Scoliosis-specific Exercises for Mild Idiopathic Scoliosis
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Active self-corrective exercises, Observation.
- Who it may be relevant to
- Registry conditions: Idiopathic Scoliosis. Basic parameters: 9 years — 15 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Sweden
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
PREventing Mild Idiopathic SCOliosis PROgression (PREMISCOPRO): a Randomized Controlled Trial Comparing Scoliosis-specific Exercises to Observation in Mild Idiopathic Scoliosis
Overview
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
- Other Active self-corrective exercises
Scoliosis specific exercises with an Active self-corrective approach. Non-specific physical activity 60 minutes per day. - Other Observation
Non-specific physical activity 60 minutes per day.
Primary outcome measures
- 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]
Secondary outcome measures (6)
- 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]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Sweden · 2 centers
- Linköping university hospital — Linköping
- Karolinska university hospital — Stockholm
Identifiers
NCT: NCT05138393 · ED-PG-AA-2021-SSE