title: Percutaneous laser disc decompression versus conventional microdiscectomy in sciatica: a randomized controlled trial.
abstract: BACKGROUND
  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.
  
  
  OBJECTIVE
  In this trial, we assessed the effectiveness of a strategy of PLDD as compared with conventional surgery.
  
  
  METHODS
  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-to-treat protocol with full institutional review board approval.
  
  
  METHODS
  One hundred fifteen eligible surgical candidates, with sciatica from a disc herniation smaller than one-third of the spinal canal, were included.
  
  
  METHODS
  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 (n=57) or conventional surgery (n=58). 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.
authors.affiliation: Department of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
authors.forename: Patrick A
authors.initials: PA
authors.lastname: Brouwer
authors.affiliation: Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
authors.forename: Ronald
authors.initials: R
authors.lastname: Brand
authors.affiliation: Department of Decision Making, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
authors.forename: M Elske
authors.initials: ME
authors.lastname: van den Akker-van Marle
authors.affiliation: Department of Neurosurgery, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands. Electronic address: w.c.h.jacobs@lumc.nl.
authors.forename: Wilco C H
authors.initials: WC
authors.lastname: Jacobs
authors.affiliation: Department of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
authors.forename: Barry
authors.initials: B
authors.lastname: Schenk
authors.affiliation: Department of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
authors.forename: Annette A
authors.initials: AA
authors.lastname: van den Berg-Huijsmans
authors.affiliation: Department of General Practice, Erasmus MC, University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.
authors.forename: Bart W
authors.initials: BW
authors.lastname: Koes
authors.affiliation: Department of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
authors.forename: M A
authors.initials: MA
authors.lastname: van Buchem
authors.affiliation: Department of Neurosurgery, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands; Department of Neurosurgery, Medical Center Haaglanden The Hague & Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
authors.forename: Mark P
authors.initials: MP
authors.lastname: Arts
authors.affiliation: Department of Neurosurgery, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands; Department of Neurosurgery, Medical Center Haaglanden The Hague & Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
authors.forename: Wilco C
authors.initials: WC
authors.lastname: Peul
mesh_terms: D000328:Adult; D000368:Aged; D019299:Decompression, Surgical / Q000009:adverse effects / Q000379:methods*; D017586:Diskectomy / Q000009:adverse effects / Q000379:methods*; D005260:Female; D006801:Humans; D007405:Intervertebral Disc Displacement / Q000601:surgery; D053685:Laser Therapy / Q000379:methods; D008159:Lumbar Vertebrae / Q000601:surgery; D008297:Male; D008875:Middle Aged; D019060:Minimally Invasive Surgical Procedures / Q000379:methods; D011446:Prospective Studies; D012585:Sciatica / Q000601:surgery*
keywords: Disc herniation; Discectomy; Minimal invasive techniques; Percutaneous disc decompression; Randomized clinical trial; Sciatica