|- candidate number||8065|
|- NTR Number||NTR2333|
|- ISRCTN||ISRCTN wordt niet meer aangevraagd.|
|- Date ISRCTN created|
|- date ISRCTN requested|
|- Date Registered NTR||14-mei-2010|
|- Secondary IDs||945-02-0351 LUMC|
|- Public Title||Study to the effectiveness of audio-visual aids for patients with a lumbar disc herniation.|
|- Scientific Title||Dissemination and implementation of the results of the "Sciatica Trial, a multicentre randomised cost-effectiveness trial concerning the timing of surgery for sciatica caused by a lumbar disc herniation". ISRCTN26872154.|
|- hypothesis||The individual patient can make a well-informed choice for a treatment by using audio-visual aids.|
|- Healt Condition(s) or Problem(s) studied||Lumbar disk, Hernia, Sciatica|
|- Inclusion criteria||1. Age 18-75 years old;|
2. Unilateral lumbosacralis radiculair syndrome;
3. An indication for surgery is made by the clinical picture with magnetic resonance imaging (MRI) confirmation of a lumbar disc herniation.
|- Exclusion criteria||1. Cauda equina syndrome;|
2. Severe paresis (MRC less than 3);
3. A history of spine surgery, bony stenosis, spondylolisthesis;
4. Severe comorbidity.
|- mec approval received||no|
|- multicenter trial||yes|
|- Type||2 or more arms, randomized|
|- planned startdate ||1-jul-2009|
|- planned closingdate||1-jul-2011|
|- Target number of participants||300|
|- Interventions||Purpose of this study is to test two expedients, an audio-visual aid and a web page (www.kiesbeter.nl). |
|- Primary outcome||Patient satisfaction with the treatment choice.|
|- Secondary outcome||1. To what extent the patient is informed?|
2. To what extent the audio-visual aids have an effect on the decision and decision process of the patient.
|- Timepoints||Follow up will be performed 1x directly after the first visit to the outpatients' clinic, 1x before the second visit to the outpatients' clinic. One week, 6 and 12 months after the second outpatient clinic visit.|
|- Trial web site||www.lumc.nl/SIPS|
|- status||open: patient inclusion|
|- CONTACT FOR PUBLIC QUERIES|| SIPS-group Leiden-The Hague|
|- CONTACT for SCIENTIFIC QUERIES||Mw. dr. M. Vries, de|
|- Sponsor/Initiator ||Leiden University Medical Center (LUMC)|
(Source(s) of Monetary or Material Support)
|ZON-MW, The Netherlands Organization for Health Research and Development|
|- Brief summary||Increasingly patients will be encouraged to take an active part in the medical decision concerning their own health. To make a well-informed choice for a presently surgery or prolonged conservative treatment, the patient should have a good insight to the pros and cons of the several treatments. |
With this, an decision aid can be a good help.
Purpose of this study is to test two expedients, an audio-visual aid and a web page (www.kiesbeter.nl).
|- Main changes (audit trail)|
|- RECORD||14-mei-2010 - 29-jul-2010|