Adolescent Idiopathic ScoliosisNCT05639023
Orthopaedic Manipulation in Treatment of Adolescent Idiopathic Scoliosis
A study testing Manipulation Techniques and Physiotherapy Scoliosis-Specific Exercise in people with Adolescent Idiopathic Scoliosis, run by Chinese University of Hong Kong.
Trial 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 Read more about this study
- Who is it for?
- Ages 10 to 18 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Manipulation Techniques and Physiotherapy Scoliosis-Specific Exercise
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 19 Dec 2022to 31 Jul 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 9Show fewer
- Involved in other interventional clinical studies at the same time.
- Uncooperative during treatments
- Being assessed by investigators as unsuitable to participate.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
Read the 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
- Being tested
- Manipulation Techniques, Physiotherapy Scoliosis-Specific Exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Manipulation TechniquesOther
Subjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week.
Physiotherapy Scoliosis-Specific ExerciseOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: Physiotherapy Scoliosis-Specific Exercise |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 8,16,24
Secondary outcomes (5)
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
Measured: 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.
Measured: 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
Measured: 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
Measured: 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
Measured: Before and after the manipulation with the duration of 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Dec 2022
- Study start19 Dec 2022 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion31 Jul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Chinese University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chinese University of Hong Kong
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kiu Lam Chung, Chinese University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05639023
- Sponsor's protocol ID
- 2022.353
- Status last verified
- Nov 2022
- First submitted
- 26 Oct 2022
- Last updated
- 6 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 38178051
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Orthopaedic Manipulation Techniques of the Lin School of Lingnan Region in the Treatment of Adolescent Idiopathic Scoliosis - A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT05639023
- Acronym / sponsor ID
- 2022.353
- Conditions
- Adolescent Idiopathic Scoliosis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Chinese University of Hong KongUniversity, hospital or other
- Study start
- 19 Dec 2022 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 31 Jul 2024 (estimated)
- First posted
- 6 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Manipulation Techniques Group | Experimental | Other: Manipulation Techniques, Other: Physiotherapy Scoliosis-Specific ExerciseSubjects 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. |
| Control Group | Experimental | Other: Physiotherapy Scoliosis-Specific ExerciseSubjects 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. |
Who may qualify
- Ages
- 10 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Manipulation TechniquesSubjects will received 12 times orthopedic manipulation. Three times of treatment per months, and less than twice a week. | Other | Manipulation Techniques Group |
| Physiotherapy Scoliosis-Specific ExerciseSubjects 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 | Control Group, Manipulation Techniques Group |
Primary outcome
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.
5 secondary outcomes
Change of Traditional Chinese version of Spinal Appearance Questionnaire score (TC-SAQ)
Time frame: Baseline, Week 8,16,24
Change of Cobb's angle measured by Xray
Time frame: Baseline, Week 16
Change of spinal rotation by Ultrasonography
Time frame: Before and after the manipulation with the duration of 16 weeks
Change of muscle volume by Ultrasonography
Time frame: Before and after every manipulation with the treatment duration of 16 weeks
Change of Cobb's angle measured by Ultrasonography
Time frame: Before and after the manipulation with the duration of 16 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2022.
- Derived from this study: PubMed 38178051Hung 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.
Related trials for Adolescent Idiopathic Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis
Recruiting
Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
Scoliosis Idiopathic, Scoliosis; Adolescence
RecruitingObservational study
Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Not yet recruitingObservational study
Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
Adolescent Idiopathic Scoliosis (AIS)
Recruiting
Studying Melatonin and Recovery in Teens
Juvenile; Scoliosis, Scoliosis Idiopathic
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Manipulation Techniques and Physiotherapy Scoliosis-Specific Exercise in people with Adolescent Idiopathic Scoliosis, run by Chinese University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kiu Lam Chung (39433146, drchungkl@cuhk.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change of Scoliosis Research Society-22 (SRS-22) (time frame: Baseline, Week 8,16,24). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05639023, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2022.