donna@gigaalaser.com
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.
RESULTS: The primary outcome, Roland-Morris Disability Questionnaire, showed noninferiority of PLDD at 8 ( 0.1; [95% confidence interval (CI), 2.3 to 2.1]) and 52 weeks ( 1.1; 95% CI, 3.4 to 1.1) compared with conventional surgery. There was, however, a higher speed of recovery in favor of conventional surgery (hazard ratio, 0.64 [95% CI, 0.42–0.97]). The number of reoperations was significantly less in the conventional surgery group (38% vs. 16%). Overall, a strategy of PLDD, with delayed surgery if needed, resulted in noninferior outcomes at 1 year.
CONCLUSIONS: At 1 year, a strategy of PLDD, followed by surgery if needed, resulted in noninferior outcomes compared with surgery. 2015 Elsevier Inc. All rights reserved.
donna@gigaalaser.com
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