Abstract
BACKGROUND: Intervertebral disc herniation is a major cause of low back pain. Several treatment methods are available for lumbar disc herniation including Chemonucleolysis, open surgery, nucleoplasty, laser disc decompression, and intradiscal electrothermal therapy. The high prevalence of lumbar disc herniation necessitates a minimally invasive yet effective treatment method. In this study, we compared the outcomes of open surgery and nucleoplasty method in patients with single lumbar disc herniation. MATERIALS AND METHODS: This study was a noninferiority randomized clinical trial conducted in one of the University Hospitals of Isfahan Medical University; The Alzahra Hospital. About 200 patients with the diagnosis of lumbar disc herniation were recruited and were assigned to either the treatment or control groups using block randomization. One group received open surgery and the other group received nucleoplasty as the method of treatment. Patients were revisited at 14 days, 1, 2, 3 months, and 1-year after surgery and were assessed for the following variables: Lower back pain, lower limb pain, common complications of surgery (e.g., discitis, infection and hematoma) and recurrence of herniation. RESULTS: The mean (standard deviation) severity of low back pain was reduced from 6.92 (2.5) to 3.43 (2.3) in the nucleoplasty group (P = 0.04) and from 7.5 (2.2) to 3.04 (1.61) in the discectomy group (P = 0.73). Between group difference was not statistically significant (P = 0.44), however, time and treatment interaction was significant (P = 0.001). The level of radicular pain evaluated 1 year after treatment was reduced from 8.1 (1.2) to 2.9 (1.2) (P = 0.004) and from 7.89 (2.1) to 3.6 (2.5) (P =0.04) in the discectomy and the nucleoplasty groups respectively, significant interaction between time and treatment options was observed (P < 0.001) while there was no significant difference between two treatment groups (P = 0.82). CONCLUSION: Our results show that while nucleoplasty is as effective as open discectomy in the treatment of lumbar disc herniation, it is also less invasive with higher patient compliance. Taking factor such as decreased cost and duration of the surgery, as well as faster recovery in patients into account; we suggest considering nucleoplasty as an effective method of treatment in patients with single-level disc herniation.