1. 2010;13;117-132A Systematic Review on the Effectiveness of the Nucleoplasty Procedure for Discogenic Pain
   Systematic Review
   Stuart R. Lipsitz, ScD, Srdjan S. Nedeljkovic, MD, and Frederic J. Gerges, MD.

BACKGROUND: Nucleoplasty is a minimally invasive procedure for treating pain caused by symptomatic disc herniation that is refractory to conservative therapy. Observational studies have reported differing outcomes for this procedure and thus its effectiveness is yet to be determined.

STUDY DESIGN: A systematic review of the efficacy of the nucleoplasty procedure.

OBJECTIVES: To assess the clinical efficacy of the nucleoplasty procedure for treating back pain from symptomatic, contained disc herniation and to evaluate the methodological quality of the included studies.

METHODS: The relevant literature for nucleoplasty was identified through a search of the following databases: Pubmed, Ovid Medline, and the Cochrane library, and by a review of the bibliographies of the included studies. A review of the literature of the effectiveness of the nucleoplasty procedure for managing discogenic pain was performed according to the criteria for observational studies using a “Quality Index” scale to determine the methodological quality of the literature. The level of evidence was classified as Level I, II, or III based on the quality of evidence developed by the United States Preventive Services Task Force (USPSTF) for therapeutic interventions. Recommendations were based on the criteria developed by Guyatt et al.

OUTCOME MEASURES: The main outcome measures evaluated were the percentage of pain relief based on visual analogue scale (VAS) or numeric rating scale (NRS), percentage of patients with more than 50% reduction in pain, percentage of patients meeting one or more success criteria after nucleoplasty, and improvement in patient function. Secondary measures noted were reports of complications and the Quality Index scores of each study that was evaluated.

RESULTS: The quality of evidence for improvement in pain or function after a nucleoplasty procedure is Level II-3. The recommendation is 1C/strong for the nucleoplasty procedure based on the quality of evidence available. The median Quality Index score was 16 (range 12 - 19), indicating adequate methodological quality of the available literature. None of the studies reported major complications related to nucleoplasty.

CONCLUSIONS: Observational studies suggest that nucleoplasty is a potentially effective minimally invasive treatment for patients with symptomatic disc herniations who are refractory to conservative therapy. The recommendation is a level 1C, strongly supporting the therapeutic efficacy of this procedure. However, prospective randomized controlled trials with higher quality of evidence are necessary to confirm efficacy and risks, and to determine ideal patient selection for this procedure.