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Orthopaedic Manipulation in Treatment of Adolescent Idiopathic Scoliosis

Primary Purpose

Adolescent Idiopathic Scoliosis

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Manipulation Techniques
Physiotherapy Scoliosis-Specific Exercise
Sponsored by
Chinese University of Hong Kong
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Adolescent Idiopathic Scoliosis

Eligibility Criteria

10 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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 Exclusion Criteria: 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Experimental

    Arm Label

    Manipulation Techniques Group

    Control Group

    Arm Description

    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.

    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.

    Outcomes

    Primary Outcome Measures

    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.

    Secondary Outcome Measures

    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
    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.
    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
    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
    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

    Full Information

    First Posted
    October 26, 2022
    Last Updated
    November 25, 2022
    Sponsor
    Chinese University of Hong Kong
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05639023
    Brief Title
    Orthopaedic Manipulation in Treatment of Adolescent Idiopathic Scoliosis
    Official Title
    The Orthopaedic Manipulation Techniques of the Lin School of Lingnan Region in the Treatment of Adolescent Idiopathic Scoliosis - A Randomized Controlled Study
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    November 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    December 19, 2022 (Anticipated)
    Primary Completion Date
    December 31, 2023 (Anticipated)
    Study Completion Date
    July 31, 2024 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Chinese University of Hong Kong

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. 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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Adolescent Idiopathic Scoliosis

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Manipulation Techniques Group
    Arm Type
    Experimental
    Arm Description
    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.
    Arm Title
    Control Group
    Arm Type
    Experimental
    Arm Description
    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.
    Intervention Type
    Other
    Intervention Name(s)
    Manipulation Techniques
    Intervention Description
    Subjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week.
    Intervention Type
    Other
    Intervention Name(s)
    Physiotherapy Scoliosis-Specific Exercise
    Intervention Description
    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 Measure Information:
    Title
    Change of Scoliosis Research Society-22 (SRS-22)
    Description
    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.
    Time Frame
    Baseline, Week 8,16,24
    Secondary Outcome Measure Information:
    Title
    Change of Traditional Chinese version of Spinal Appearance Questionnaire score (TC-SAQ)
    Description
    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
    Time Frame
    Baseline, Week 8,16,24
    Title
    Change of Cobb's angle measured by Xray
    Description
    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.
    Time Frame
    Baseline, Week 16
    Title
    Change of spinal rotation by Ultrasonography
    Description
    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
    Time Frame
    Before and after the manipulation with the duration of 16 weeks
    Title
    Change of muscle volume by Ultrasonography
    Description
    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
    Time Frame
    Before and after every manipulation with the treatment duration of 16 weeks
    Title
    Change of Cobb's angle measured by Ultrasonography
    Description
    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
    Time Frame
    Before and after the manipulation with the duration of 16 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    10 Years
    Maximum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    Inclusion Criteria: 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 Exclusion Criteria: 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.
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Kiu Lam Chung
    Phone
    39433146
    Email
    drchungkl@cuhk.edu.hk
    First Name & Middle Initial & Last Name or Official Title & Degree
    Hing Yu Hung
    Phone
    39439475
    Email
    adahung@cuhk.edu.hk

    12. IPD Sharing Statement

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    Orthopaedic Manipulation in Treatment of Adolescent Idiopathic Scoliosis

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