Scoliosis
Conditions
Interventions
Part Two: Control Group:Conventional traditional brace ( Shenu brace )
Part One: Idiopathic Scoliosis Observation Group:None
Part Two: Experimental Group:3D printing TCM syndrome differentiation brace
Sponsors
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Eligibility
Sex/Gender
All
Age
10 Years to 18 Years
Inclusion criteria
Inclusion criteria: Part One (Cross-section) : 1. Meet the diagnostic criteria for idiopathic scoliosis; 2. Age between 10 and 18 years old; 3. Those who voluntarily accept this trial and sign the informed consent form; 4. Has not received surgical or brace treatment; Part Two (Randomized Parallel Controlled Trials) : 1. Meet the diagnostic criteria for idiopathic scoliosis as mentioned above (in the first part of the study) 2. Age between 10 and 18 years old 3.Risser sign <= level 3 4. It has indications for braces 5. Those who voluntarily accept this trial and sign the informed consent form
Exclusion criteria
Exclusion criteria: Part One (Cross-section) : 1. Secondary scoliosis of the spine caused by congenital or any other clear etiology; 2. Patients with severe cardiovascular and cerebrovascular or liver and kidney, endocrine system and rheumatic diseases, as well as those with severely weak constitutions; 3. Pregnant or lactating women; 4. Those who have other internal diseases at the time of seeking medical treatment, which affect the information of the Four diagnostic methods of traditional Chinese medicine; Part Two (Randomized Parallel Controlled Trials) : 1. Secondary scoliosis of the spine caused by congenital or any other clear etiology 2. Patients with severe cardiovascular and cerebrovascular or liver and kidney, endocrine system and rheumatic diseases, as well as those with severely weak constitutions 3. Pregnant or lactating women 4. Those who have previously received brace or surgical treatment
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Cobb angle;Self-made ' AIS TCM Syndrome Scale ';Trunk imbalance; | — |
Secondary
| Measure | Time frame |
|---|---|
| Vertebral rotation;PedsQL4.0 Quality of Life Scale;Incidence of skin pressure sores;SRS-22 scale ( function / pain / self-image );Activity limited VAS score;TCM syndrome score reduction rate; | — |
Countries
China
Contacts
Public ContactXiaoming Ying
The Third Affiliated Hospital of Zhejiang Chinese Medical University
Outcome results
None listed