Orthopaedic Manipulation in Treatment of Adolescent Idiopathic Scoliosis

• ClinicalTrials.gov Identifier: NCT05639023
• Recruitment Status: Not yet recruiting
• First Posted: December 6, 2022
• Last Update Posted: December 6, 2022
• Sponsor: Chinese University of Hong Kong
• Information provided by (Responsible Party): Kiu Lam Chung, Chinese University of Hong Kong

Study Description

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

Condition or disease	Intervention/treatment	Phase
Adolescent Idiopathic Scoliosis	Other: Manipulation Techniques; Other: Physiotherapy Scoliosis-Specific Exercise	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Treatment
• Official Title: The Orthopaedic Manipulation Techniques of the Lin School of Lingnan Region in the Treatment of Adolescent Idiopathic Scoliosis - A Randomized Controlled Study
• Estimated Study Start Date: December 19, 2022
• Estimated Primary Completion Date: December 31, 2023
• Estimated Study Completion Date: July 31, 2024

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures :

1. Change of Scoliosis Research Society-22 (SRS-22) [ Time Frame: 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 :

1. Change of Traditional Chinese version of Spinal Appearance Questionnaire score (TC-SAQ) [ Time Frame: 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
2. Change of Cobb's angle measured by Xray [ Time Frame: 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.
3. Change of spinal rotation by Ultrasonography [ Time Frame: 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
4. Change of muscle volume by Ultrasonography [ Time Frame: 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
5. Change of Cobb's angle measured by Ultrasonography [ Time Frame: 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

Eligibility Criteria

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

Criteria

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.

Contacts and Locations

Contacts

Contact: Kiu Lam Chung; 39433146; drchungkl@cuhk.edu.hk

Contact: Hing Yu Hung; 39439475; adahung@cuhk.edu.hk

Sponsors and Collaborators

Chinese University of Hong Kong

More Information

• Responsible Party: Kiu Lam Chung, Associate Professor of Practice in Chinese Medicine, Chinese University of Hong Kong
• ClinicalTrials.gov Identifier: NCT05639023
• Other Study ID Numbers: 2022.353
• First Posted: December 6, 2022
• Last Update Posted: December 6, 2022
• Last Verified: November 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Scoliosis; Spinal Curvatures; Spinal Diseases; Bone Diseases; Musculoskeletal Diseases