Idiopathic ScoliosisNCT05138393
Scoliosis-specific Exercises for Mild Idiopathic Scoliosis
A study testing Active self-corrective exercises and Observation 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 15 years
- Conditions the study is for
- Idiopathic Scoliosis
- What is being tested?
- Active self-corrective exercises and Observation
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 2 sitesSweden
- Study dates
- 18 Feb 2022to 30 Nov 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 15 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- Cobb 15-24 degrees
- Skeletally immature, Sanders score of 4 or less and Risser < 2.
- No menarche for females
- Aged 9-15 years
- Apex of the primary curve at T7 or caudal
Who cannot join
- Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)
- No previous surgical or brace treatment for scoliosis
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
- 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: PREventing Mild Idiopathic SCOliosis PROgression (PREMISCOPRO): a Randomized Controlled Trial Comparing Scoliosis-specific Exercises to Observation in Mild Idiopathic Scoliosis
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. In Sweden, mild scoliosis curves not requiring treatment, but at risk for progression during childhood, are only observed until skeletal maturity without active treatment. If progression occurs and treatment is required, standard treatment consists of bracing 20 hours or more per day. Scoliosis-specific exercises have been reported to be a possible treatment modality in terms of halting progression in mild scoliosis, but the findings are not generally accepted.
Read the detailed description
Mild forms of idiopathic scoliosis are usually observed with regular clinical and radiological follow-ups during growth periods. Scoliosis specific exercises have been used as a method aiming to halt progression and ultimately avoid the need of brace treatment. However, many cases of mild idiopathic scoliosis will not progress irrespective of treatment. As of today, there are a number of different methods and approaches to scoliosis specific exercises, but all with the aim to correct scoliosis in the sagittal, frontal and transverse plane.
In a multicenter randomized controlled trial, the investigators seek to compare an active self corrective management of scoliosis specific exercises to observation for patients with mild scoliosis. Skeletally immature patients with mild idiopathic scoliosis will be randomized in an online module through the Swedish spine register (www.swespine.se), to receive either the intervention or observation. Outcome assessors will be blinded for the type of management the patients are having. Compliance will be monitored with a mobile application (Physitrack) where the patients and their families can have direct access to the research personnel and their treatment. Outcome measures include changes in curve severity, quality of life, number of patients requiring brace treatment and clinical outcomes. All patients will be evaluated with clinical follow-ups every six months and both clinical and radiological follow-ups each twelve months until either progression occurs or skeletal maturity is reached. Individuals progressing and requiring brace treatment will be offered standard TLSO or nighttime brace to be worn 20 hours and 8 hours, respectively, per day and will be followed in the same way as other participants. Skeletal maturity is defined as less than 1 cm of growth in six months. All patients will be encouraged to be physically active for 60 minutes per day. When skeletal maturity has occured, patients will have clinical and radiological follow-ups at 2, 5 and 10 years after treatment termination. Based on a hypothesized failure rate of 10% in the scoliosis specific exercise group and 39% in the observation group, with a significance level of 5% and a power of 80% and consideration for dropout of up to 20% and an additional adding of five individuals per group, an estimated number of 45 individuals in each group is required.
For individuals who are not willing to be randomized and participate in the study, observation will be offered and these individuals will serve as an observational group with similar follow-ups and will be asked to answer the same survey as the study groups will do.
- Conditions
- Idiopathic Scoliosis
- Being tested
- Active self-corrective exercises, Observation
- Keywords
- Idiopathic scoliosis, Randomized controlled trial, Exercise, Rehabilitation, Self-correction
- Medical subject headings
- Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Active self-corrective exercisesOther
Scoliosis specific exercises with an Active self-corrective approach. Non-specific physical activity 60 minutes per day.
ObservationOther
Non-specific physical activity 60 minutes per day.
| Study group | Role | What they receive |
|---|---|---|
| Active self-corrective exercises | Experimental | An active self-correction tailored to the individual type of curve and clinical presentation will be applied with the aim to correct the scoliosis in all three planes. Patients will also be informed and educated in task oriented activities of daily living. Training goals are directed towards postural control, spinal stability, muscular stabilization and endurance in corrective postures. Patients will have outpatient sessions once every two weeks the first 3 months and perform the exercises at home in 30-minutes sessions three times per week. Patients are encouraged to continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily. Compliance will be monitored through a mobile application (Physitrack) where the patients record their sessions and can have contact with the research personnel. A cognitive behavioral therapy approach to reinforce physical activity will be performed every 6 months. Receives: Other: Active self-corrective exercises |
| Observation | Active comparator | Patients are encouraged to continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. A cognitive behavioral therapy approach to reinforce physical activity will be performed every 6 months. Receives: Other: Observation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients progressing in curve severity
Increase in curve severity (Cobb angle) of more than 6 degrees on two consecutive full-spine frontal radiographs as compared with baseline
Measured: Measured at each radiological (annual) follow-up until skeletal maturity. Skeletal maturity is defined as less than 1 cm body height increase in 6 months
Secondary outcomes (6)
Angle of trunk rotation
Angle of trunk rotation in forward bending, assessed according to Adams forward bending test with Bunnell's scoliometer
Measured: At each six-month follow-up and at 2, 5, 10 years after skeletal maturity
Patient-reported outcome measures
Scoliosis Research Society-22r questionnaire (SRS-22r) ranging from 1 (worst) to 5 (best)
Measured: At each six-months follow-up and 2, 5, 10 years after skeletal maturity
Patient-reported outcome measures
The child-friendly EQ-5D version (EQ-5D-Y) with values ranging from 1 (best) to 3 (worst)
Measured: At each six-month follow-up and 2, 5, 10 years after skeletal maturity
Patient-reported outcome measures
Pictorial part of Spinal Appearance Questionnaire (pSAQ) with values ranging from 7 (best) to 35 (worst)
Measured: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Patient-reported outcome measures
International Physical Activity Questionnaire-short form (IPAQ-SF) where data will be presented as energy expenditure, Metabolic Equivalent Task (MET) minutes, and proportion of individuals reaching moderate activity level. Moderate activity level is considered if 3 or more days of vigorous activity of at least 20 minutes per day, 5 or more days of moderate-intensity activity and/or walking of at least 30 minutes per day, or 5 or more days of any combination of walking, moderate-intensity, or vigorous-intensity activities accumulating at least 600 MET-minutes per week
Measured: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
Brace treatment
Number of patients needing brace treatment. Indication for brace treatment is progression of more than 6 degrees on standing frontal radiograph and a primary curve surpassing 25 degrees.
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 posted1 Dec 2021
- Study start18 Feb 2022
- Primary completion30 Nov 2027 (estimated)
- Study completion30 Nov 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- 90 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
- NCT05138393
- Sponsor's protocol ID
- ED-PG-AA-2021-SSE
- Status last verified
- Aug 2026
- First submitted
- 5 Nov 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.
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
- PREventing Mild Idiopathic SCOliosis PROgression (PREMISCOPRO): a Randomized Controlled Trial Comparing Scoliosis-specific Exercises to Observation in Mild Idiopathic Scoliosis
- ClinicalTrials.gov ID
- NCT05138393
- Acronym / sponsor ID
- ED-PG-AA-2021-SSE
- Conditions
- Idiopathic Scoliosis
- Keywords
- Idiopathic scoliosis, Randomized controlled trial, Exercise, Rehabilitation, Self-correction
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Karolinska InstitutetUniversity, hospital or other
- Collaborators
- Linkoeping University
- Study start
- 18 Feb 2022 (actual)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- 30 Nov 2037 (estimated)
- First posted
- 1 Dec 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. In Sweden, mild scoliosis curves not requiring treatment, but at risk for progression during childhood, are only observed until skeletal maturity without active treatment. If progression occurs and treatment is required, standard treatment consists of bracing 20 hours or more per day. Scoliosis-specific exercises have been reported to be a possible treatment modality in terms of halting progression in mild scoliosis, but the findings are not generally accepted.
Detailed description
Mild forms of idiopathic scoliosis are usually observed with regular clinical and radiological follow-ups during growth periods. Scoliosis specific exercises have been used as a method aiming to halt progression and ultimately avoid the need of brace treatment. However, many cases of mild idiopathic scoliosis will not progress irrespective of treatment. As of today, there are a number of different methods and approaches to scoliosis specific exercises, but all with the aim to correct scoliosis in the sagittal, frontal and transverse plane.
In a multicenter randomized controlled trial, the investigators seek to compare an active self corrective management of scoliosis specific exercises to observation for patients with mild scoliosis. Skeletally immature patients with mild idiopathic scoliosis will be randomized in an online module through the Swedish spine register (www.swespine.se), to receive either the intervention or observation. Outcome assessors will be blinded for the type of management the patients are having. Compliance will be monitored with a mobile application (Physitrack) where the patients and their families can have direct access to the research personnel and their treatment. Outcome measures include changes in curve severity, quality of life, number of patients requiring brace treatment and clinical outcomes. All patients will be evaluated with clinical follow-ups every six months and both clinical and radiological follow-ups each twelve months until either progression occurs or skeletal maturity is reached. Individuals progressing and requiring brace treatment will be offered standard TLSO or nighttime brace to be worn 20 hours and 8 hours, respectively, per day and will be followed in the same way as other participants. Skeletal maturity is defined as less than 1 cm of growth in six months. All patients will be encouraged to be physically active for 60 minutes per day. When skeletal maturity has occured, patients will have clinical and radiological follow-ups at 2, 5 and 10 years after treatment termination. Based on a hypothesized failure rate of 10% in the scoliosis specific exercise group and 39% in the observation group, with a significance level of 5% and a power of 80% and consideration for dropout of up to 20% and an additional adding of five individuals per group, an estimated number of 45 individuals in each group is required.
For individuals who are not willing to be randomized and participate in the study, observation will be offered and these individuals will serve as an observational group with similar follow-ups and will be asked to answer the same survey as the study groups will do.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Active self-corrective exercises | Experimental | Other: Active self-corrective exercisesAn active self-correction tailored to the individual type of curve and clinical presentation will be applied with the aim to correct the scoliosis in all three planes. Patients will also be informed and educated in task oriented activities of daily living. Training goals are directed towards postural control, spinal stability, muscular stabilization and endurance in corrective postures. Patients will have outpatient sessions once every two weeks the first 3 months and perform the exercises at home in 30-minutes sessions three times per week. Patients are encouraged to continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily. Compliance will be monitored through a mobile application (Physitrack) where the patients record their sessions and can have contact with the research personnel. A cognitive behavioral therapy approach to reinforce physical activity will be performed every 6 months. |
| Observation | Active comparator | Other: ObservationPatients are encouraged to continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. A cognitive behavioral therapy approach to reinforce physical activity will be performed every 6 months. |
Who may qualify
- Ages
- 9 to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Cobb 15-24 degrees
- Skeletally immature, Sanders score of 4 or less and Risser < 2.
- No menarche for females
- Aged 9-15 years
- Apex of the primary curve at T7 or caudal
Key exclusion criteria (2 listed)
- Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)
- No previous surgical or brace 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 |
|---|---|---|
| Active self-corrective exercisesScoliosis specific exercises with an Active self-corrective approach. Non-specific physical activity 60 minutes per day. | Other | Active self-corrective exercises |
| ObservationNon-specific physical activity 60 minutes per day. | Other | Observation |
Primary outcome
Number of patients progressing in curve severity
Time frame: Measured at each radiological (annual) follow-up until skeletal maturity. Skeletal maturity is 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 full-spine frontal radiographs as compared with baseline
6 secondary outcomes
Angle of trunk rotation
Time frame: At each six-month follow-up and at 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
Brace treatment
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.
- Individual participant dataSharing planned: Yes. IPD underlying published manuscripts will be accessible for other researchers.
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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 Active self-corrective exercises and Observation 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 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: 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@regionstockholm.se), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients progressing in curve severity (time frame: Measured at each radiological (annual) follow-up until skeletal maturity. Skeletal maturity is 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?
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.