Abrishamkar Saeid, Kouchakzadeh Masih, Mirhosseini Ahmad, Tabesh Homayoun, Rezvani Majid, Moayednia Amir, Ganjeifar Babak, Mahabadi Amir, Yousefi Elham, Kooshki Ali Mehrabi
Department of Neurosurgery, Isfahan University of Medical Sciences, Isfahan, Iran.
Department of Physical Medicine and Rehabilitation, Isfahan University of Medical Sciences, Isfahan, Iran.
J Res Med Sci. 2015 Dec;20(12):1133-7. doi: 10.4103/1735-1995.172979.
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.
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.
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).
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.
椎间盘突出是腰痛的主要原因。腰椎间盘突出症有多种治疗方法,包括化学溶核术、开放手术、髓核成形术、激光椎间盘减压术和椎间盘内电热疗法。腰椎间盘突出症的高发病率需要一种微创且有效的治疗方法。在本研究中,我们比较了开放手术和髓核成形术治疗单节段腰椎间盘突出症患者的疗效。
本研究是在伊斯法罕医科大学的一所大学医院——阿尔扎赫拉医院进行的一项非劣效性随机临床试验。招募了约200例诊断为腰椎间盘突出症的患者,并采用区组随机化将其分为治疗组或对照组。一组接受开放手术,另一组接受髓核成形术作为治疗方法。术后14天、1个月、2个月、3个月和1年对患者进行复查,并评估以下变量:腰痛、下肢疼痛、手术常见并发症(如椎间盘炎、感染和血肿)以及椎间盘突出复发情况。
髓核成形术组腰痛的平均(标准差)严重程度从6.92(2.5)降至3.43(2.3)(P = 0.04),椎间盘切除术组从7.5(2.2)降至3.04(1.61)(P = 0.73)。组间差异无统计学意义(P = 0.44),然而,时间与治疗的交互作用具有统计学意义(P = 0.001)。治疗1年后评估的神经根性疼痛水平,椎间盘切除术组从8.1(1.2)降至2.9(1.2)(P = 0.004),髓核成形术组从7.89(2.1)降至3.6(2.5)(P = 0.04),观察到时间与治疗方案之间存在显著交互作用(P < 0.001),而两个治疗组之间无显著差异(P = 0.82)。
我们的结果表明,虽然髓核成形术在治疗腰椎间盘突出症方面与开放椎间盘切除术一样有效,但它的侵入性更小,患者依从性更高。考虑到手术成本降低、手术时间缩短以及患者恢复更快等因素;我们建议将髓核成形术视为单节段椎间盘突出症患者的一种有效治疗方法。