Adolescent Idiopathic Scoliosis
Conditions
Brief summary
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
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.
Interventions
OTHERManipulation Techniques
Subjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week.
OTHERPhysiotherapy Scoliosis-Specific Exercise
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.
Sponsors
Chinese University of Hong Kong
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
10 Years to 18 Years
Healthy volunteers
No
Inclusion criteria
1. Adolescents aged between 10 and 18 who can speak and read Chinese 2. Fulfil the diagnostic criteria of scoliosis, i.e. Cobb's angle ≥ 10 degree 3. Risser grade ranging from 0 to 4 4. Informed consent agreement signed by both subject and their parents/guardians 5. Able to participate in follow-up assessments
Exclusion criteria
1. History of spine surgery; 2. Cobb's angle \>30 degrees 3. Known to have severe respiratory or cardiovascular comorbidities; vertebral tumours and spinal canal abnormalities; Leukaemia, thrombocytopenia and other bleeding disorders 4. Known to have cognitive impairment. 5. Documented pregnancy 6. Wearing brace within 1 month. 7. Involved in other interventional clinical studies at the same time. 8. Uncooperative during treatments 9. Being assessed by investigators as unsuitable to participate.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change of Scoliosis Research Society-22 (SRS-22) | Baseline, Week 8,16,24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change of Traditional Chinese version of Spinal Appearance Questionnaire score (TC-SAQ) | Baseline, Week 8,16,24 | 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 |
| Change of Cobb's angle measured by Xray | Baseline, Week 16 | 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. |
| Change of spinal rotation by Ultrasonography | Before and after the manipulation with the duration of 16 weeks | 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 |
| Change of muscle volume by Ultrasonography | Before and after every manipulation with the treatment duration of 16 weeks | 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 |
| Change of Cobb's angle measured by Ultrasonography | Before and after the manipulation with the duration of 16 weeks | 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 |
Contacts
Primary ContactKiu Lam Chung
Backup ContactHing Yu Hung
Outcome results
None listed