Effectiveness of bracing patients with adolescent idiopathic scoliosis

ISRCTN	ISRCTN36964733
DOI	https://doi.org/10.1186/ISRCTN36964733
Secondary identifying numbers	NTR563; ZonMw no. 945-06-354

Submission date: 14/02/2006
Registration date: 14/02/2006
Last edited: 18/08/2009

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Musculoskeletal Diseases

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Record updated in last year

Plain English summary of protocol

Not provided at time of registration

Contact information

Ms E.M. Bunge
Scientific

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

Phone	+31 (0)10 4087498
Email	e.bunge@erasmusmc.nl

Study information

Study design	Multicentre randomised open label active controlled parallel group trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Not specified
Study type	Not Specified
Scientific title
Study objectives	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(s)	Received from local medical ethics committee
Health condition(s) or problem(s) studied	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
Primary outcome measure	Cobb angle, two years after inclusion.
Secondary outcome measures	1. Quality of life 2. Patient preferences 3. Costs
Overall study start date	19/01/2006
Completion date	31/03/2009

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	8 Years
Upper age limit	15 Years
Sex	Both
Target number of participants	100
Key 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.
Key exclusion criteria	Patients with other forms of scoliosis (e.g. as a result of neuromuscular diseases)
Date of first enrolment	19/01/2006
Date of final enrolment	31/03/2009

Locations

Countries of recruitment

Netherlands

Study participating centre

Erasmus Medical Centre

Rotterdam
3000 DR
Netherlands

Sponsor information

Erasmus Medical Centre (Netherlands)
Hospital/treatment centre

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

"ROR"	https://ror.org/018906e22

Funders

Funder type

Research organisation

Netherlands Organisation for Health Research and Development (ZonMw) (Netherlands)
Private sector organisation / Other non-profit organizations

Alternative name(s): Netherlands Organisation for Health Research and Development
Location: Netherlands

Erasmus University Rotterdam (Association trust fund [Vereniging Trustfonds]) (Netherlands)
Government organisation / Universities (academic only)

Alternative name(s): Erasmus University Rotterdam, Erasmus Universiteit, EUR
Location: Netherlands

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

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
Publication and dissemination plan	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Protocol article	Protocol	22/04/2008		Yes	No