PREventing Mild Idiopathic SCOliosis PROgression (PREMISCOPRO): a Randomized Controlled Trial Comparing Scoliosis-specific Exercises to Observation in Mild Idiopathic Scoliosis
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 9
Maximum Age: 15
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Sweden
Linköping university hospital
RECRUITING
Linköping
Karolinska university hospital
RECRUITING
Stockholm
Contact Information
Primary
Elias Diarbakerli, PT, PhD
elias.diarbakerli@regionstockholm.se
+460851770000
Backup
Paul Gerdhem, MD, PhD
paul.gerdhem@uu.se
Time Frame
Start Date:2022-02-18
Estimated Completion Date:2037-11-30
Participants
Target number of participants:90
Treatments
Experimental: Active self-corrective exercises
An active self-correction tailored to the individual type of curve and clinical presentation will be applied with the aim to correct the scoliosis in all three planes. Patients will also be informed and educated in task oriented activities of daily living. Training goals are directed towards postural control, spinal stability, muscular stabilization and endurance in corrective postures. Patients will have outpatient sessions once every two weeks the first 3 months and perform the exercises at home in 30-minutes sessions three times per week. Patients are encouraged to continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily. Compliance will be monitored through a mobile application (Physitrack) where the patients record their sessions and can have contact with the research personnel. A cognitive behavioral therapy approach to reinforce physical activity will be performed every 6 months.
Active_comparator: Observation
Patients are encouraged to continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. A cognitive behavioral therapy approach to reinforce physical activity will be performed every 6 months.