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

This study has been completed.
Sponsor:
Collaborator:
Scoliosis Research Society
Information provided by (Responsible Party):
Dr Daniel Yee Tak FONG, The University of Hong Kong
ClinicalTrials.gov Identifier:
NCT00989495
First received: October 1, 2009
Last updated: December 1, 2014
Last verified: December 2014
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II. [ Time Frame: Baseline and every four months ] [ Designated as safety issue: No ]

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.

  Eligibility

Ages Eligible for Study:   10 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00989495

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

No publications provided

Responsible Party: Dr Daniel Yee Tak FONG, Associate Professor, The University of Hong Kong
ClinicalTrials.gov Identifier: NCT00989495     History of Changes
Other Study ID Numbers: dytfong, HKCTR-819
Study First Received: October 1, 2009
Last Updated: December 1, 2014
Health Authority: Hong Kong: Ethics Committee

Keywords provided by The University of Hong Kong:
AIS

Additional relevant MeSH terms:
Scoliosis
Bone Diseases
Musculoskeletal Diseases
Spinal Curvatures
Spinal Diseases

ClinicalTrials.gov processed this record on May 21, 2015