Orthopaedic Manipulation in Treatment of Adolescent Idiopathic Scoliosis

NCT05639023 | Unknown

• 1 other identifier: 2022.353
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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

Conditions

Adolescent Idiopathic Scoliosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Change of Traditional Chinese version of Spinal Appearance Questionnaire score (TC-SAQ)

  Baseline, Week 8,16,24

• Change of Cobb's angle measured by Xray

  Baseline, Week 16

• Change of spinal rotation by Ultrasonography

  Before and after the manipulation with the duration of 16 weeks

• Change of muscle volume by Ultrasonography

  Before and after every manipulation with the treatment duration of 16 weeks

• Change of Cobb's angle measured by Ultrasonography

  Before and after the manipulation with the duration of 16 weeks

Study Arms (2)

Manipulation Techniques Group

EXPERIMENTAL

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; Other: Physiotherapy Scoliosis-Specific Exercise

Control Group

EXPERIMENTAL

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

Interventions

Manipulation Techniques OTHER

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

Manipulation Techniques Group

Physiotherapy Scoliosis-Specific Exercise 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; Manipulation Techniques Group

Eligibility Criteria

• Age: 10 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Adolescents aged between 10 and 18 who can speak and read Chinese
• Fulfil the diagnostic criteria of scoliosis, i.e. Cobb's angle ≥ 10 degree
• Risser grade ranging from 0 to 4
• Informed consent agreement signed by both subject and their parents/guardians
• Able to participate in follow-up assessments

You may not qualify if:

• History of spine surgery;
• Cobb's angle \>30 degrees
• Known to have severe respiratory or cardiovascular comorbidities; vertebral tumours and spinal canal abnormalities; Leukaemia, thrombocytopenia and other bleeding disorders
• Known to have cognitive impairment.
• Documented pregnancy
• Wearing brace within 1 month.
• Involved in other interventional clinical studies at the same time.
• Uncooperative during treatments
• Being assessed by investigators as unsuitable to participate.

Sponsors & Collaborators

• Chinese University of Hong Kong: lead

Related Publications (1)

• 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.

  PMID: 38178051 DERIVED

Central Study Contacts

Kiu Lam Chung

CONTACT

39433146; drchungkl@cuhk.edu.hk

Hing Yu Hung

CONTACT

39439475; adahung@cuhk.edu.hk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Practice in Chinese Medicine

Study Record Dates

• First Submitted: October 26, 2022
• First Posted: December 6, 2022
• Study Start: December 19, 2022
• Primary Completion: December 31, 2023
• Study Completion: July 31, 2024
• Last Updated: December 6, 2022

Record last verified: 2022-11