Trial on Three Treatments for Scoliosis (CONTRAIS)

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2013 by Karolinska Institutet
Sponsor:
Collaborators:
Karolinska University Hospital
Stockholm County Council, Sweden
The Swedish Research Council
Information provided by (Responsible Party):
Paul Gerdhem, Karolinska Institutet
ClinicalTrials.gov Identifier:
NCT01761305
First received: December 28, 2012
Last updated: January 8, 2013
Last verified: January 2013
  Purpose

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.


Condition Intervention
Idiopathic Scoliosis
Procedure: Hypercorrective night-time brace
Behavioral: Scoliosis specific exercises.
Other: Self-mediated physical activity.

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis. A Randomised Controlled Trial

Resource links provided by NLM:


Further study details as provided by Karolinska Institutet:

Primary Outcome Measures:
  • Radiological progression of scoliosis [ Time Frame: Measured every 6 months, for an expected average of three years ] [ Designated as safety issue: No ]
    Progression of the Cobb angle more than 6 degrees, compared to the primary x-ray, seen on two consecutive spinal standing x-rays taken with 6 months interval.


Secondary Outcome Measures:
  • Quality of life [ Time Frame: Measured every 6 months, for an expected average of three years ] [ Designated as safety issue: No ]
    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.

  • Curve severity at end of study. [ Time Frame: Measured at end of study, expected at an average of three years after study inclusion ] [ Designated as safety issue: No ]
    Curve severity measured as Cobb angle at end of study.


Estimated Enrollment: 135
Study Start Date: January 2013
Estimated Study Completion Date: January 2019
Estimated Primary Completion Date: January 2019 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Brace
Hypercorrective night-time brace worn 8 hours per night. A prescription of general physical activity will be provided at a dose of 60 minutes per day. Instructions regarding physical activity will be delivered during a one hour session.
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.
Experimental: Scoliosis specific exercises.
Scoliosis specific exercises. The intervention will be delivered in 3 x 90 minute sessions, once per month during the first 3 months. An additional session will be provided every 6 months for the entirety of the study. A prescription of general physical activity will be provided at a dose of 60 minutes per day.
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.
Active Comparator: Self-mediated physical activity.
A prescription of general physical activity will be provided at a dose of 60 minutes per day. Instructions will be delivered during a 1 hour session.
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.

Detailed 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.

  Eligibility

Ages Eligible for Study:   9 Years to 17 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761305

Contacts
Contact: Paul Gerdhem, MD, PhD +46736994409 paul.gerdhem@karolinska.se
Contact: Allan Abbott, MPhyt, PhD +46733816914 allan.abbott@karolinska.se

Locations
Sweden
Karolinska University Hospital Recruiting
Stockholm, Sweden, 14186
Principal Investigator: Paul Gerdhem, MD, PhD         
Principal Investigator: Allan Abbott, MPhyt, PhD         
Sub-Investigator: Hans Möller, MD, PhD         
Sponsors and Collaborators
Karolinska Institutet
Karolinska University Hospital
Stockholm County Council, Sweden
The Swedish Research Council
Investigators
Principal Investigator: Paul Gerdhem, MD, PhD Karolinska Institutet, Karolinska University Hospital
Study Director: Allan Abbott, MPhyt, PhD Karolinska Institutet - Sweden, Karolinska University Hospital - Sweden, Bond University - Australia
  More Information

No publications provided by Karolinska Institutet

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Paul Gerdhem, MD, PhD, Assoc Professor, Karolinska Institutet
ClinicalTrials.gov Identifier: NCT01761305     History of Changes
Other Study ID Numbers: PG-AA-2012-12-19
Study First Received: December 28, 2012
Last Updated: January 8, 2013
Health Authority: Sweden: Institutional Review Board

Keywords provided by Karolinska Institutet:
Idiopathic scoliosis
Brace
Scoliosis specific exercise
Physical activity

Additional relevant MeSH terms:
Scoliosis
Spinal Curvatures
Spinal Diseases
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on September 30, 2014