors and collaborators

Lead sponsor

The University of Hong Kong

Other

Collaborators

  • Scoliosis Research Society

Registry information

Official study title

Single-blind Comprehensive Cohort Study Incorporating a Randomized Controlled Design on Bracing in AIS: A Feasibility Study

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Oct 5, 2009
Registry last updated
Dec 3, 2014

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.

Related clinical trials

Published trials that share one or more normalized conditions with this study.