Efficacy of spinal orthosis in nonsurgical treatment of traumatic thoracolumbar fractures

Treatment of thoracolumbar traumatic fractures consists of early mobilization
with the aid of a physiotherapist and analgesics, commonly supported by the use
of an orthosis. Untill this date there is no scientific evidence that supports
the use of an orthosis. Commonly it is assumed that the orthosis diminishes the
pain and prevents patients to hyperflex of -extend the spinal column.
The goal of this study is to evaluate that assumption.

The withhold of the use of a spinal orthosis for traumatic spinal fractures
will lead to equal pain, radiologic outcome, and quality of life (QoL) in
patients.

Prospective multicentre randomized controlled clinical trial. All patients with
a traumatic stable thoracolumbar fracture of the spine older than 18 years,
whith informed consent, are included. Group 1 is the intervention group and
will be wearing an orthosis for 12 weeks, Group 2 serves as a control group and
will be treated without an orthosis. Follow up visits are scheduled at 1 week,
6 weeks, 3 months, 6 months and 1 year.
Simultaneously at each visit a VAS, Queleffo and Roland Morrison Questionnaire
will be registered. In both groups X-rays will be performed in
posterieur-anterior and lateral images, at day 0, 1 week, 6 weeks, 3 months, 6
months and 1 year.
The local sagittal angle and the loss of height will be measured by a
radiologist.
Both groups recieve the same follow up, painmedication and fysiotherapy.

a spinal orthosis to wear for 12 weeks

The follow up appointments take more time to fill in the VAS en the Queleffo
questionnaires. The patient will visit the outpatientclinic for one year in 5
visits. In the regular follow up after a thoracolumbar fracture this can
involve a shorter follow up period and one less visit.
In literature there is no evidence that treatment with or without an orthosis
is associated with any risks