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Main
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Note: This record shows only the 20 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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17 October 2012 |
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Main ID: |
NCT01370057 |
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Date of registration:
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20/05/2011 |
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Primary sponsor: |
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Public title:
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The Use of Thoraco-lumbo-sacral Orthoses (TLSOs) in the Treatment of Adolescent Idiopathic Scoliosis (AIS)
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Scientific title:
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The Use of TLSOs in the Treatment of Adolescent Idiopathic Scoliosis: A Prospective, Randomized Controlled Study |
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Date of first enrolment:
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May 2011 |
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Target sample size:
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40 |
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Recruitment status: |
Recruiting |
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URL:
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http://clinicaltrials.gov/show/NCT01370057 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
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Countries of recruitment
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China
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Contacts
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Name:
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Tsz Ping Lam, MB.,BS |
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Address:
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Telephone:
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852-26323309 |
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Email:
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tplam@ort.cuhk.edu.hk |
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Affiliation:
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Name:
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Tsz Ping Lam, MB.,BS |
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Address:
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Telephone:
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852-26323309 |
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Email:
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tplam@ort.cuhk.edu.hk |
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Affiliation:
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Key inclusion & exclusion criteria
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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
Age minimum:
10 Years
Age maximum:
15 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Scoliosis
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Intervention(s)
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Device: Thoraco-lumbo-sacral Orthosis
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Other: Watchful waiting
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Primary Outcome(s)
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Curve progression
[Time Frame: Till cessation of growth or progression of curve severity to 50 degrees or more, patient will be followed once every 6 months, an average follow up of 3 years is expected]
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Secondary ID(s)
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BRAIST HK PROTOCOL VER1
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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