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

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00989495
• Other study ID #: dytfong
• Secondary ID: HKCTR-819
• Status: Completed
• Phase: N/A
• First received: October 1, 2009
• Last updated: December 1, 2014
• Start date: October 2008
• Est. completion date: November 2011

Study information

• Verified date: December 2014
• Source: The University of Hong Kong
• Contact: n/a
• Is FDA regulated: No
• Health authority: Hong Kong: Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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).

Description:

The study has been completed.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 68
• Est. completion date: November 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 10 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

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

Locations

Country	Name	City	State
China	The Duchess of Kent Children's Hospital	Hong Kong

Sponsors (2)

Lead Sponsor	Collaborator
The University of Hong Kong	Scoliosis Research Society

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to >= 6 degree curve progression from baseline, Time to curve exceeding 45 degree, Time to surgery recommended/undertaken.		Baseline and every four months	No
Secondary	SRS-22 questionnaire, C-STAI questionnaire, C-BDI-II.		Baseline and every four months	No