Orthopaedic Manipulation in Treatment of Adolescent Idiopathic Scoliosis

Adolescent Idiopathic Scoliosis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05639023
• Other study ID #: 2022.353
• Status: Not yet recruiting
• Phase: N/A
• Start date: December 19, 2022
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2022
• Source: Chinese University of Hong Kong
• Contact: Kiu Lam Chung
• Phone: 39433146
• Email: drchungkl[@]cuhk.edu.hk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: July 31, 2024
• Est. primary completion date: December 31, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years to 18 Years

Eligibility

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.

Related Conditions & MeSH terms

• Adolescent Idiopathic Scoliosis
• Scoliosis

Intervention

Other:
• Manipulation Techniques
Subjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week.
• Physiotherapy 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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Chinese University of Hong Kong

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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