Orthopaedic Manipulation in Treatment of Adolescent Idiopathic Scoliosis

Study Overview
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Brief Summary
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To examine the clinical efficacy of the Orthopaedic Manipulation Techniques of the Lin School of Lingnan Region in the treatment of Adolescent Idiopathic Scoliosis

Detailed Description
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After being informed about the study and potential risk, all patients giving written informed consent will undergo a 0-week screening period to determine eligibility for study entry. At week 0, patients who meet the eligibility requirements will be randomized in a single-blind manner(participant) in a 1:1 ratio to Manipulation Techniques Group or Control Group.

Official Title
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The Orthopaedic Manipulation Techniques of the Lin School of Lingnan Region in the Treatment of Adolescent Idiopathic Scoliosis - A Randomized Controlled Study

Conditions
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Adolescent Idiopathic Scoliosis

Intervention / Treatment
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* Other: Manipulation Techniques
* Other: Physiotherapy Scoliosis-Specific Exercise


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adolescents aged between 10 and 18 who can speak and read Chinese Fulfil the diagnostic criteria of scoliosis, i.e. Cobb's angle ≥ 10 degree Risser grade ranging from 0 to 4 Informed consent agreement signed by both subject and their parents/guardians Able to participate in follow-up assessments Exclusion Criteria: History of spine surgery; Cobb's angle >30 degrees Known to have severe respiratory or cardiovascular comorbidities; vertebral tumours and spinal canal abnormalities; Leukaemia, thrombocytopenia and other bleeding disorders Known to have cognitive impairment. Documented pregnancy Wearing brace within 1 month. Involved in other interventional clinical studies at the same time. Uncooperative during treatments Being assessed by investigators as unsuitable to participate.

Ages Eligible for Study
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Minimum Age: 10 Years
Maximum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Manipulation Techniques Group<br>Subjects will be received orthopedic manipulation and Physiotherapy Scoliosis-Specific Exercise(PSSE). For orthopedic manipulation, Subjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week. For PSSE, subjects will receive 14 supervise training, 5 times of intensive supervise training for first two weeks and then 1-2 trainings per month for the rest. Subjects are encouraged to perform home exercise everyday on their own throughout the study. | Other: Manipulation Techniques<br>* Subjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week.<br>Other: Physiotherapy Scoliosis-Specific Exercise<br>* Subjects will receive 14 supervise training, 5 times of intensive supervise training for first two weeks and then 1-2 trainings per month for the rest. Subjects are encouraged to perform home exercise everyday on their own throughout the study.<br>|
| Experimental: Control Group<br>Subjects will be received sham orthopedic manipulation and Physiotherapy Scoliosis-Specific Exercise(PSSE). For orthopedic manipulation, Subjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week. For PSSE, subjects will receive 14 supervise training, 5 times of intensive supervise training for first two weeks and then 1-2 trainings per month for the rest. Subjects are encouraged to perform home exercise everyday on their own throughout the study. | Other: Physiotherapy Scoliosis-Specific Exercise<br>* Subjects will receive 14 supervise training, 5 times of intensive supervise training for first two weeks and then 1-2 trainings per month for the rest. Subjects are encouraged to perform home exercise everyday on their own throughout the study.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Scoliosis Research Society-22 (SRS-22) | Scoliosis Research Society-22 (SRS-22) questionnaire includes 5 dimensions : 1)function/activity,2) pain,3) self-perceived image, 4)mental health, satisfaction with treatment and 5)other health-related quality of life(HRQL) parameters with a total of 22 items, and is scored by the Likert 5-level scoring method. Possible score range from 0 (no pain)to 5(worst possible pain).A higher score indicates a better quality of life for the patient. | Baseline, Week 8,16,24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change of Traditional Chinese version of Spinal Appearance Questionnaire score (TC-SAQ) | Spinal Appearance Questionnaire (SAQ) is a questionnaire specifically assess the cosmetic perception of AIS patients. The reliability, validity and responsiveness of SAQ have been demonstrated to be excellent for the assessment of appearance in AIS patients | Baseline, Week 8,16,24 | 
| Change of Cobb's angle measured by Xray | A standing whole-spine PA radiograph will be used for measurement. The measurement method is: 1) identify the most inclined vertebrae in the superior section and draw a perpendicular line. Then, 2) identify the most inclined vertebrae in the inferior section and 3) draw a perpendicular line. The angle formed at the intersection of these two lines is the Cobb's angle. | Baseline, Week 16 | 
| Change of spinal rotation by Ultrasonography | Scolioscan is a validated radiation-free system for scoliosis assessment in clinics by using coronal images of spine generated by a 3D ultrasound volume projection imaging method. Scolioscan Air, a portable device of developed from Scolioscan, can be used to monitor the spinal development during study | Before and after the manipulation with the duration of 16 weeks | 
| Change of muscle volume by Ultrasonography | Scolioscan is a validated radiation-free system for scoliosis assessment in clinics by using coronal images of spine generated by a 3D ultrasound volume projection imaging method. Scolioscan Air, a portable device of developed from Scolioscan, can be used to monitor the spinal development during study | Before and after every manipulation with the treatment duration of 16 weeks | 
| Change of Cobb's angle measured by Ultrasonography | Scolioscan is a validated radiation-free system for scoliosis assessment in clinics by using coronal images of spine generated by a 3D ultrasound volume projection imaging method. Scolioscan Air, a portable device of developed from Scolioscan, can be used to monitor the spinal development during study | Before and after the manipulation with the duration of 16 weeks |