Idiopathic ScoliosisCONTRAISNCT01761305
Trial on Three Treatments for Scoliosis
A study testing Hypercorrective night-time brace, Scoliosis specific exercises. and Self-mediated physical activity. in people with Idiopathic Scoliosis, run by Karolinska Institutet at 7 sites in Sweden.
Trial summary
Idiopathic scoliosis is a three-dimensional structural deformity of the spine that occurs in children. Recent reviews on bracing and exercise treatment have provided some evidence for effect of these interventions. Read more about this study
- Who is it for?
- Ages 9 to 17 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Hypercorrective night-time brace, Scoliosis specific exercises. and Self-mediated physical activity.
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 135 participants
- Where
- 7 sitesSweden
- Study dates
- Jan 2013to Dec 2030
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 9 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Diagnosis of idiopathic scoliosis
- Skeletally immature with estimated remaining growth for at least one year.
- Not more than one year after menarche
- Primary Cobb angle between 25 and 40 degrees.
- Curve apex T7 or caudal
Who cannot join
- Scoliosis with a possible non-idiopathic ethiology. Patients will be excluded from the study if the pathogenesis of the scoliosis is not idiopathic, but due to a neuromuscular, neurological, congenital malformation or trauma related comorbidity.
- Previous brace or surgical treatment for scoliosis.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Sweden7 sites
Mälarsjukhuset / Eskilstuna hospital
Eskilstuna, 63188
Ryhov Hospital
Jönköping, 55185
Linköping University, Linköping University Hospital
Linköping, 58183
Karolinska University Hospital
Stockholm, 14186
Sundsvall Hospital
Sundsvall, 85186
Umeå University, Norrland University Hospital
Umeå, 90185
Västerås Hospital
Västerås, 72189
About this study
Official title: CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis. A Randomised Controlled Trial
Idiopathic scoliosis is a three-dimensional structural deformity of the spine that occurs in children. Recent reviews on bracing and exercise treatment have provided some evidence for effect of these interventions. The purpose of this study is to compare the effectiveness of night time bracing, scoliosis specific exercises and physical activity prescription in adolescents with idiopathic scoliosis.
Read the detailed description
Today, bracing is used to prevent progression of idiopathic scoliosis in children.
The evidence for bracing and physical activity for treatment of idiopathic scoliosis is poor. Only one low quality study has compared bracing with physical exercise, showing no statistical differences in the reduction or progression of scoliosis curves between the groups. To draw valid conclusions about the effectiveness of postural specific physical exercise and brace therapeutic interventions compared to a self mediated activity exercise group, a randomized controlled trial research design will be used.
Preliminary data suggests that approximately 8 hours of night-time bracing with an over-corrective brace is as effective as bracing during 23 hours per day. Night-time bracing is attractive since you wear the brace a limited amount of time.
Several theories propose that during the adolescent period of skeletal growth, bone deformation may occur due to a combination of asymetrical growth plate activity, vertebral body weakness or an imbalance of muscle forces and joint flexibility. An association between low bone mineral density and idiopathic scoliosis has been reported in the literature. Adequate physical activity levels is a requirement for normal growth and development during childhood and adolescents. It is well documented that physical exercise is associated with improvements in not only muscle strength, aerobic fitness and motor development but also bone density which may help decrease the risk of osteopenic related bone deformation.
Patients included in the study will be randomized to one of three groups. Each of the three groups will receive a physical activity prescription according to World Health Organisation recommendations. One group will additionally wear a hyper-corrective night-time brace. One group will additionally perform postural scoliosis-specific exercises. Patients not wanting to be randomized to the alternative treatments in the clinical trial will receive bracing which is the current standard treatment offered.
The purpose of the study is to compare the risk of curve progression in the different groups. Curve progression is measured on x-rays. Participation in the study will last until the curve has progressed, or until cessation of skeletal growth. Participants with braces will be instructed to wear the brace 8 hours per night. Participants receiving scoliosis specific training will receive 3x90 minute physiotherapist guided sessions with an additional session provided every 6 months for the entirety of the study. All participants will be recommended to be physically active at least 60 minutes per day.
- Conditions
- Idiopathic Scoliosis
- Being tested
- Hypercorrective night-time brace, Scoliosis specific exercises., Self-mediated physical activity.
- Keywords
- Idiopathic scoliosis, Brace, Scoliosis specific exercise, Physical activity
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypercorrective night-time braceProcedure or surgery
Hypercorrective night-time brace worn 8 hours per night. Patients are encouraged to also continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour.
Scoliosis specific exercises.Behavioural
The intervention will be delivered in 3 x 90 minute sessions, once per month during the first 3 months. Goals are directed towards active self-correction and postural control, spinal stability, aerobic functioning and development of a positive body image. Additional postural specific exercises including self-mediated hyper-corrective exercises are to be performed with moderate intensity at least for 30 minutes at least 2-3 times per week. Other physical activities to fulfill the general recommended quota of more than 60 minutes moderate intensity physical activity per day are recommended. Reinforcement of the intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour.
Self-mediated physical activity.Other
Instructions for self-mediated physical activity will be delivered during a 1 hour session. Patients are encouraged to perform self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour.
| Study group | Role | What they receive |
|---|---|---|
| Brace | Experimental | Hypercorrective night-time brace worn 8 hours per night. A prescription of general physical activity will be provided at a dose of 60 minutes per day. Instructions regarding physical activity will be delivered during a one hour session. Receives: Procedure: Hypercorrective night-time brace |
| Scoliosis specific exercises. | Experimental | Scoliosis specific exercises. The intervention will be delivered in 3 x 90 minute sessions, once per month during the first 3 months. An additional session will be provided every 6 months for the entirety of the study. A prescription of general physical activity will be provided at a dose of 60 minutes per day. Receives: Behavioral: Scoliosis specific exercises. |
| Self-mediated physical activity. | Active comparator | A prescription of general physical activity will be provided at a dose of 60 minutes per day. Instructions will be delivered during a 1 hour session. Receives: Other: Self-mediated physical activity. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Radiological progression of scoliosis
Progression of the Cobb angle more than 6 degrees, compared to the primary x-ray, seen on two consecutive spinal standing x-rays.
Measured: Measured every 6 months, for an expected average of three years
Secondary outcomes (5)
Quality of life assessed with questionnaire instruments
Quality of life measured with validated questionnaires such as Euroqol (EQ5D-Y), Scoliosis Research Society outcomes questionnaire 22r (SRS22r), International Physical Activity Questionnaire (IPAQ) and the Walter Reed Visual Assessment Scale.
Measured: Measured every 6 months, for an expected average of three years
Curve severity at end of study.
Curve severity measured as Cobb angle at end of study.
Measured: Measured at end of study, expected at an average of three years after study inclusion
Health economic evaluations; actual cost for a treatment
Actual analysis of direct costs, and estimations of indirect costs.
Measured: Measured at end of study, expected an average of three years after study inclusion
Neuroaxial abnormalities and risk of curve progression
Analysis of prevalence of neuroaxial abnormalities and any risk of scoliosis curve progression
Measured: Analysed when magnetic resonance images are available and all participants has arrived to the primary endpoint of the study
Curve severity comparing night time brace and full time brace
Curve severity measured as Cobb angle after randomization to night time brace, or after refraining randomization and receiving a full time brace
Measured: From brace initiation until skeletal maturity (estimated to about 3 years after inclusion), and 2, 5 and 10 years after skeletal maturity
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startJan 2013
- Primary completion29 Aug 2021
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Idiopathic ScoliosisStudies of the same condition, open and under way.
- More trials run by Karolinska InstitutetThe 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
- 135 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Karolinska University Hospital, Region Stockholm, The Swedish Research Council, University Hospital, Linkoeping
- Responsible party
- Principal investigator, Paul Gerdhem, Karolinska Institutet
- Investigators
- Paul Gerdhem, MD, PhD, Principal investigator, Karolinska Institutet, Karolinska University HospitalAllan Abbott, MPhyt, PhD, Study director, Linköping University- Sweden, Linköping and Karolinska University Hospital - Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761305
- Sponsor's protocol ID
- PG-AA-2012-12-19
- Acronym
- CONTRAIS
- Status last verified
- Aug 2026
- First submitted
- 28 Dec 2012
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Yes: De-identified manuscript data.
Publications
Charalampidis A, Diarbakerli E, Dufvenberg M, Jalalpour K, Ohlin A, Ahl AA, Moller H, Abbott A, Gerdhem P; CONTRAIS Study Group. Nighttime Bracing or Exercise in Moderate-Grade Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352492. doi: 10.1001/jamanetworkopen.2023.52492.
PubMed 38285447Abbott A, Moller H, Gerdhem P. CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2013 Sep 5;14:261. doi: 10.1186/1471-2474-14-261.
PubMed 24007599
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis. A Randomised Controlled Trial
- ClinicalTrials.gov ID
- NCT01761305
- Acronym / sponsor ID
- CONTRAIS / PG-AA-2012-12-19
- Conditions
- Idiopathic Scoliosis
- Keywords
- Idiopathic scoliosis, Brace, Scoliosis specific exercise, Physical activity
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 135 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Karolinska University Hospital, Region Stockholm, The Swedish Research Council, University Hospital, Linkoeping
- Study start
- Jan 2013
- Primary completion
- 29 Aug 2021 (actual)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Jan 2013 (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.
Idiopathic scoliosis is a three-dimensional structural deformity of the spine that occurs in children. Recent reviews on bracing and exercise treatment have provided some evidence for effect of these interventions. The purpose of this study is to compare the effectiveness of night time bracing, scoliosis specific exercises and physical activity prescription in adolescents with idiopathic scoliosis.
Detailed description
Today, bracing is used to prevent progression of idiopathic scoliosis in children.
The evidence for bracing and physical activity for treatment of idiopathic scoliosis is poor. Only one low quality study has compared bracing with physical exercise, showing no statistical differences in the reduction or progression of scoliosis curves between the groups. To draw valid conclusions about the effectiveness of postural specific physical exercise and brace therapeutic interventions compared to a self mediated activity exercise group, a randomized controlled trial research design will be used.
Preliminary data suggests that approximately 8 hours of night-time bracing with an over-corrective brace is as effective as bracing during 23 hours per day. Night-time bracing is attractive since you wear the brace a limited amount of time.
Several theories propose that during the adolescent period of skeletal growth, bone deformation may occur due to a combination of asymetrical growth plate activity, vertebral body weakness or an imbalance of muscle forces and joint flexibility. An association between low bone mineral density and idiopathic scoliosis has been reported in the literature. Adequate physical activity levels is a requirement for normal growth and development during childhood and adolescents. It is well documented that physical exercise is associated with improvements in not only muscle strength, aerobic fitness and motor development but also bone density which may help decrease the risk of osteopenic related bone deformation.
Patients included in the study will be randomized to one of three groups. Each of the three groups will receive a physical activity prescription according to World Health Organisation recommendations. One group will additionally wear a hyper-corrective night-time brace. One group will additionally perform postural scoliosis-specific exercises. Patients not wanting to be randomized to the alternative treatments in the clinical trial will receive bracing which is the current standard treatment offered.
The purpose of the study is to compare the risk of curve progression in the different groups. Curve progression is measured on x-rays. Participation in the study will last until the curve has progressed, or until cessation of skeletal growth. Participants with braces will be instructed to wear the brace 8 hours per night. Participants receiving scoliosis specific training will receive 3x90 minute physiotherapist guided sessions with an additional session provided every 6 months for the entirety of the study. All participants will be recommended to be physically active at least 60 minutes per day.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Brace | Experimental | Procedure: Hypercorrective night-time braceHypercorrective night-time brace worn 8 hours per night. A prescription of general physical activity will be provided at a dose of 60 minutes per day. Instructions regarding physical activity will be delivered during a one hour session. |
| Scoliosis specific exercises. | Experimental | Behavioral: Scoliosis specific exercises.Scoliosis specific exercises. The intervention will be delivered in 3 x 90 minute sessions, once per month during the first 3 months. An additional session will be provided every 6 months for the entirety of the study. A prescription of general physical activity will be provided at a dose of 60 minutes per day. |
| Self-mediated physical activity. | Active comparator | Other: Self-mediated physical activity.A prescription of general physical activity will be provided at a dose of 60 minutes per day. Instructions will be delivered during a 1 hour session. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Diagnosis of idiopathic scoliosis
- Skeletally immature with estimated remaining growth for at least one year.
- Not more than one year after menarche
- Primary Cobb angle between 25 and 40 degrees.
- Curve apex T7 or caudal
Key exclusion criteria (2 listed)
- Scoliosis with a possible non-idiopathic ethiology. Patients will be excluded from the study if the pathogenesis of the scoliosis is not idiopathic, but due to a neuromuscular, neurological, congenital malformation or trauma related comorbidity.
- Previous brace or surgical treatment for 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 |
|---|---|---|
| Hypercorrective night-time braceHypercorrective night-time brace worn 8 hours per night. Patients are encouraged to also continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour. | Procedure or surgery | Brace |
| Scoliosis specific exercises.The intervention will be delivered in 3 x 90 minute sessions, once per month during the first 3 months. Goals are directed towards active self-correction and postural control, spinal stability, aerobic functioning and development of a positive body image. Additional postural specific exercises including self-mediated hyper-corrective exercises are to be performed with moderate intensity at least for 30 minutes at least 2-3 times per week. Other physical activities to fulfill the general recommended quota of more than 60 minutes moderate intensity physical activity per day are recommended. Reinforcement of the intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour. | Behavioural | Scoliosis specific exercises. |
| Self-mediated physical activity.Instructions for self-mediated physical activity will be delivered during a 1 hour session. Patients are encouraged to perform self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour. | Other | Self-mediated physical activity. |
Primary outcome
Radiological progression of scoliosis
Time frame: Measured every 6 months, for an expected average of three years
Progression of the Cobb angle more than 6 degrees, compared to the primary x-ray, seen on two consecutive spinal standing x-rays.
5 secondary outcomes
Quality of life assessed with questionnaire instruments
Time frame: Measured every 6 months, for an expected average of three years
Curve severity at end of study.
Time frame: Measured at end of study, expected at an average of three years after study inclusion
Health economic evaluations; actual cost for a treatment
Time frame: Measured at end of study, expected an average of three years after study inclusion
Neuroaxial abnormalities and risk of curve progression
Time frame: Analysed when magnetic resonance images are available and all participants has arrived to the primary endpoint of the study
Curve severity comparing night time brace and full time brace
Time frame: From brace initiation until skeletal maturity (estimated to about 3 years after inclusion), and 2, 5 and 10 years after skeletal maturity
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2026.
- Derived from this study: PubMed 38285447Charalampidis A, Diarbakerli E, Dufvenberg M, Jalalpour K, Ohlin A, Ahl AA, Moller H, Abbott A, Gerdhem P; CONTRAIS Study Group. Nighttime Bracing or Exercise in Moderate-Grade Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352492. doi: 10.1001/jamanetworkopen.2023.52492.
- Derived from this study: PubMed 24007599Abbott A, Moller H, Gerdhem P. CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2013 Sep 5;14:261. doi: 10.1186/1471-2474-14-261.
- Individual participant dataSharing planned: Yes. De-identified manuscript data.
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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.
Paul Gerdhem, MD, PhD principal investigator
Karolinska Institutet, Karolinska University Hospital
Allan Abbott, MPhyt, PhD study director
Linköping University- Sweden, Linköping and Karolinska University Hospital - Sweden
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypercorrective night-time brace, Scoliosis specific exercises. and Self-mediated physical activity. in people with Idiopathic Scoliosis, run by Karolinska Institutet at 7 sites in Sweden.
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 2 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: under way, not looking for participants, as of the sponsor's last update on 27 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 7 sites in Sweden. 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?
This study is still under way. Results are not available in the source record yet.
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?
Radiological progression of scoliosis (time frame: Measured every 6 months, for an expected average of three years). 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 NCT01761305, which also lists 2 linked publications.
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 27 Aug 2026.