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

This study has been completed.
Scoliosis Research Society
Information provided by (Responsible Party):
Dr Daniel Yee Tak FONG, The University of Hong Kong Identifier:
First received: October 1, 2009
Last updated: December 1, 2014
Last verified: December 2014
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).

Condition Intervention
Adolescent Idiopathic Scoliosis
Device: Brace

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Single-blind Comprehensive Cohort Study Incorporating a Randomized Controlled Design on Bracing in AIS: A Feasibility Study

Resource links provided by NLM:

Further study details as provided by The University of Hong Kong:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II. [ Time Frame: Baseline and every four months ]

Enrollment: 68
Study Start Date: October 2008
Study Completion Date: November 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brace - Randomized
Participants were randomized to be braced
Device: Brace
Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
No Intervention: Observation - Randomized
Participants were randomized to be observed only
Experimental: Brace - preference based
Participants chose to be braced
Device: Brace
Wearing a Thoraco-Lumbo-Sacral-Orthosis (TLSO) for a minimum of 20 hours per day
No Intervention: Observation - preference-based
Participants chose to be observed only

Detailed Description:
The study has been completed.

Ages Eligible for Study:   10 Years and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Diagnosis of AIS
  2. Age ≥10 years
  3. Risser sign 0-2
  4. 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:

  1. History of treatment of AIS
  2. >= 1 year postmenarchal (for girls only)
  3. Physical or mental disability to adhere to bracing
  4. Diagnosis of musculoskeletal or development illness that might be responsible for the spinal curvature
  5. Structural thoracic scoliosis with apex above T7 (Note these patients are not suitable for under-arm brace)
  6. Difficulty to read, understand, and complete the study questionnaires
  7. Any criteria, which, in the opinion of the investigator, suggests that the subject would not be compliant with the study protocol
  Contacts and Locations
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Please refer to this study by its identifier: NCT00989495

The Duchess of Kent Children's Hospital
Hong Kong, China
Sponsors and Collaborators
The University of Hong Kong
Scoliosis Research Society
Principal Investigator: Daniel YT Fong, PhD The University of Hong Kong
  More Information

Responsible Party: Dr Daniel Yee Tak FONG, Associate Professor, The University of Hong Kong Identifier: NCT00989495     History of Changes
Other Study ID Numbers: dytfong
HKCTR-819 ( Registry Identifier: Hong Kong Clinical Trials Registry )
Study First Received: October 1, 2009
Last Updated: December 1, 2014

Keywords provided by The University of Hong Kong:

Additional relevant MeSH terms:
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases processed this record on May 25, 2017