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Study to the effectiveness of audio-visual aids for patients with a lumbar disc herniation.


- candidate number8065
- NTR NumberNTR2333
- ISRCTNISRCTN wordt niet meer aangevraagd.
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR14-mei-2010
- Secondary IDs945-02-0351 LUMC
- Public TitleStudy to the effectiveness of audio-visual aids for patients with a lumbar disc herniation.
- Scientific TitleDissemination 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.
- ACRONYMVIS
- hypothesisThe individual patient can make a well-informed choice for a treatment by using audio-visual aids.
- Healt Condition(s) or Problem(s) studiedLumbar disk, Hernia, Sciatica
- Inclusion criteria1. 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 criteria1. Cauda equina syndrome;
2. Severe paresis (MRC less than 3);
3. A history of spine surgery, bony stenosis, spondylolisthesis;
4. Severe comorbidity.
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlActive
- groupParallel
- Type2 or more arms, randomized
- Studytypeobservational
- planned startdate 1-jul-2009
- planned closingdate1-jul-2011
- Target number of participants300
- InterventionsPurpose of this study is to test two expedients, an audio-visual aid and a web page (www.kiesbeter.nl).
- Primary outcomePatient satisfaction with the treatment choice.
- Secondary outcome1. 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.
- TimepointsFollow 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 sitewww.lumc.nl/SIPS
- statusopen: patient inclusion
- CONTACT FOR PUBLIC QUERIES SIPS-group Leiden-The Hague
- CONTACT for SCIENTIFIC QUERIESMw. dr. M. Vries, de
- Sponsor/Initiator Leiden University Medical Center (LUMC)
- Funding
(Source(s) of Monetary or Material Support)
ZON-MW, The Netherlands Organization for Health Research and Development
- PublicationsN/A
- Brief summaryIncreasingly 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)
- RECORD14-mei-2010 - 29-jul-2010


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