Department of Anaesthesiology, Center for Pain Medicine, Erasmus MC University Medical Center, Rotterdam, The Netherlands; Department of Orthopaedics, Physiotherapy Unit, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
Department of Neurosurgery, Erasmus MC University Medical Center, Rotterdam, The Netherlands.
Pain Physician. 2020 Nov;23(6):553-564.
Cervical radicular pain (CRP) is a common problem in the adult population. When conservative treatment fails and the severe pain persist, surgical treatment is considered. However, surgery is associated with some serious risks. To reduce these risks, new minimally invasive techniques have been developed, such as percutaneous nucleoplasty. Several studies have shown that percutaneous nucleoplasty is a safe and effective technique for the treatment of CRP, but until now no randomized controlled trials have been conducted that compare percutaneous cervical nucleoplasty (PCN) to anterior cervical discectomy (ACD) in patients with a single-level contained soft-disc herniation.
To compare the effects of PCN and ACD in a group of patients with CRP caused by a single-level contained soft-disc herniation.
A randomized, controlled, multi-center trial.
Medical University Center and local hospitals.
Forty-eight patients with CRP as a result of a single-level contained soft-disc herniation were randomized to one of the following 2 treatments: PCN or ACD. The primary outcome measure was arm pain intensity, measured with a Visual Analog Scale (VAS). Secondary outcomes were arm pain intensity during heavy effort, neck pain, global perceived effect, Neck Disability Index (NDI), and the patients' general health (Short Form Generated Health Survey [SF-36]). All parameters were measured at baseline (T0), 3 months after intervention (T2), and one year after intervention (T3). One week after the intervention (T1), an intermediate assessment of arm pain, arm pain during heavy effort, neck pain, satisfaction, and improvement were performed.
At 3 months, the intention to treat analyses revealed a statistical significant interaction between the groups on the primary outcome, arm pain intensity, and on the secondary outcome of the SF-36 item pain, in favor of the ACD group. On the other secondary outcomes, no statistical significant differences were found between the groups over time. At 12 months, there was a trend for more improvement of arm pain in favor of the ACD group and no statistical interactions were found on the secondary outcomes.
Firstly, the inclusion by the participating hospitals was limited. Secondly, the trial was ended before reaching the required sample size. Thirdly, at baseline, after the inclusion by the neurosurgeon, 13 patients scored less than 50.0 mm on the VAS. Fourthly, the withdrawal of the physiotherapy (PT) group and finally, the patients and interventionists could not be blinded for the treatment.
At 3 months, the ACD group performed significantly better on arm pain reduction than the PCN group in patients with CRP as a result of a single-level contained soft-disc hernia. However, the clinical relevancy of this treatment effect can be debated. For all parameters, after one year, no significant differences between the groups were found. When it comes to the longer-term effectiveness, we conclude that PCN can be a good alternative for ACD.
颈椎神经根痛（CRP）是成年人中常见的问题。当保守治疗失败且疼痛持续严重时，会考虑手术治疗。然而，手术存在一些严重的风险。为了降低这些风险，已经开发了新的微创技术，如经皮髓核成形术。几项研究表明，经皮颈椎髓核成形术是治疗 CRP 的一种安全有效的技术，但迄今为止，尚无比较经皮颈椎髓核切除术（PCN）和前路颈椎间盘切除术（ACD）治疗单节段包容型椎间盘突出症患者的随机对照试验。
比较 PCN 和 ACD 在一组因单节段包容型椎间盘突出症引起的 CRP 患者中的效果。
一项随机、对照、多中心试验。
医科大学中心和当地医院。
将 48 例因单节段包容型椎间盘突出症引起的 CRP 患者随机分为以下 2 种治疗组之一：PCN 或 ACD。主要结局指标是手臂疼痛强度，采用视觉模拟量表（VAS）测量。次要结局指标为手臂重度用力时疼痛、颈部疼痛、总体感知效果、颈椎障碍指数（NDI）和患者一般健康状况（健康调查简表生成的健康状况 [SF-36]）。所有参数均在基线（T0）、干预后 3 个月（T2）和干预后 1 年（T3）进行测量。干预后 1 周（T1）进行手臂疼痛、手臂重度用力时疼痛、颈部疼痛、满意度和改善的中期评估。
在 3 个月时，意向治疗分析显示，在主要结局手臂疼痛强度和次要结局 SF-36 项目疼痛方面，组间存在统计学显著交互作用，有利于 ACD 组。在其他次要结局方面，各组在随访期间无统计学差异。在 12 个月时，手臂疼痛改善程度有利于 ACD 组，但无统计学交互作用。
首先，参与医院的纳入范围有限。其次，试验在达到所需样本量之前提前结束。第三，在基线时，神经外科医生纳入后，13 名患者的 VAS 评分低于 50.0 毫米。第四，物理治疗（PT）组退出，最后，患者和干预者无法对治疗进行盲法。
在 3 个月时，与 PCN 组相比，ACD 组在因单节段包容型椎间盘突出症引起的 CRP 患者中手臂疼痛减轻方面表现出显著更好的效果。然而，这种治疗效果的临床相关性值得商榷。对于所有参数，在 1 年后，两组之间没有发现显著差异。对于更长期的效果，我们的结论是 PCN 可以作为 ACD 的良好替代方案。
