Clinical trial NCT05138393: Scoliosis-specific Exercises for Mild Idiopathic Scoliosis
Official title: PREventing Mild Idiopathic SCOliosis PROgression (PREMISCOPRO): a Randomized Controlled Trial Comparing Scoliosis-specific Exercises to Observation in Mild Idiopathic Scoliosis
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Idiopathic Scoliosis
Keywords: Idiopathic scoliosis
Randomized controlled trial
Exercise
Rehabilitation
Self-correction
Lead sponsor: Karolinska Institutet
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2021-12-01
Enrollment: 90
Sex: ALL
Minimum age (years): 9
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Number of patients progressing in curve severity
timeFrame: 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:
measure: Angle of trunk rotation
timeFrame: At each six-month follow-up and at 2, 5, 10 years after skeletal maturity
measure: Patient-reported outcome measures
timeFrame: At each six-months follow-up and 2, 5, 10 years after skeletal maturity
measure: Patient-reported outcome measures
timeFrame: At each six-month follow-up and 2, 5, 10 years after skeletal maturity
measure: Patient-reported outcome measures
timeFrame: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
measure: Patient-reported outcome measures
timeFrame: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity
measure: Brace treatment
timeFrame: At each six-months follow-up and 2, 5, 10 years after skeletal maturity
Other outcomes:
Locations:
city: Linköping
country: Sweden
facility: Linköping university hospital
city: Stockholm
country: Sweden
facility: Karolinska university hospital
Study officials:
affiliation: Karolinska Institutet
name: Elias Diarbakerli, PT, PhD
role: PRINCIPAL_INVESTIGATOR
References: