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NCT Number: NCT05138393

Scoliosis-specific Exercises for 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.

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Key information

Age range

9 year–15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Linköping university hospital, Linköping, Sweden

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Active self-corrective exercises

Other

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

observation

Other

Non-specific physical activity 60 minutes per day.

Primary outcomes

  1. 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

Secondary outcomes

  1. Angle of trunk rotation

    Time frame: At each six-month follow-up and at 2, 5, 10 years after skeletal maturity

    Angle of trunk rotation in forward bending, assessed according to Adams forward bending test with Bunnell's scoliometer

  2. Patient-reported outcome measures

    Time frame: At each six-months follow-up and 2, 5, 10 years after skeletal maturity

    Scoliosis Research Society-22r questionnaire (SRS-22r) ranging from 1 (worst) to 5 (best)

  3. Patient-reported outcome measures

    Time frame: At each six-month follow-up and 2, 5, 10 years after skeletal maturity

    The child-friendly EQ-5D version (EQ-5D-Y) with values ranging from 1 (best) to 3 (worst)

  4. Patient-reported outcome measures

    Time frame: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity

    Pictorial part of Spinal Appearance Questionnaire (pSAQ) with values ranging from 7 (best) to 35 (worst)

  5. Patient-reported outcome measures

    Time frame: At each six-month follow-up, and 2, 5, 10 years after skeletal maturity

    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

  6. Brace treatment

    Time frame: At each six-months follow-up and 2, 5, 10 years after skeletal maturity

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Elias Diarbakerli, PT, PhD

CONTACT

[email protected]

+460851770000

Paul Gerdhem, MD, PhD

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Karolinska Institutet

Other

Collaborators

  • Linkoeping University

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2027
Study completion
2037
First posted
Dec 1, 2021
Registry last updated
Feb 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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