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 measure
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 (if study stopped)
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
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
Basic results (scientific)
Publication list
Protocol in http://www.ncbi.nlm.nih.gov/pubmed/18430217
Publication citations
-
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.