Condition category
Musculoskeletal Diseases
Date applied
14/02/2006
Date assigned
14/02/2006
Last edited
18/08/2009
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Ms E.M. Bunge

ORCID ID

Contact details

Erasmus Medical Centre
Department of Public Health
P.O. Box 1738
Rotterdam
3000 DR
Netherlands
+31 (0)10 4087498
e.bunge@erasmusmc.nl

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

NTR563; ZonMw no. 945-06-354

Study information

Scientific title

Acronym

Study hypothesis

Bracing patients with adolescent idiopathic scoliosis in an early stage results in at least 5 degrees less mean progression of the curvature compared to the control group after two years of follow up.

Ethics approval

Received from local medical ethics committee

Study design

Multicentre randomised open label active controlled parallel group trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Not Specified

Patient information sheet

Condition

Adolescent Idiopathic Scoliosis (AIS)

Intervention

Patients in the intervention group will be treated with a brace. The brace is a device that fits closely around the body to exert pressure to the trunk in order to push the spine into a straighter position. The patients will be advised to wear the brace every day for 18-23 hours. Patients are allowed to go to physiotherapy if they want to, but this is not obligatory. Patients of the control group will initially not be braced during the two study years, unless their curvature shows more than 10 degrees progression compared to the Cobb angle at inclusion. The patients of the control group are allowed to go to physical therapy, because physical therapy alone will not prevent further progression of the curvature. The orthopaedic surgeons will examine all patients every four months, amongst other things by X-ray.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

Cobb angle, two years after inclusion.

Secondary outcome measures

1. Quality of life
2. Patient preferences
3. Costs

Overall trial start date

19/01/2006

Overall trial end date

31/03/2009

Reason abandoned

Eligibility

Participant inclusion criteria

1. Firls and boys in the age group 8-15 years
2. Diagnosis of AIS has been established by an orthopaedic surgeon
3. not yet been treated by bracing or surgery
4. Further growth of physical height is still expected based on medical examination and maturation characteristics (Risser sign) established by X-ray. To expect further growth of physical height, patients only with Risser sign <3 will be included.
5. As agreed in the consensus by the different health professionals in the orthopaedic field, the Cobb angle should either be minimally 22 and maximally 29 degrees with established progression of more than 5 degrees or should be minimally 30 and maximally 35 degrees; progression for the latter is not necessarily established.

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

100

Participant exclusion criteria

Patients with other forms of scoliosis (e.g. as a result of neuromuscular diseases)

Recruitment start date

19/01/2006

Recruitment end date

31/03/2009

Locations

Countries of recruitment

Netherlands

Trial participating centre

Erasmus Medical Centre
Rotterdam
3000 DR
Netherlands

Sponsor information

Organisation

Erasmus Medical Centre (Netherlands)

Sponsor details

Department of Public Health
P.O. Box 1738
Rotterdam
3000 DR
Netherlands

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Research organisation

Funder name

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)

Alternative name(s)

Netherlands Organisation for Health Research and Development

Funding Body Type

private sector organisation

Funding Body Subtype

other non-profit

Location

Netherlands

Funder name

Erasmus University Rotterdam (Association trust fund [Vereniging Trustfonds]) (Netherlands)

Alternative name(s)

Erasmus University Rotterdam, Erasmus Universiteit, EUR

Funding Body Type

private sector organisation

Funding Body Subtype

academic

Location

Netherlands

Funder name

The Nuts Ohra Foundation (Stichting Nuts Ohra) (Netherlands)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18430217

Publication citations

  1. Protocol

    Bunge EM, de Koning HJ, , Bracing patients with idiopathic scoliosis: design of the Dutch randomized controlled treatment trial., BMC Musculoskelet Disord, 2008, 9, 57, doi: 10.1186/1471-2474-9-57.

Additional files

Editorial Notes