Trial on Three Treatments for Scoliosis

NCT01761305 | Active Not Recruiting DMC

• 1 other identifier: PG-AA-2012-12-19
• Study Type: interventional
• Target: 135
• Locations: 1 country
• Sites: 7

Brief 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

Keywords

Idiopathic scoliosis; Brace; Scoliosis specific exercise; Physical activity

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Quality of life assessed with questionnaire instruments

  Measured every 6 months, for an expected average of three years

• Curve severity at end of study.

  Measured at end of study, expected at an average of three years after study inclusion

• Health economic evaluations; actual cost for a treatment

  Measured at end of study, expected an average of three years after study inclusion

• Neuroaxial abnormalities and risk of curve progression

  Analysed when magnetic resonance images are available and all participants has arrived to the primary endpoint of the study

• Curve severity comparing night time brace and full time brace

  From brace initiation until skeletal maturity (estimated to about 3 years after inclusion), and 2, 5 and 10 years after skeletal maturity

Study Arms (3)

Brace

EXPERIMENTAL

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

Scoliosis specific exercises.

EXPERIMENTAL

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.

Self-mediated physical activity.

ACTIVE COMPARATOR

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.

Interventions

Hypercorrective night-time brace PROCEDURE

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.

Brace

Scoliosis specific exercises. BEHAVIORAL

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.

Scoliosis specific exercises.

Self-mediated physical activity. OTHER

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.

Self-mediated physical activity.

Eligibility Criteria

• Age: 9 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Karolinska Institutet: lead
• Karolinska University Hospital: collaborator
• Region Stockholm: collaborator
• The Swedish Research Council: collaborator
• University Hospital, Linkoeping: collaborator

Study Sites (7)

Mälarsjukhuset / Eskilstuna hospital

Eskilstuna, 63188, Sweden

Location

Ryhov Hospital

Jönköping, 55185, Sweden

Location

Linköping University, Linköping University Hospital

Linköping, 58183, Sweden

Location

Karolinska University Hospital

Stockholm, 14186, Sweden

Location

Sundsvall Hospital

Sundsvall, 85186, Sweden

Location

Umeå University, Norrland University Hospital

Umeå, 90185, Sweden

Location

Västerås Hospital

Västerås, 72189, Sweden

Location

Related Publications (2)

• Charalampidis A, Diarbakerli E, Dufvenberg M, Jalalpour K, Ohlin A, Ahl AA, Moller H, Abbott A, Gerdhem P; CONTRAIS Study Group. Nighttime Bracing or Exercise in Moderate-Grade Adolescent Idiopathic Scoliosis: A Randomized Clinical Trial. JAMA Netw Open. 2024 Jan 2;7(1):e2352492. doi: 10.1001/jamanetworkopen.2023.52492.

  PMID: 38285447 DERIVED

• Abbott A, Moller H, Gerdhem P. CONTRAIS: CONservative TReatment for Adolescent Idiopathic Scoliosis: a randomised controlled trial protocol. BMC Musculoskelet Disord. 2013 Sep 5;14:261. doi: 10.1186/1471-2474-14-261.

  PMID: 24007599 DERIVED

MeSH Terms

Conditions

Motor Activity

Condition Hierarchy (Ancestors)

Behavior

Study Officials

• Paul Gerdhem, MD, PhD

  Karolinska Institutet, Karolinska University Hospital

  PRINCIPAL INVESTIGATOR

• Allan Abbott, MPhyt, PhD

  Linköping University- Sweden, Linköping and Karolinska University Hospital - Sweden

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Professor

Study Record Dates

• First Submitted: December 28, 2012
• First Posted: January 4, 2013
• Study Start: January 1, 2013
• Primary Completion: August 29, 2021
• Study Completion (Estimated): December 1, 2030
• Last Updated: February 21, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: At the time of publication
• Access Criteria: Data will be made available upon reasonable request.

Locations

SE (7)