Trial on Three Treatments for Scoliosis

Idiopathic Scoliosis Clinical Trial

— CONTRAIS  

Official title:

CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis. A Randomised Controlled Trial

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01761305
• Other study ID #: PG-AA-2012-12-19
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 2013
• Est. completion date: December 2030

Study information

• Verified date: October 2023
• Source: Karolinska Institutet
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Idiopathic scoliosis is a three-dimensional structural deformity of the spine that occurs in children. Recent reviews on bracing and exercise treatment have provided some evidence for effect of these interventions. The purpose of this study is to compare the effectiveness of night time bracing, scoliosis specific exercises and physical activity prescription in adolescents with idiopathic scoliosis.

Description:

Today, bracing is used to prevent progression of idiopathic scoliosis in children. The evidence for bracing and physical activity for treatment of idiopathic scoliosis is poor. Only one low quality study has compared bracing with physical exercise, showing no statistical differences in the reduction or progression of scoliosis curves between the groups. To draw valid conclusions about the effectiveness of postural specific physical exercise and brace therapeutic interventions compared to a self mediated activity exercise group, a randomized controlled trial research design will be used. Preliminary data suggests that approximately 8 hours of night-time bracing with an over-corrective brace is as effective as bracing during 23 hours per day. Night-time bracing is attractive since you wear the brace a limited amount of time. Several theories propose that during the adolescent period of skeletal growth, bone deformation may occur due to a combination of asymetrical growth plate activity, vertebral body weakness or an imbalance of muscle forces and joint flexibility. An association between low bone mineral density and idiopathic scoliosis has been reported in the literature. Adequate physical activity levels is a requirement for normal growth and development during childhood and adolescents. It is well documented that physical exercise is associated with improvements in not only muscle strength, aerobic fitness and motor development but also bone density which may help decrease the risk of osteopenic related bone deformation. Patients included in the study will be randomized to one of three groups. Each of the three groups will receive a physical activity prescription according to World Health Organisation recommendations. One group will additionally wear a hyper-corrective night-time brace. One group will additionally perform postural scoliosis-specific exercises. Patients not wanting to be randomized to the alternative treatments in the clinical trial will receive bracing which is the current standard treatment offered. The purpose of the study is to compare the risk of curve progression in the different groups. Curve progression is measured on x-rays. Participation in the study will last until the curve has progressed, or until cessation of skeletal growth. Participants with braces will be instructed to wear the brace 8 hours per night. Participants receiving scoliosis specific training will receive 3x90 minute physiotherapist guided sessions with an additional session provided every 6 months for the entirety of the study. All participants will be recommended to be physically active at least 60 minutes per day.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 135
• Est. completion date: December 2030
• Est. primary completion date: August 29, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 17 Years

Eligibility

Inclusion Criteria:

• Diagnosis of idiopathic scoliosis
• Skeletally immature with estimated remaining growth for at least one year.
• Not more than one year after menarche
• Primary Cobb angle between 25 and 40 degrees.
• Curve apex T7 or caudal

Exclusion Criteria:

• Scoliosis with a possible non-idiopathic ethiology. Patients will be excluded from the study if the pathogenesis of the scoliosis is not idiopathic, but due to a neuromuscular, neurological, congenital malformation or trauma related comorbidity.
• Previous brace or surgical treatment for scoliosis.

Related Conditions & MeSH terms

• Idiopathic Scoliosis
• Scoliosis

Intervention

Procedure:
• Hypercorrective night-time brace
Hypercorrective night-time brace worn 8 hours per night. Patients are encouraged to also continue with non-specific self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour.

Behavioral:
• Scoliosis specific exercises.
The intervention will be delivered in 3 x 90 minute sessions, once per month during the first 3 months. Goals are directed towards active self-correction and postural control, spinal stability, aerobic functioning and development of a positive body image. Additional postural specific exercises including self-mediated hyper-corrective exercises are to be performed with moderate intensity at least for 30 minutes at least 2-3 times per week. Other physical activities to fulfill the general recommended quota of more than 60 minutes moderate intensity physical activity per day are recommended. Reinforcement of the intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour.

Other:
• Self-mediated physical activity.
Instructions for self-mediated physical activity will be delivered during a 1 hour session. Patients are encouraged to perform self-mediated physical activities of moderate intensity at least 60 minutes daily, for the entirety of the study. Reinforcement of the assigned intervention will be performed in conjunction with reassessment every 6 months. A training diary will be implemented to follow and motivate the patient's training behaviour.

Locations

Country	Name	City	State
Sweden	Mälarsjukhuset / Eskilstuna hospital	Eskilstuna
Sweden	Ryhov Hospital	Jönköping
Sweden	Linköping University, Linköping University Hospital	Linköping
Sweden	Karolinska University Hospital	Stockholm
Sweden	Sundsvall Hospital	Sundsvall
Sweden	Umeå University, Norrland University Hospital	Umeå
Sweden	Västerås Hospital	Västerås

Sponsors (5)

Lead Sponsor	Collaborator
Karolinska Institutet	Karolinska University Hospital, Region Stockholm, The Swedish Research Council, University Hospital, Linkoeping

Country where clinical trial is conducted

Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Radiological progression of scoliosis	Progression of the Cobb angle more than 6 degrees, compared to the primary x-ray, seen on two consecutive spinal standing x-rays.	Measured every 6 months, for an expected average of three years
Secondary	Quality of life assessed with questionnaire instruments	Quality of life measured with validated questionnaires such as Euroqol (EQ5D-Y), Scoliosis Research Society outcomes questionnaire 22r (SRS22r), International Physical Activity Questionnaire (IPAQ) and the Walter Reed Visual Assessment Scale.	Measured every 6 months, for an expected average of three years
Secondary	Curve severity at end of study.	Curve severity measured as Cobb angle at end of study.	Measured at end of study, expected at an average of three years after study inclusion
Secondary	Health economic evaluations; actual cost for a treatment	Actual analysis of direct costs, and estimations of indirect costs.	Measured at end of study, expected an average of three years after study inclusion