Scoliosis Idiopathic AdolescentNCT02968043
Efficacy of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis
A study testing physiotherapeutic scoliosis specific exercises and generalised physiotherapy exercises in people with Scoliosis Idiopathic Adolescent, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
Trial summary
Adolescent idiopathic scoliosis (AIS) has a relatively high prevalence in adolescents. Exercise is the most common conservative therapy for mild AIS patients. There are increasing evidences suggesting that physiotherapeutic scoliosis specific exercise (PSSE) can halt the curve progression. Read more about this study
- Who is it for?
- Ages 10 to 16 years
- Conditions the study is for
- Scoliosis Idiopathic Adolescent
- What is being tested?
- physiotherapeutic scoliosis specific exercises and generalised physiotherapy exercises
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 2 sitesChina
- Study dates
- 1 Feb 2017to 31 Dec 2021
- 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 16 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- patients who are consistent with the diagnosis of adolescent idiopathic scoliosis suggested by Scoliosis Research Society
- the largest Cobb angle of less than 20 degrees on whole spine posterior-anterior X-ray radiographs in a standing position
- 10 to 16 years old
- skeletal immaturity with Risser sign of <3
Who cannot join
- previous exercises or brace treatment history
- previous operation history of spine or lower extremities
- scoliosis caused by neuromuscular disorder, vertebral malformation, trauma, tumor, or other diseases
- having contraindications to exercises
Trial locations and contacts
2 sites in 1 country.
China2 sites
Xin Hua Hospital affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
Xinhua Hospital Chongming Branch
Shanghai, Shanghai Municipality, 202150
About this study
Official title: Application Research of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis
Adolescent idiopathic scoliosis (AIS) has a relatively high prevalence in adolescents. Exercise is the most common conservative therapy for mild AIS patients. There are increasing evidences suggesting that physiotherapeutic scoliosis specific exercise (PSSE) can halt the curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality. The aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle, fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for mild AIS patients, and to promote PSSE's application in Shanghai.
Prior to inclusion, all subjects will be examined by the physiatrists. A parent of each subject will be asked to sign an informed consent form before the subject participate in the study.
Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the intervention group, in which they will perform PSSEs; or the control group, in which they will perform generalised physiotherapy exercises. All subjects will be assessed at the initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic appearance, radiographic measurement, static balance test, pulmonary function test, bone quality, and HRQoL will be used.
Read the detailed description
Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional deformity of the spinal column, including scoliosis in the coronal plane, fixed rotation of the vertebral body and physiological curvature loss in the sagittal plane. AIS has a relatively high prevalence in adolescents. Exercise is the most common conservative therapy for mild AIS patients and has been widely used to reduce spinal deformity and halt curve progression. There are two kinds of exercises: generalised physiotherapy exercises and physiotherapeutic scoliosis specific exercise (PSSE). Little evidence is in favor of generalised physiotherapy exercises. There are increasing evidences suggesting that PSSE can halt the curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality. Thus, the aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle, fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for mild AIS patients, and to promote PSSE's application in Shanghai.
The AIS patients will be recruited from and investigated at the Xinhua Hospital, Xinhua Hospital Chongming Branch, Shanghai First Rehabilitation Hospital, Shanghai Yangzhi Rehabilitation Hospital, and Shanghai Yangpu Daqiao Community Health Service Centre. Prior to inclusion, all subjects will be examined by the physiatrists. The subjects' height, weight, shoulder, chest, back and pelvic asymmetries, and the Adams forward bend test will be evaluated and recorded. The following information will be obtained for all subjects, including demographic data (for example, age and sex), menarche status for the girls, and family history. A parent of each subject will be asked to sign an informed consent form before the subject participate in the study.
Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the intervention group, in which they will perform PSSEs under the guidance of an experienced physiotherapist with expertise in scoliosis in an outpatient clinic; or the control group, in which they will perform generalised physiotherapy exercises. All subjects will receive the treatment as allocated and will be assessed at the initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic appearance, radiographic measurement, static balance test, pulmonary function test, bone quality, and HRQoL will be used.
- Conditions
- Scoliosis Idiopathic Adolescent
- Being tested
- physiotherapeutic scoliosis specific exercises, generalised physiotherapy exercises
- Keywords
- physiotherapeutic scoliosis specific exercise
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
physiotherapeutic scoliosis specific exercisesOther
Physiotherapeutic scoliosis specific exercises (PSSE) is recommended as a first step in the treatment of AIS to halt curve progression by SOSORT guidelines. The PSSE program will be personalized according to the subject's curves characteristics. The program includes patient and family education, 3D self-correction, stabilizing exercises, balance training, breathing exercises, and training in activities of daily living. A physiatrist will give a detailed explanation of the aims, importance, methods, and procedure of an intervention to patients and their parents. Each subject will receive guidance from multiple physiotherapists to ensure that the treatment effects are the result of the protocol and not any particular physiotherapists.
generalised physiotherapy exercisesOther
Generalised physiotherapy exercises includes stretching and strengthening activities. Little evidence is in favor of generalised physiotherapy exercises. Each subject will receive guidance from multiple physiotherapists.
| Study group | Role | What they receive |
|---|---|---|
| control group | Active comparator | Control group will perform generalised physiotherapy exercises for a 60-min period for 2 or 3 times a week under the guidance of experienced physiotherapists in an outpatient clinic and for a 20-min period per day under the supervision of the parents at home. Generalised physiotherapy exercises consist of stretching and strengthening activities. Receives: Other: generalised physiotherapy exercises |
| intervention group | Experimental | Intervention group will perform physiotherapeutic scoliosis specific exercises for a 60-min period for 2 or 3 times a week under the guidance of experienced physiotherapists with expertise in scoliosis in an outpatient clinic and for a 20-min period per day under the supervision of the parents at home. Physiotherapeutic scoliosis specific exercises consist of patient and family education, 3D self-correction, stabilizing exercises, balance training, breathing exercises, and training in activities of daily living. Receives: Other: physiotherapeutic scoliosis specific exercises |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline Cobb's Angle at 6 months
Cobb's angle is the "gold standard" measurement on the frontal plane. The standing full spine posterior-anterior X-ray radiograph will be taken at the initial visit and 6 months later.
Measured: up to 6 months
Secondary outcomes (6)
Rotation Angle of Apical Vertebral
Rotation angle of apical vertebral will be measured by Nash Moe rotation at the initial visit and 6 months later.
Measured: up to 6 months
Change from Baseline Fall Index at 6 months
Static balance test will be performed at the initial visit and 6 months later. Fall index will be caculated. Fall index scores from 0 to 100. The higher the fall index the higher the risk of fall.
Measured: up to 6 months
Change from Baseline Forced Vital Capacity at 6 months
Pulmonary function test will be tested at the initial visit and 6 months later. Forced vital capacity will be measured.
Measured: up to 6 months
Change from Baseline Forced Expiratory Volume in First Second at 6 months
Pulmonary function test will be tested at the initial visit and 6 months later. Forced expiratory volume in first second will be measured.
Measured: up to 6 months
Change from Baseline Nondominant Radius Speed of Sound at 6 months
Bone quality will be measured using a quantitative ultrasound machine (Omnisense 7000P, Sunlight Medical Inc, Israel) at the initial visit and 6 months later. The quantitative ultrasound method can measure speed of sound (SOS) at the distal 1/3 of the radius by axial transmission. The measurement site is defined as the distal 1/3 of the radius. The mean of three measurements of the radius SOS is used for analysis.
Measured: up to 6 months
Scores of Scoliosis Research Society-22 Questionnaire
Scoliosis Research Society-22 questionnaire (SRS-22) scores will be evaluated using the Chinese version of SRS-22 at the initial visit and 6 months later. All subjects will be required to complete SRS-22 independently. SRS-22 is a simple form of questionnaire to assess the HRQoL of AIS patients. It consists of 22 questions in 5 domains including functional activity, pain, self-image, psychological heath and satisfaction to treatment. Each question scores from 1 point (the lowest) to 5 (the highest). Each domain scores from 5 points to 25 points except for satisfaction to the treatment, which scores from 2 points to 10 points. Each domain is expressed as a mean value: the higher the score the better the outcome.
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Nov 2016 (estimated)
- Study start1 Feb 2017
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Scoliosis Idiopathic AdolescentStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe 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
- Outcomes assessor
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Xinhua Hospital Chongming Branch, Shanghai First Rehabilitation Hospital, Shanghai Sunshine Rehabilitation Center, Shanghai Yangpu Daqiao Community Health Service Center
- Responsible party
- Principal investigator, Qing Du, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
- Investigators
- Qing Du, Ph.D, Principal investigator, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02968043
- Sponsor's protocol ID
- XH-16-041
- Status last verified
- Aug 2026
- First submitted
- 11 Nov 2016
- Last updated
- 4 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Application Research of Physiotherapeutic Scoliosis Specific Exercises in Adolescent Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT02968043
- Acronym / sponsor ID
- XH-16-041
- Conditions
- Scoliosis Idiopathic Adolescent
- Keywords
- physiotherapeutic scoliosis specific exercise
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Collaborators
- Xinhua Hospital Chongming Branch, Shanghai First Rehabilitation Hospital, Shanghai Sunshine Rehabilitation Center, Shanghai Yangpu Daqiao Community Health Service Center
- Study start
- 1 Feb 2017 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 18 Nov 2016 (estimated)
- 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.
Adolescent idiopathic scoliosis (AIS) has a relatively high prevalence in adolescents. Exercise is the most common conservative therapy for mild AIS patients. There are increasing evidences suggesting that physiotherapeutic scoliosis specific exercise (PSSE) can halt the curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality. The aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle, fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for mild AIS patients, and to promote PSSE's application in Shanghai.
Prior to inclusion, all subjects will be examined by the physiatrists. A parent of each subject will be asked to sign an informed consent form before the subject participate in the study.
Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the intervention group, in which they will perform PSSEs; or the control group, in which they will perform generalised physiotherapy exercises. All subjects will be assessed at the initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic appearance, radiographic measurement, static balance test, pulmonary function test, bone quality, and HRQoL will be used.
Detailed description
Adolescent idiopathic scoliosis (AIS) is a complex three-dimensional deformity of the spinal column, including scoliosis in the coronal plane, fixed rotation of the vertebral body and physiological curvature loss in the sagittal plane. AIS has a relatively high prevalence in adolescents. Exercise is the most common conservative therapy for mild AIS patients and has been widely used to reduce spinal deformity and halt curve progression. There are two kinds of exercises: generalised physiotherapy exercises and physiotherapeutic scoliosis specific exercise (PSSE). Little evidence is in favor of generalised physiotherapy exercises. There are increasing evidences suggesting that PSSE can halt the curve progression. Nevertheless, the evidence concerning PSSE is inadequate and low quality. Thus, the aim of this study is to identify the efficacy of PSSE on Cobb's angle, rotation angle, fall index, pulmonary function, bone quality, and health related quality-of-life (HRQoL) for mild AIS patients, and to promote PSSE's application in Shanghai.
The AIS patients will be recruited from and investigated at the Xinhua Hospital, Xinhua Hospital Chongming Branch, Shanghai First Rehabilitation Hospital, Shanghai Yangzhi Rehabilitation Hospital, and Shanghai Yangpu Daqiao Community Health Service Centre. Prior to inclusion, all subjects will be examined by the physiatrists. The subjects' height, weight, shoulder, chest, back and pelvic asymmetries, and the Adams forward bend test will be evaluated and recorded. The following information will be obtained for all subjects, including demographic data (for example, age and sex), menarche status for the girls, and family history. A parent of each subject will be asked to sign an informed consent form before the subject participate in the study.
Eligible subjects will be randomized by a 1:1 allocation ratio by computer either to the intervention group, in which they will perform PSSEs under the guidance of an experienced physiotherapist with expertise in scoliosis in an outpatient clinic; or the control group, in which they will perform generalised physiotherapy exercises. All subjects will receive the treatment as allocated and will be assessed at the initial visit and 6 months. A multidimensional, comprehensive evaluation including aesthetic appearance, radiographic measurement, static balance test, pulmonary function test, bone quality, and HRQoL will be used.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Active comparator | Other: generalised physiotherapy exercisesControl group will perform generalised physiotherapy exercises for a 60-min period for 2 or 3 times a week under the guidance of experienced physiotherapists in an outpatient clinic and for a 20-min period per day under the supervision of the parents at home. Generalised physiotherapy exercises consist of stretching and strengthening activities. |
| intervention group | Experimental | Other: physiotherapeutic scoliosis specific exercisesIntervention group will perform physiotherapeutic scoliosis specific exercises for a 60-min period for 2 or 3 times a week under the guidance of experienced physiotherapists with expertise in scoliosis in an outpatient clinic and for a 20-min period per day under the supervision of the parents at home. Physiotherapeutic scoliosis specific exercises consist of patient and family education, 3D self-correction, stabilizing exercises, balance training, breathing exercises, and training in activities of daily living. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- patients who are consistent with the diagnosis of adolescent idiopathic scoliosis suggested by Scoliosis Research Society
- the largest Cobb angle of less than 20 degrees on whole spine posterior-anterior X-ray radiographs in a standing position
- 10 to 16 years old
- skeletal immaturity with Risser sign of <3
Key exclusion criteria (4 listed)
- previous exercises or brace treatment history
- previous operation history of spine or lower extremities
- scoliosis caused by neuromuscular disorder, vertebral malformation, trauma, tumor, or other diseases
- having contraindications to exercises
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 |
|---|---|---|
| physiotherapeutic scoliosis specific exercisesPhysiotherapeutic scoliosis specific exercises (PSSE) is recommended as a first step in the treatment of AIS to halt curve progression by SOSORT guidelines. The PSSE program will be personalized according to the subject's curves characteristics. The program includes patient and family education, 3D self-correction, stabilizing exercises, balance training, breathing exercises, and training in activities of daily living. A physiatrist will give a detailed explanation of the aims, importance, methods, and procedure of an intervention to patients and their parents. Each subject will receive guidance from multiple physiotherapists to ensure that the treatment effects are the result of the protocol and not any particular physiotherapists. | Other | intervention group |
| generalised physiotherapy exercisesGeneralised physiotherapy exercises includes stretching and strengthening activities. Little evidence is in favor of generalised physiotherapy exercises. Each subject will receive guidance from multiple physiotherapists. | Other | control group |
Primary outcome
Change from Baseline Cobb's Angle at 6 months
Time frame: up to 6 months
Cobb's angle is the "gold standard" measurement on the frontal plane. The standing full spine posterior-anterior X-ray radiograph will be taken at the initial visit and 6 months later.
6 secondary outcomes
Rotation Angle of Apical Vertebral
Time frame: up to 6 months
Change from Baseline Fall Index at 6 months
Time frame: up to 6 months
Change from Baseline Forced Vital Capacity at 6 months
Time frame: up to 6 months
Change from Baseline Forced Expiratory Volume in First Second at 6 months
Time frame: up to 6 months
Change from Baseline Nondominant Radius Speed of Sound at 6 months
Time frame: up to 6 months
Scores of Scoliosis Research Society-22 Questionnaire
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Aug 2026.
- Individual participant dataSharing planned: No
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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.
Qing Du, Ph.D principal investigator
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing physiotherapeutic scoliosis specific exercises and generalised physiotherapy exercises in people with Scoliosis Idiopathic Adolescent, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 2 sites in China.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline Cobb's Angle at 6 months (time frame: up to 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Aug 2026.