Orthopaedic Manipulation in Treatment of Adolescent Idiopathic Scoliosis

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

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

Study Overview

• Status: Not yet recruiting
• Conditions: Adolescent Idiopathic Scoliosis
• Intervention / Treatment: Other: Manipulation Techniques; Other: Physiotherapy Scoliosis-Specific Exercise

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 Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kiu Lam Chung; Phone Number: 39433146; Email: drchungkl@cuhk.edu.hk
• Study Contact Backup: Name: Hing Yu Hung; Phone Number: 39439475; Email: adahung@cuhk.edu.hk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 10 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Manipulation Techniques Group; 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; Subjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week.; Other: 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.
Experimental: Control Group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Chinese University of Hong Kong

Study record dates

Study Major Dates

• Study Start (Anticipated): December 19, 2022
• Primary Completion (Anticipated): December 31, 2023
• Study Completion (Anticipated): July 31, 2024

Study Registration Dates

• First Submitted: October 26, 2022
• First Submitted That Met QC Criteria: November 25, 2022
• First Posted (Estimate): December 6, 2022

Study Record Updates

• Last Update Posted (Estimate): December 6, 2022
• Last Update Submitted That Met QC Criteria: November 25, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Spinal Diseases; Bone Diseases; Spinal Curvatures; Scoliosis
• Other Study ID Numbers: 2022.353

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No