Scoliosis-specific Exercises for Mild Idiopathic Scoliosis
ConditionIdiopathic Scoliosis
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age9-15
SponsorKarolinska Institutet
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Cobb 15-24 degrees
Skeletally immature, Sanders score of 4 or less and Risser < 2.
No menarche for females
Aged 9-15 years
Disqualifiers
Non-idiopathic scoliosis (i.e. neuromuscular, syndromic or congenital scoliosis)
No previous surgical or brace treatment for scoliosis
Trial design
Design model
Parallel
Treatments tested in this trial
Active self-corrective exercises
Other interventionScoliosis specific exercises with an Active self-corrective approach. Non-specific physical activity 60 minutes per day.
Observation
Other interventionNon-specific physical activity 60 minutes per day.
Treatment groups
90 Participants
are divided into 2 treatment groupsGroup A: Active self-corrective exercisesExperimental treatment 1 intervention
Group B: ObservationActive comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
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 monthsSecondary outcomes
1
Angle of trunk rotation
Angle of trunk rotation in forward bending, assessed according to Adams forward bending test with Bunnell's scoliometer
Time frame
At each six-month follow-up and at 2, 5, 10 years after skeletal maturity2
Patient-reported outcome measures
Scoliosis Research Society-22r questionnaire (SRS-22r) ranging from 1 (worst) to 5 (best)
Time frame
At each six-months follow-up and 2, 5, 10 years after skeletal maturity3
Patient-reported outcome measures
The child-friendly EQ-5D version (EQ-5D-Y) with values ranging from 1 (best) to 3 (worst)
Time frame
At each six-month follow-up and 2, 5, 10 years after skeletal maturity4
Patient-reported outcome measures
Pictorial part of Spinal Appearance Questionnaire (pSAQ) with values ranging from 7 (best) to 35 (worst)
Time frame
At each six-month follow-up, and 2, 5, 10 years after skeletal maturitySponsors and contacts
Click on the lead sponsor to view all of their trials.
Karolinska Institutet
Lead sponsor
Linkoeping University
Collaborator
Source ClinicalTrials.gov