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Scoliosis-specific Exercises for Mild Idiopathic Scoliosis

PREventing Mild Idiopathic SCOliosis PROgression (PREMISCOPRO): a Randomized Controlled Trial Comparing Scoliosis-specific Exercises to Observation in Mild Idiopathic Scoliosis

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05138393
Enrollment
90
Registered
2021-12-01
Start date
2022-02-18
Completion date
2037-11-30
Last updated
2026-08-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Idiopathic Scoliosis

Keywords

Idiopathic scoliosis, Randomized controlled trial, Exercise, Rehabilitation, Self-correction

Brief 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. 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.

Interventions

OTHERActive self-corrective exercises

Scoliosis specific exercises with an Active self-corrective approach. Non-specific physical activity 60 minutes per day.

OTHERObservation

Non-specific physical activity 60 minutes per day.

Sponsors

Karolinska Institutet
Lead SponsorOTHER
Linkoeping University
CollaboratorOTHER_GOV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 15 Years
Healthy volunteers
No

Inclusion criteria

* 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

Exclusion criteria

* Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis) * No previous surgical or brace treatment for scoliosis

Design outcomes

Primary

MeasureTime frameDescription
Number of patients progressing in curve severityMeasured at each radiological (annual) follow-up until skeletal maturity. Skeletal maturity is defined as less than 1 cm body height increase in 6 monthsIncrease in curve severity (Cobb angle) of more than 6 degrees on two consecutive full-spine frontal radiographs as compared with baseline

Secondary

MeasureTime frameDescription
Angle of trunk rotationAt each six-month follow-up and at 2, 5, 10 years after skeletal maturityAngle of trunk rotation in forward bending, assessed according to Adams forward bending test with Bunnell's scoliometer
Patient-reported outcome measuresAt each six-months follow-up and 2, 5, 10 years after skeletal maturityScoliosis Research Society-22r questionnaire (SRS-22r) ranging from 1 (worst) to 5 (best)
Brace treatmentAt each six-months follow-up and 2, 5, 10 years after skeletal maturityNumber 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.

Countries

Sweden

Contacts

CONTACTElias Diarbakerli, PT, PhD
elias.diarbakerli@regionstockholm.se+460851770000
CONTACTPaul Gerdhem, MD, PhD
paul.gerdhem@uu.se
PRINCIPAL_INVESTIGATORElias Diarbakerli, PT, PhD

Karolinska Institutet

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Aug 28, 2026