Trial on Three Treatments for Scoliosis

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.

Conditions

• Idiopathic Scoliosis

Interventions

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.

Sponsors & Collaborators

• Karolinska University Hospital

  collaborator OTHER

• Region Stockholm

  collaborator OTHER_GOV

• The Swedish Research Council

  collaborator OTHER_GOV

• University Hospital, Linkoeping

  collaborator OTHER

• Karolinska Institutet

  lead OTHER

Principal Investigators

• Paul Gerdhem, MD, PhD · Karolinska Institutet, Karolinska University Hospital

• Allan Abbott, MPhyt, PhD · Linköping University- Sweden, Linköping and Karolinska University Hospital - Sweden

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

9 Years

Max Age

17 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2013-01-31

Primary Completion

2021-08-29

Completion

2030-12-31

Countries

• Sweden

Study Locations