Orthopaedic Manipulation in Treatment of Adolescent Idiopathic Scoliosis

NCT ID: NCT05639023

Last Updated: 2022-12-06

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-19
• Study Completion Date: 2024-07-31

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.

Conditions

Adolescent Idiopathic Scoliosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: EXPERIMENTAL

Manipulation Techniques

Intervention Type: OTHER

Subjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week.

Physiotherapy Scoliosis-Specific Exercise

Intervention Type: OTHER

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

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.

Group Type: EXPERIMENTAL

Physiotherapy Scoliosis-Specific Exercise

Intervention Type: OTHER

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.

Interventions

Manipulation Techniques

Subjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week.

Intervention Type: 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.

Intervention Type: OTHER

Eligibility 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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Chinese University of Hong Kong

OTHER

Sponsor Role: lead

Responsible Party

Kiu Lam Chung

Associate Professor of Practice in Chinese Medicine

Responsibility Role: PRINCIPAL_INVESTIGATOR

Central Contacts

Kiu Lam Chung

Role: CONTACT

drchungkl@cuhk.edu.hk

39433146

Hing Yu Hung

Role: CONTACT

adahung@cuhk.edu.hk

39439475

References

Hung HY, Kong WC, Tam TH, Leung PC, Zheng Y, Wong AYL, Lin Z, Yao F, Tian Q, Mok TL, Loo LE, Chung KL. Efficacy and safety of the orthopaedic manipulation techniques of the Lin School of Lingnan Region in the treatment of adolescent idiopathic scoliosis: protocol of a participant-and-assessor-blinded randomized controlled study. BMC Musculoskelet Disord. 2024 Jan 4;25(1):32. doi: 10.1186/s12891-023-07152-9.

Reference Type: DERIVED

PMID: 38178051 (View on PubMed)

Other Identifiers

2022.353

Identifier Type: -

Identifier Source: org_study_id