Nucleoplasty, a minimally invasive procedure for disc decompression: a systematic review and meta-analysis of published clinical studies.

BACKGROUND Nucleoplasty, based on Coblation® technology, is a minimally invasive procedure used to decompress herniated discs. Reviews to date--exclusively systematic reviews--recommend nucleoplasty for treating chronic back pain, although with the restriction of limited to fair evidence. We therefore aimed to summarize and interpret our calculated results, where possible comprehensively and quantitatively, using statistical methods in the context of a meta-analysis supplementing a systematic review. In the process, the central question was to statistically determine whether, and to what extent, nucleoplasty can positively affect pain relief and functional mobility as well as lower the complication rate. OBJECTIVE Newly published studies made it possible to conduct a meta-analysis of the visual analog scale (VAS), a measuring instrument used to determine pain intensity, and the Oswestry Disability Index (ODI), a scale that reflects the degree of impairment in percent. In addition to having clearly sound evidence for analyzing VAS/NPS data, the present, newly compiled meta-analysis was able to summarize VAS and ODI data quantitatively and to calculate a total complication rate for the first time. It was thereby possible to make a first comparison between nucleoplasty and conservative therapy (including epidural steroid injection). STUDY DESIGN This meta-analysis examined all study data published in clinical trials involving the nucleoplasty procedure for plasma disc decompression. METHODS A systematic search using the terms nucleoplasty and/or plasma disc decompression was conducted for literature listed in MEDLINE. Twenty-seven eligible studies (22 prospective trials and 5 retrospective trials) were included, and pooled analyses as well as various subgroup analyses (differentiation between cervical and lumbar disc herniations, comparisons with alternative treatments such as epidural steroid injection) were performed based on their data. RESULTS Pain decreased from a baseline VAS value of 7.27 to 2.12 (postop/first day), 2.50 (one week), 2.70 (2 weeks), 3.23 (one month), 2.66 (6 weeks), 2.84 (3 months), 3.06 (6 months), 3.03 (12 months), 1.54 (18 months), and 3.69 (24 months) after nucleoplasty. The ODI value (baseline: 58.95) dropped to 28.60 (one week), 29.00 (2 weeks), 23.21 (one month), 30.00 (6 weeks), 18.30 (3 months), 22.54 (6 months), 24.43 (12 months), 12.82 (18 months), and 36.98 (24 months). Compared to baseline, significant pain reduction and improvement in functional mobility after nucleoplasty were observed at every time point. Nucleoplasty showed a total complication rate of 1.5%, with the individual rates being 0.8% for cervical and 1.8% for lumbar nucleoplasty. Nucleoplasty was superior to conservative therapy at every time point and for all 3 included parameters, at some measurement time points even significantly. CONCLUSIONS Nucleoplasty reduces pain in the long term and improves patients' functional mobility. It is an effective, low-complication, minimally invasive procedure used to treat disc herniations.