Orthopaedic Manipulation in Treatment of Adolescent Idiopathic Scoliosis

Not Applicable

Not yet recruiting

• Conditions: Adolescent Idiopathic Scoliosis
• Interventions: Other: Manipulation Techniques; Other: Physiotherapy Scoliosis-Specific Exercise

• Registration Number: NCT05639023
• Lead Sponsor: Chinese University of Hong Kong

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.

Study Timeline

• Study First Submitted: 2022-10-26
• Status Verified: 2022-11
• Study First Submitted QC: 2022-11-25
• Last Update Submitted: 2022-11-25
• Study First Posted: 2022-12-06
• Last Update Posted: 2022-12-06
• Study Start: 2022-12-19
• Primary Completion: 2023-12-31
• Study Completion: 2024-07-31

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Manipulation Techniques Group	Physiotherapy Scoliosis-Specific Exercise	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.
Control Group	Physiotherapy Scoliosis-Specific Exercise	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.
Manipulation Techniques Group	Manipulation Techniques	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.

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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