Adolescent Idiopathic ScoliosisNCT03305185
Efficacy of Scoliosis Specific Exercise in Patients With Adolescent Idiopathic Scoliosis During Bracing
A study testing Schroth SSE with Bracing and Bracing alone in people with Adolescent Idiopathic Scoliosis, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
The purpose of this study is to examine the effectiveness of Schroth scoliosis-specific exercises (SSE) on patients with adolescent idiopathic scoliosis (AIS) during bracing. The goal is to determine if Schroth SSE combined with bracing can is superior in controlling curve progression when compared with bracing alone. Read more about this study
- Who is it for?
- Ages 10 to 15 years
- Conditions the study is for
- Adolescent Idiopathic Scoliosis
- What is being tested?
- Schroth SSE with Bracing and Bracing alone
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 98 participants
- Where
- 1 siteHong Kong
- Study dates
- 18 Dec 2017to 30 Jun 2023
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of AIS
- Male or female from 10 to 15 year-old, inclusive, at the time of consent provided
- Skeletal immaturity, defined as a Risser grade (amount of ossification and eventual fusion of the iliac apophysis) of 0, 1, or 2
- Cobb angle of 25-40
- No prior conservative or surgical treatment for AIS
Who cannot join
- An underlying cause or association that may cause scoliosis
- Leg length discrepancies or lower limb deformities that may interfere with spinal posture
- Previous spinal surgery
- Cognitive impairment
- Those receiving any other forms of treatment including alternative medicine for the treatment of their scoliosis
- Those who are unable to return for follow-up to complete the trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy of Scoliosis Specific Exercise (SSE) in Patients With Adolescent Idiopathic Scoliosis (AIS) During Bracing: A Randomized Controlled Clinical Trial
The purpose of this study is to examine the effectiveness of Schroth scoliosis-specific exercises (SSE) on patients with adolescent idiopathic scoliosis (AIS) during bracing. The goal is to determine if Schroth SSE combined with bracing can is superior in controlling curve progression when compared with bracing alone. Curve progression is defined as worsening of coronal Cobb angle of 6 degrees or more.
Read the detailed description
Adolescent Idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine, characterized by a lateral curvature and vertebral rotation. Its prevalence is estimated to be 2.5% in children between aged 10 and 16 in Hong Kong. Curve progression occurs during pubertal growth spurt. If the primary curve does not exceed 40 degree at skeletal maturity, it is unlikely to continue to progress, and there are little or no long-term clinical consequences. However, if the curve progresses beyond 50 degree during adolescence, it may cause functional limitation, accelerated disc degeneration with potential neurological deficit, cosmetic concerns, decreased quality of life, and possible progression in adulthood. Thus, surgical correction of the deformity with instrumented spinal fusion is usually recommended if the curve reaches 50 degree during adolescence.
Currently, spinal bracing is the only the only non-operative treatment supported with high-quality evidence that can prevent curve progression. In a randomized controlled trial, Weinstein et al. recently reported in the New England Journal of Medicine that bracing was effective in preventing curve progression to threshold for surgery in 72% of cases. The trial was terminated early due to the treatment benefit in favor of bracing. Nonetheless, the authors reported a treatment failure rate of 25% in the randomized cohort, which was similar to previous published studies. Hence, despite the best available non-operative treatment, the number of adolescents ultimately requiring surgery remains substantial. Surgery is associated with medical comorbidities, can cause psychosocial stress to the children and their families, and has significant financial impact on healthcare, with the total costs of spinal surgery to correct AIS ranked second only to appendicitis among children 10 to 17 years of age. Consequently, further effective strategies to prevent scoliosis progression in children are needed.
Scoliosis-specific exercise (SSE) has been proposed as an additional non-operative intervention that may reduce curve progression during the adolescent growth spurt. However, the standard of care for non-operative treatment of AIS varies widely between North America and Europe, and the use of SSE is not universally accepted. SSE is a potentially low-cost intervention that will be of substantial benefit even if a relative risk reduction in curve progression or reaching the threshold for surgery is reduced in a modest proportion of those participating.
SSE, as opposed to generalized physiotherapy, consists of individually-adapted exercises that aim to promote spinal realignment through self-correction and stabilization, as well as modulating patterns of trunk muscles recruitment. Electromyography (EMG) of paraspinal and abdominal muscles in AIS patients revealed disrupted patterns of muscles recruitment, which are associated with a disparity in trunk isometric rotation strength between sides. AIS patients demonstrate proprioceptive and balance control problems, along with a distorted body schema, resulting in a mismatch between the actual spinal alignment and the patients' internal representation of the body. SSE aims to reverse the anomalous patterns of muscle recruitment through training, and modify the body schema with visual and somatosensory feedback. This forms the theoretical neurophysiological basis for using this treatment strategy for AIS.
Schroth SSE is one of the most studied and widely-used schools of SSE. It is a technique tailored to the type of scoliosis and the curve magnitude of each patient. It is based on vertebrae deflections and sagittal corrections that result in horizontal vertebrae de-rotation. It uses rotational breathing and postural auto-correction to reverse the underlying impairments in spinal muscle function, postural control and proprioception which contribute to the development of curvature in AIS. Patients will also be given cognitive behavioral strategies to empower them to self-manage their conditions.
- Conditions
- Adolescent Idiopathic Scoliosis
- Being tested
- Schroth SSE with Bracing, Bracing alone
- Keywords
- AIS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Schroth SSE with BracingCombination product
Patients in this group will be prescribed an outpatient-based Schroth exercise program, as per our preliminary study. It consists of an individualised eight-week outpatient program that includes four initial private training sessions, once every two weeks, where exercises will be taught to the patient and their caregivers. A home exercise program will be instituted thereafter and patients will be required to return for supervised sessions once every two months.
Bracing aloneDevice
Patients in the control group will receive standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will only attend study assessments with no extra physiotherapy sessions.
| Study group | Role | What they receive |
|---|---|---|
| Schroth SSE with Bracing | Experimental | Patients in this group will be prescribed an outpatient-based Schroth exercise program, as per our preliminary study. It consists of an individualised eight-week outpatient program that includes four initial private training sessions, once every two weeks, where exercises will be taught to the patient and their caregivers. A home exercise program will be instituted thereafter and patients will be required to return for supervised sessions once every two months. Receives: Combination Product: Schroth SSE with Bracing |
| Bracing alone | Active comparator | Patients in the control group will receive standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will only attend study assessments with no extra physiotherapy sessions. Receives: Device: Bracing alone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Effect of Schroth SSE during bracing versus bracing alone in AIS patients as determined by the difference in coronal Cobb angle pre- and one year post-treatment
- To evaluate the effect of Schroth SSE during bracing versus bracing alone in AIS patients as determined by the difference in coronal Cobb angle pre- and one year post-treatment
Measured: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Secondary outcomes (9)
Compare changes in sagittal plane radiological parameter between Schroth SSE with bracing and bracing alone by EOS Imaging System
To evaluate the effect of Schroth SSE during bracing compared with bracing alone on sagittal plane radiological parameter using EOS Imaging System
Measured: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Compare changes in transverse plane radiological parameter between Schroth SSE with bracing and bracing alone by EOS Imaging System
To evaluate the effect of Schroth SSE during bracing compared with bracing alone on transverse plane radiological parameter using EOS Imaging System
Measured: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Compare changes in surface topography between Schroth SSE with bracing and bracing alone using Bunnell's scoliometer
To evaluate the effect of Schroth SSE during bracing compared with bracing alone on surface topography using Bunnell's scoliometer
Measured: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Compare changes in surface topography between Schroth SSE with bracing and bracing alone using clinical photography
To evaluate the effect of Schroth SSE during bracing compared with bracing alone on surface topography using clinical photography
Measured: baseline, 6 months, 12 months, until skeletal maturity
Compare changes in surface topography between Schroth SSE with bracing and bracing alone using VITUS Smart XXL 3D body scanner system
To evaluate the effect of Schroth SSE during bracing compared with bracing alone on surface topography using VITUS Smart XXL 3D body scanner system
Measured: baseline, 6 months, 12 months, until skeletal maturity
Measure quality of life between Schroth SSE with underarm brace and underarm brace alone by SRS-7 questionaire
To measure quality of life between Schroth SSE with underarm brace and underarm brace alone by SRS-7 questionaire
Measured: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Measure health outcomes between Schroth SSE with underarm brace and underarm brace alone by EQ-5D-5L
To measure health outcomes between Schroth SSE with underarm brace and underarm brace alone by EQ-5D-5L
Measured: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Measure patients' perception of their appearance between Schroth SSE with underarm brace and underarm brace alone by Trunk Appearance Perception Scale (TAPS)
To measure patients' perception of their appearance between Schroth SSE with underarm brace and underarm brace alone by Trunk Appearance Perception Scale (TAPS)
Measured: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Measure levels of pain between Schroth SSE with underarm brace and underarm brace alone by Numeric Pain Ratings
To measure levels of pain between Schroth SSE with underarm brace and underarm brace alone by Numeric Pain Ratings
Measured: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Oct 2017
- Study start18 Dec 2017
- Primary completion30 Jun 2023 (estimated)
- Study completion30 Jun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Adolescent Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by The 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
- Model description
- Patients diagnosed with AIS referred for bracing through the hospital's specialist outpatient clinic are eligible to enrol the study. The Investigator will document whether each patient meets the selection criteria before enrolment into the study. The Investigator or designee will also obtain an IRB/EC approved Informed consent from each patient and/or guardian. Recruited patients will be randomly assigned to either SSE group or control group in a ratio of 1:1. The radiographic evaluation, physical examination and PROM questionnaires will be assessed at baseline, post-treatment 3 months, 6 months, 12 months and until skeletal maturity.
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 98 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Responsible party
- Principal investigator, Dr. Kenny Kwan, The University of Hong Kong
- Investigators
- Dr Kenny Kwan, BMBCh(Oxon), Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03305185
- Sponsor's protocol ID
- UW 16-206
- Status last verified
- Feb 2023
- First submitted
- 20 Sep 2017
- Last updated
- 6 Feb 2023
- 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 6 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Scoliosis Specific Exercise (SSE) in Patients With Adolescent Idiopathic Scoliosis (AIS) During Bracing: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT03305185
- Acronym / sponsor ID
- UW 16-206
- Conditions
- Adolescent Idiopathic Scoliosis
- Keywords
- AIS
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Hong Kong Polytechnic University
- Study start
- 18 Dec 2017 (actual)
- Primary completion
- 30 Jun 2023 (estimated)
- Study completion
- 30 Jun 2023 (estimated)
- First posted
- 9 Oct 2017 (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.
The purpose of this study is to examine the effectiveness of Schroth scoliosis-specific exercises (SSE) on patients with adolescent idiopathic scoliosis (AIS) during bracing. The goal is to determine if Schroth SSE combined with bracing can is superior in controlling curve progression when compared with bracing alone. Curve progression is defined as worsening of coronal Cobb angle of 6 degrees or more.
Detailed description
Adolescent Idiopathic scoliosis (AIS) is a three-dimensional deformity of the spine, characterized by a lateral curvature and vertebral rotation. Its prevalence is estimated to be 2.5% in children between aged 10 and 16 in Hong Kong. Curve progression occurs during pubertal growth spurt. If the primary curve does not exceed 40 degree at skeletal maturity, it is unlikely to continue to progress, and there are little or no long-term clinical consequences. However, if the curve progresses beyond 50 degree during adolescence, it may cause functional limitation, accelerated disc degeneration with potential neurological deficit, cosmetic concerns, decreased quality of life, and possible progression in adulthood. Thus, surgical correction of the deformity with instrumented spinal fusion is usually recommended if the curve reaches 50 degree during adolescence.
Currently, spinal bracing is the only the only non-operative treatment supported with high-quality evidence that can prevent curve progression. In a randomized controlled trial, Weinstein et al. recently reported in the New England Journal of Medicine that bracing was effective in preventing curve progression to threshold for surgery in 72% of cases. The trial was terminated early due to the treatment benefit in favor of bracing. Nonetheless, the authors reported a treatment failure rate of 25% in the randomized cohort, which was similar to previous published studies. Hence, despite the best available non-operative treatment, the number of adolescents ultimately requiring surgery remains substantial. Surgery is associated with medical comorbidities, can cause psychosocial stress to the children and their families, and has significant financial impact on healthcare, with the total costs of spinal surgery to correct AIS ranked second only to appendicitis among children 10 to 17 years of age. Consequently, further effective strategies to prevent scoliosis progression in children are needed.
Scoliosis-specific exercise (SSE) has been proposed as an additional non-operative intervention that may reduce curve progression during the adolescent growth spurt. However, the standard of care for non-operative treatment of AIS varies widely between North America and Europe, and the use of SSE is not universally accepted. SSE is a potentially low-cost intervention that will be of substantial benefit even if a relative risk reduction in curve progression or reaching the threshold for surgery is reduced in a modest proportion of those participating.
SSE, as opposed to generalized physiotherapy, consists of individually-adapted exercises that aim to promote spinal realignment through self-correction and stabilization, as well as modulating patterns of trunk muscles recruitment. Electromyography (EMG) of paraspinal and abdominal muscles in AIS patients revealed disrupted patterns of muscles recruitment, which are associated with a disparity in trunk isometric rotation strength between sides. AIS patients demonstrate proprioceptive and balance control problems, along with a distorted body schema, resulting in a mismatch between the actual spinal alignment and the patients' internal representation of the body. SSE aims to reverse the anomalous patterns of muscle recruitment through training, and modify the body schema with visual and somatosensory feedback. This forms the theoretical neurophysiological basis for using this treatment strategy for AIS.
Schroth SSE is one of the most studied and widely-used schools of SSE. It is a technique tailored to the type of scoliosis and the curve magnitude of each patient. It is based on vertebrae deflections and sagittal corrections that result in horizontal vertebrae de-rotation. It uses rotational breathing and postural auto-correction to reverse the underlying impairments in spinal muscle function, postural control and proprioception which contribute to the development of curvature in AIS. Patients will also be given cognitive behavioral strategies to empower them to self-manage their conditions.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Patients diagnosed with AIS referred for bracing through the hospital's specialist outpatient clinic are eligible to enrol the study. The Investigator will document whether each patient meets the selection criteria before enrolment into the study. The Investigator or designee will also obtain an IRB/EC approved Informed consent from each patient and/or guardian. Recruited patients will be randomly assigned to either SSE group or control group in a ratio of 1:1. The radiographic evaluation, physical examination and PROM questionnaires will be assessed at baseline, post-treatment 3 months, 6 months, 12 months and until skeletal maturity.
| Arm | Type | Receives |
|---|---|---|
| Schroth SSE with Bracing | Experimental | Combination Product: Schroth SSE with BracingPatients in this group will be prescribed an outpatient-based Schroth exercise program, as per our preliminary study. It consists of an individualised eight-week outpatient program that includes four initial private training sessions, once every two weeks, where exercises will be taught to the patient and their caregivers. A home exercise program will be instituted thereafter and patients will be required to return for supervised sessions once every two months. |
| Bracing alone | Active comparator | Device: Bracing alonePatients in the control group will receive standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will only attend study assessments with no extra physiotherapy sessions. |
Who may qualify
- Ages
- 10 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosis of AIS
- Male or female from 10 to 15 year-old, inclusive, at the time of consent provided
- Skeletal immaturity, defined as a Risser grade (amount of ossification and eventual fusion of the iliac apophysis) of 0, 1, or 2
- Cobb angle of 25-40
- No prior conservative or surgical treatment for AIS
Key exclusion criteria (6 listed)
- An underlying cause or association that may cause scoliosis
- Leg length discrepancies or lower limb deformities that may interfere with spinal posture
- Previous spinal surgery
- Cognitive impairment
- Those receiving any other forms of treatment including alternative medicine for the treatment of their scoliosis
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 |
|---|---|---|
| Schroth SSE with BracingPatients in this group will be prescribed an outpatient-based Schroth exercise program, as per our preliminary study. It consists of an individualised eight-week outpatient program that includes four initial private training sessions, once every two weeks, where exercises will be taught to the patient and their caregivers. A home exercise program will be instituted thereafter and patients will be required to return for supervised sessions once every two months. | Combination product | Schroth SSE with Bracing |
| Bracing alonePatients in the control group will receive standard level of care for bracing, which consists of education on general exercises for spinal movement, strengthening, and balancing. These patients will only attend study assessments with no extra physiotherapy sessions. | Device | Bracing alone |
Primary outcome
Effect of Schroth SSE during bracing versus bracing alone in AIS patients as determined by the difference in coronal Cobb angle pre- and one year post-treatment
Time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
1. To evaluate the effect of Schroth SSE during bracing versus bracing alone in AIS patients as determined by the difference in coronal Cobb angle pre- and one year post-treatment
9 secondary outcomes
Compare changes in sagittal plane radiological parameter between Schroth SSE with bracing and bracing alone by EOS Imaging System
Time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Compare changes in transverse plane radiological parameter between Schroth SSE with bracing and bracing alone by EOS Imaging System
Time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Compare changes in surface topography between Schroth SSE with bracing and bracing alone using Bunnell's scoliometer
Time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Compare changes in surface topography between Schroth SSE with bracing and bracing alone using clinical photography
Time frame: baseline, 6 months, 12 months, until skeletal maturity
Compare changes in surface topography between Schroth SSE with bracing and bracing alone using VITUS Smart XXL 3D body scanner system
Time frame: baseline, 6 months, 12 months, until skeletal maturity
Measure quality of life between Schroth SSE with underarm brace and underarm brace alone by SRS-7 questionaire
Time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Measure health outcomes between Schroth SSE with underarm brace and underarm brace alone by EQ-5D-5L
Time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Measure patients' perception of their appearance between Schroth SSE with underarm brace and underarm brace alone by Trunk Appearance Perception Scale (TAPS)
Time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Measure levels of pain between Schroth SSE with underarm brace and underarm brace alone by Numeric Pain Ratings
Time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Feb 2023.
- 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.
Dr Kenny Kwan, BMBCh(Oxon) principal investigator
The University of Hong Kong
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Schroth SSE with Bracing and Bracing alone in people with Adolescent Idiopathic Scoliosis, run by The University of Hong Kong at 1 site in 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 6 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 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. 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?
Results are not available in the source record.
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?
Effect of Schroth SSE during bracing versus bracing alone in AIS patients as determined by the difference in coronal Cobb angle pre- and one year post-treatment (time frame: baseline, 3 months, 6 months, 12 months, until skeletal maturity). 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 6 Feb 2023.