Idiopathic ScoliosisPRISCOPRONCT04805437
Brace Treatment for Idiopathic Scoliosis; PReventing Idiopathic SCOliosis PROgression
A study testing 3D TLSO and Standard TLSO in people with Idiopathic Scoliosis, run by Karolinska Institutet at 2 sites in Sweden.
Trial summary
Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. 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?
- 3D TLSO and Standard TLSO
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 2 sitesSweden
- Study dates
- 30 Apr 2021to Apr 2037
- 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
- Cobb 25-40 degrees
- Skeletally immature, Sanders score of 6 or less and Risser 2 or less.
- Menarche status maximum one year in females
- Aged 9-17 years
- No previous brace treatment or surgery for scoliosis
- Apex of the primary curve at T7 or caudal
Who cannot join
- Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)
- Previous spine surgery
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Paul Gerdhem, MD, PhD contact
Sweden2 sites, 2 recruiting
- Not yet recruiting
Linköping university hospital
Linköping
Allan Abbott, PT, PhD
- Recruiting
Karolinska university hospital
Stockholm
Elias Diarbakerli, PT, PhD
Paul Gerdhem, MD, PhD
About this study
Official title: 3D Designed Boston Brace Versus Standard Boston Brace in Halting Progression in Idiopathic Scoliosis: a Randomized Controlled Trial
Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. When brace treatment for scoliosis is indicated, standard treatment consists of bracing 20 hours or more per day. Outcomes of brace treatment depend to a large extent on wearing time and since many adolescents feel uncomfortable in the brace, it is of importance to combine efficacy and comfortability of the brace.
Read the detailed description
Bracing with a rigid TLSO is gold-standard treatment in terms of halting progression of idiopathic scoliosis in skeletally immature adolescents and children. The treatment is cumbersome and demanding for adolescents during a vulnerable stage in life, and may be associated with poor compliance. Furthermore, the treatment lasts in many cases for several years and has shown to have a negative psychological effect for patients. Since time in brace is of utmost importance for best possible outcome, the braces need to be tolerated by the patients. As of today, 3D designed braces have received much attention and are thought to increase comfortability and ultimately increase wearing time, leading to better outcomes.
In a multicenter randomized controlled trial, we seek to compare standard Boston brace to a newly developed 3D designed Boston brace. Skeletally immature patients with idiopathic scoliosis will be randomized to receive either standard Boston brace or Boston 3D brace. All patients will be encouraged to be physically active for 60 minutes per day. Patients, outcome assessors and clinician in charge during follow-ups will be blinded for the type of brace the patients are being treated with. Thermal sensors will be installed in all braces to monitor compliance. Outcome include change in curve severity, quality of life and surgical rates. Patients will be evaluated with clinical and radiological follow-ups every six months until skeletal maturity and thereafter at 2, 5 and 10 years. Curve progression will not lead to change of brace. A total of 85 individuals are required in each group based on the hypothesis of a 2% failure rate in the 3D-brace group and 15% in the standard brace group with 5% significance level and 80% power and consideration for dropout of up to 20%.
For individuals who are not willing to be randomized and participate in the study, standard Boston brace will be offered and these individuals will serve as an observational group with similar follow-ups and will be asked to answer same survey as the study populations will do.
- Conditions
- Idiopathic Scoliosis
- Being tested
- 3D TLSO, Standard TLSO
- Keywords
- Idiopathic scoliosis, Randomized controlled trial, Brace, Orthosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3D TLSODevice
Also called Boston 3D brace
Brace treatment with Boston 3D 20 hours a day until skeletal maturity.
Standard TLSODevice
Also called Boston brace
Brace treatment with standard Boston brace 20 hours a day until skeletal maturity.
| Study group | Role | What they receive |
|---|---|---|
| 3D TLSO | Experimental | A 3-dimensional Boston brace will be designed to the patient's individual type of scoliosis. In-brace radiographs will be performed after prescription. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. Patients are encouraged to use the brace for 20 hours per day and to also continue with physical activities for the entirety of the study. Compliance will be monitored with a heat sensor built in the brace that measures wearing time. Receives: Device: 3D TLSO |
| Standard TLSO | Active comparator | A standard Boston brace will be designed to the patient's individual type of scoliosis. In brace radiographs will be performed after prescription. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. Patients are encouraged to use the brace for 20 hours per day and to also continue with physical activities for the entirety of the study. Compliance will be monitored with a heat sensor built in the brace that measures wearing time. Receives: Device: Standard TLSO |
What is being measured
The primary outcome is the main question the study is designed to answer.
Curve progression
Increase in curve severity (Cobb angle) of more than 6 degrees on two consecutive radiographs after baseline
Measured: Measured at each six-month follow-up until skeletal maturity. Skeletal maturity defined as less than 1 cm body height increase in 6 months.
Secondary outcomes (6)
Clinical outcomes
Angle of trunk rotation in forward bending, assessed with scoliometer
Measured: At each six-month follow-up and 2, 5, 10 years after skeletal maturity
Patient-reported outcome measures
Scoliosis Research Society-22r questionnaire
Measured: At each six-months follow-up and 2, 5, 10 years after skeletal maturity
Patient-reported outcome measures
EQ5D questionnaire
Measured: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Patient-reported outcome measures
Spinal Appearance Questionnaire (SAQ)
Measured: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Patient-reported outcome measures
International Physical Activity Questionnaire (IPAQ)
Measured: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Surgical rates
Number needing surgical intervention
Measured: At each six-months follow-up and 2, 5, 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 posted18 Mar 2021
- Study start30 Apr 2021
- Primary completionSep 2027 (estimated)
- Study completionApr 2037 (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 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Karolinska Institutet
- Sponsor type
- University, hospital or other
- Collaborators
- Linkoeping University
- Responsible party
- Principal investigator, Paul Gerdhem, Karolinska Institutet
- Investigators
- Elias Diarbakerli, PT, PhD, Principal investigator, Karolinska Institutet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805437
- Sponsor's protocol ID
- ED-PG-AA-2021-Brace
- Acronym
- PRISCOPRO
- Status last verified
- Aug 2026
- First submitted
- 13 Mar 2021
- Last updated
- 27 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: IPD underlying published manuscripts will be accessible for other researchers.
Publications
Diarbakerli E, Charalampidis A, Abbott A, Gerdhem P. PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace. PLoS One. 2021 Aug 9;16(8):e0255264. doi: 10.1371/journal.pone.0255264. eCollection 2021.
PubMed 34370760
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
- 3D Designed Boston Brace Versus Standard Boston Brace in Halting Progression in Idiopathic Scoliosis: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04805437
- Acronym / sponsor ID
- PRISCOPRO / ED-PG-AA-2021-Brace
- Conditions
- Idiopathic Scoliosis
- Keywords
- Idiopathic scoliosis, Randomized controlled trial, Brace, Orthosis
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 30 Apr 2021 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Apr 2037 (estimated)
- First posted
- 18 Mar 2021 (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.
Idiopathic scoliosis is the most common spinal deformity in children and adolescents with an estimated prevalence of 3%. About one tenth of the children with scoliosis develop a deformity that requires treatment with brace or surgery with the current treatment protocol. When brace treatment for scoliosis is indicated, standard treatment consists of bracing 20 hours or more per day. Outcomes of brace treatment depend to a large extent on wearing time and since many adolescents feel uncomfortable in the brace, it is of importance to combine efficacy and comfortability of the brace.
Detailed description
Bracing with a rigid TLSO is gold-standard treatment in terms of halting progression of idiopathic scoliosis in skeletally immature adolescents and children. The treatment is cumbersome and demanding for adolescents during a vulnerable stage in life, and may be associated with poor compliance. Furthermore, the treatment lasts in many cases for several years and has shown to have a negative psychological effect for patients. Since time in brace is of utmost importance for best possible outcome, the braces need to be tolerated by the patients. As of today, 3D designed braces have received much attention and are thought to increase comfortability and ultimately increase wearing time, leading to better outcomes.
In a multicenter randomized controlled trial, we seek to compare standard Boston brace to a newly developed 3D designed Boston brace. Skeletally immature patients with idiopathic scoliosis will be randomized to receive either standard Boston brace or Boston 3D brace. All patients will be encouraged to be physically active for 60 minutes per day. Patients, outcome assessors and clinician in charge during follow-ups will be blinded for the type of brace the patients are being treated with. Thermal sensors will be installed in all braces to monitor compliance. Outcome include change in curve severity, quality of life and surgical rates. Patients will be evaluated with clinical and radiological follow-ups every six months until skeletal maturity and thereafter at 2, 5 and 10 years. Curve progression will not lead to change of brace. A total of 85 individuals are required in each group based on the hypothesis of a 2% failure rate in the 3D-brace group and 15% in the standard brace group with 5% significance level and 80% power and consideration for dropout of up to 20%.
For individuals who are not willing to be randomized and participate in the study, standard Boston brace will be offered and these individuals will serve as an observational group with similar follow-ups and will be asked to answer same survey as the study populations will do.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 3D TLSO | Experimental | Device: 3D TLSOA 3-dimensional Boston brace will be designed to the patient's individual type of scoliosis. In-brace radiographs will be performed after prescription. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. Patients are encouraged to use the brace for 20 hours per day and to also continue with physical activities for the entirety of the study. Compliance will be monitored with a heat sensor built in the brace that measures wearing time. |
| Standard TLSO | Active comparator | Device: Standard TLSOA standard Boston brace will be designed to the patient's individual type of scoliosis. In brace radiographs will be performed after prescription. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. Patients are encouraged to use the brace for 20 hours per day and to also continue with physical activities for the entirety of the study. Compliance will be monitored with a heat sensor built in the brace that measures wearing time. |
Who may qualify
- Ages
- 9 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Cobb 25-40 degrees
- Skeletally immature, Sanders score of 6 or less and Risser 2 or less.
- Menarche status maximum one year in females
- Aged 9-17 years
- No previous brace treatment or surgery for scoliosis
Key exclusion criteria (2 listed)
- Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)
- Previous spine surgery
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 |
|---|---|---|
| 3D TLSOAlso: Boston 3D braceBrace treatment with Boston 3D 20 hours a day until skeletal maturity. | Device | 3D TLSO |
| Standard TLSOAlso: Boston braceBrace treatment with standard Boston brace 20 hours a day until skeletal maturity. | Device | Standard TLSO |
Primary outcome
Curve progression
Time frame: Measured at each six-month follow-up until skeletal maturity. Skeletal maturity defined as less than 1 cm body height increase in 6 months.
Increase in curve severity (Cobb angle) of more than 6 degrees on two consecutive radiographs after baseline
6 secondary outcomes
Clinical outcomes
Time frame: At each six-month follow-up and 2, 5, 10 years after skeletal maturity
Patient-reported outcome measures
Time frame: At each six-months follow-up and 2, 5, 10 years after skeletal maturity
Patient-reported outcome measures
Time frame: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Patient-reported outcome measures
Time frame: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Patient-reported outcome measures
Time frame: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Surgical rates
Time frame: At each six-months follow-up and 2, 5, 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 34370760Diarbakerli E, Charalampidis A, Abbott A, Gerdhem P. PReventing Idiopathic SCOliosis PROgression (PRISCOPRO): A protocol for a quadruple-blinded, randomized controlled trial comparing 3D designed Boston brace to standard Boston brace. PLoS One. 2021 Aug 9;16(8):e0255264. doi: 10.1371/journal.pone.0255264. eCollection 2021.
- Individual participant dataSharing planned: Yes. IPD underlying published manuscripts will be accessible for other researchers.
Related trials for Idiopathic Scoliosis
Active, not recruiting
Diaphragm Mobilization in Adolescent Idiopathic Scoliosis
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Tranexamic Acid in Pediatric Idiopathic Scoliosis Surgery
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Turkish Adaptation and Validation of the Scoliosis Misconception Scale in Adolescents With Idiopathic Scoliosis
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Clinical and Biological Parameters in Adolescent Idiopathic Scoliosis
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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.
Paul Gerdhem, MD, PhD contact
Elias Diarbakerli, PT, PhD principal investigator
Karolinska Institutet
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3D TLSO and Standard TLSO in people with Idiopathic Scoliosis, run by Karolinska Institutet at 2 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 6 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: looking for participants now, 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 2 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?
Contact Elias Diarbakerli, PT, PhD (+460851770000, elias.diarbakerli@sll.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Curve progression (time frame: Measured at each six-month follow-up until skeletal maturity. Skeletal maturity defined as less than 1 cm body height increase in 6 months.). 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 NCT04805437, 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 27 Aug 2026.