The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the Treatment of Adolescent Idiopathic Scoliosis (AIS)

The Chinese University of Hong Kong

Status: Terminated

Conditions: Scoliosis

Treatments: Device: Thoraco-lumbo-sacral Orthosis

Study type: Interventional

Funder types: Other

Identifiers

NCT01370057

BRAIST HK PROTOCOL VER1

Details and patient eligibility

About

The purpose of this study is to compare the risk of curve progression in Adolescent Idiopathic Scoliosis for subjects treated with bracing as compared to those without bracing.

Enrollment: 2 patients

Sex: All

Ages: 10 to 15 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Confirmed Diagnosis of AIS
• Age ≥10, ≤15 years old
• Risser 0, 1 or 2
• Primary Cobb angle between 20 and 40 degrees (inclusive)
• Apex (of at least one of the primary curves) caudal to T7
• Pre-menarchal OR post-menarchal by ≤1 year
• Physical and mental ability to adhere to bracing protocol

Exclusion criteria

• Diagnosis of other musculoskeletal or developmental illnesses possibly responsible for the curvature
• A history of previous surgical or orthotic treatment
• Inability to read and understand Chinese

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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2 participants in 2 patient groups

Treatment Group

Experimental group

Description:

Treatment with bracing

Treatment:

Device: Thoraco-lumbo-sacral Orthosis

Control Group

No Intervention group

Description:

Watchful waiting without bracing