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NCT03676712 Clinical Trial

The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial

Scoliosis Idiopathic Clinical Trial

Official title:
The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT03676712
Other study ID # B-1805/471-002
Secondary ID
Status Terminated
Phase N/A
First received
Last updated
Start date September 3, 2018
Est. completion date September 3, 2019

Study information
Verified date July 2020
Source Seoul National University Hospital
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The Effect of Flexible Thoracolumbar Brace on Idiopathic Scoliosis, Prospective, Randomized, Open-label Trial

Recruitment information / eligibility
Status Terminated
Enrollment 17
Est. completion date September 3, 2019
Est. primary completion date September 3, 2019
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years to 18 Years
Eligibility Inclusion Criteria:

- who have idiopathic scoliosis, showing at Cobb's angle over 20 degrees,less than 45 on X-ray

Exclusion Criteria:

- Patients who underwent spinal surgery

- Patients with spinal scoliosis due to cerebral palsy, muscle paralysis, polio, congenital spinal abnormalities

- Patients observed with Cobb's angle less than 20 degrees, over 45 degrees

- Patients complaining of acute low back pain

- Patients with cognitive impairment, severe mental illness, and inability to communicate

Study Design

Related Conditions & MeSH terms

Intervention

Device:
• scoliosis brace
Wear at least 18 hours a day

Locations
Country Name City State
Korea, Republic of Seoul National University Bundang Hospital Seongnam Gyeonggi-do

Sponsors (1)
Lead Sponsor Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome
Type Measure Description Time frame Safety issue
Primary cobb angle measure lateral curve of vertebra on spine x-ray AP view through study completion, an average of 6 months
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