Percutaneous laser disc decompression versus conventional microdiscectomy in sciatica: a randomized controlled trial

Patrick A Brouwer; Ronald Brand; M Elske van den Akker-van Marle; Wilco C H Jacobs; Barry Schenk; Annette A van den Berg-Huijsmans; Bart W Koes; M A van Buchem; Mark P Arts; Wilco C Peul

doi:10.1016/j.spinee.2015.01.020

Percutaneous laser disc decompression versus conventional microdiscectomy in sciatica: a randomized controlled trial

Spine J. 2015 May 1;15(5):857-65. doi: 10.1016/j.spinee.2015.01.020. Epub 2015 Jan 20.

Affiliations

¹ Department of Radiology, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
² Department of Medical Statistics and Bioinformatics, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
³ Department of Decision Making, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands.
⁴ Department of Neurosurgery, Leiden University Medical Center, PO Box 9600, 2300 RC, Leiden, The Netherlands. Electronic address: [email protected].
⁵ Department of General Practice, Erasmus MC, University Medical Center, Wytemaweg 80, 3015 CN, Rotterdam, The Netherlands.
⁶ 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.

PMID: 25614151
DOI: 10.1016/j.spinee.2015.01.020

Abstract

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-to-treat 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 (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.

Keywords: Disc herniation; Discectomy; Minimal invasive techniques; Percutaneous disc decompression; Randomized clinical trial; Sciatica.

Publication types

Comparative Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

MeSH terms

Adult
Aged
Decompression, Surgical / adverse effects
Decompression, Surgical / methods*
Diskectomy / adverse effects
Diskectomy / methods*
Female
Humans
Intervertebral Disc Displacement / surgery
Laser Therapy / methods
Lumbar Vertebrae / surgery
Male
Middle Aged
Minimally Invasive Surgical Procedures / methods
Prospective Studies
Sciatica / surgery*