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

The University of Hong Kong (HKU)

Status: Completed

Conditions: Adolescent Idiopathic Scoliosis

Treatments: Device: Brace

Study type: Interventional

Funder types: Other

Identifiers

NCT00989495

HKCTR-819 (Registry Identifier)

dytfong

Details and patient eligibility

About

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).

Full description

The study has been completed.

Enrollment: 68 patients

Sex: All

Ages: 10+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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68 participants in 4 patient groups

Brace - Randomized

Experimental group

Description:

Participants were randomized to be braced

Treatment:

Device: Brace

Observation - Randomized

No Intervention group

Description:

Participants were randomized to be observed only

Brace - preference based

Experimental group

Description:

Participants chose to be braced

Treatment:

Device: Brace

Observation - preference-based

No Intervention group

Description:

Participants chose to be observed only