BACKGROUND CONTEXT: Percutaneous laser disc decompression (PLDD) is a minimally invasive treatment for lumbar disc herniation, with Food and Drug Administration approval since 1991.
However, no randomized trial comparing PLDD to conventional treatment has been performed.
PURPOSE: In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery.
STUDY DESIGN/SETTING: This randomized prospective trial with a noninferiority design was carried out in two academic and six teaching hospitals in the Netherlands according to an intent-totreat protocol with full institutional review board approval.
PATIENT SAMPLE: One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included.
OUTCOME MEASURES: The main outcome measures for this trial were the Roland-Morris Disability Questionnaire for sciatica, visual analog scores for back and leg pain, and the patient’s report of perceived recovery.
METHODS: Patients were randomly allocated to PLDD (n557) or conventional surgery (n558).Blinding was impossible because of the nature of the interventions. This study was funded by the Healthcare Insurance Board of the Netherlands
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donna@gigaalaser.com
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