International Science and Technology Cooperation Base of Spinal Cord Injury, Tianjin Key Laboratory of Spine and Spinal Cord Injury, Department of Orthopedics, Tianjin Medical University General Hospital, 154 Anshan Road, Heping District, Tianjin, 300052, China.
Eur Spine J. 2023 Jun;32(6):2029-2041. doi: 10.1007/s00586-023-07716-2. Epub 2023 Apr 17.
This study aims to evaluate the efficacy and safety of spinal cord stimulation (SCS) compared to conventional medical management (CMM) for patients diagnosed with chronic pain. Furthermore, the study seeks to compare the utilization of analgesics, as well as the long-term outcomes in terms of quality of life and functional capacity.
We systematically searched Cochrane Library, Web of Science, PubMed, and EMBASE for randomized controlled trials from inception up to February 2022.
Inclusion and exclusion criteria were set according to the PICOS criteria. We searched for studies in which SCS was compared with CMM alone for chronic pain. Two reviewers independently identified eligible studies and extracted data. Risk of bias assessments were performed according to Cochrane review criteria and Interventional Pain Management Techniques-quality Appraisal of Reliability and Risk of Bias Assessment (IPM-QRB) criteria.
The present meta-analysis comprised eight studies and included a total of 893 patients. Our findings demonstrate that spinal cord stimulation (SCS) in combination with conventional medical management (CMM) is associated with a significant reduction in visual analogue scale (VAS) pain intensity (P = 0.0005) and decreased scores on the McGill Pain Questionnaire (MPQ) (P < 0.0001). Moreover, SCS plus CMM was found to improve patients' quality of life, as evidenced by improvements in SF-36 scores (P < 0.00001), EQ-5D utility index (P = 0.008), and Oswestry Disability Index (ODI) (P < 0.00001). Based on the results of four high-quality randomized controlled trials (RCTs), the level of evidence supporting the efficacy of SCS for the treatment of painful neuropathy is graded as level I to II. In contrast, there is currently only low-level evidence to support the use of high-frequency stimulation and other chronic pain conditions, which can be attributed to a lack of sufficient randomized controlled trials.
The principal limitation of our study is the significant heterogeneity observed among the cohorts investigated. The primary source of this heterogeneity is the fact that spinal cord stimulation is indicated for the treatment of multiple chronic pain conditions. Moreover, variations in the stimulation parameters, differences among manufacturers, and the specific surgical implantation settings contribute to the increased heterogeneity observed in our analyses. To address this issue, we conducted a subgroup analysis based on specific situations and performed evidence synthesis to mitigate the potential impact of heterogeneity. These approaches allow for a more precise interpretation of the results and a more accurate evaluation of the quality of the included studies.
SCS is an effective treatment to relieve the pain level of chronic pain, decrease analgesic usage, and increase long-term quality of life and functional capacity.
本研究旨在评估脊髓刺激（SCS）与常规医学管理（CMM）相比，对慢性疼痛患者的疗效和安全性。此外，本研究还比较了两种治疗方法的镇痛药使用情况以及长期生活质量和功能能力的结果。
我们系统地检索了 Cochrane 图书馆、Web of Science、PubMed 和 EMBASE，以获取截至 2022 年 2 月的随机对照试验。
根据 PICOS 标准设定纳入和排除标准。我们搜索了将 SCS 与单独的 CMM 用于慢性疼痛的研究。两位审查员独立识别出合格的研究并提取数据。根据 Cochrane 审查标准和介入性疼痛管理技术可靠性和偏倚风险评估（IPM-QRB）标准进行偏倚风险评估。
本荟萃分析包括 8 项研究，共纳入 893 名患者。我们的研究结果表明，脊髓刺激（SCS）联合常规医学管理（CMM）可显著降低视觉模拟量表（VAS）疼痛强度（P=0.0005）和麦吉尔疼痛问卷（MPQ）评分（P<0.0001）。此外，SCS 联合 CMM 可改善患者的生活质量，SF-36 评分（P<0.00001）、EQ-5D 效用指数（P=0.008）和 Oswestry 残疾指数（ODI）（P<0.00001）均有改善。基于四项高质量随机对照试验（RCT）的结果，支持 SCS 治疗疼痛性神经病疗效的证据水平评为 I 级至 II 级。相比之下，目前仅低水平证据支持高频刺激和其他慢性疼痛疾病的应用，这归因于缺乏足够的随机对照试验。
本研究的主要局限性在于所研究队列中观察到的显著异质性。这种异质性的主要来源是脊髓刺激被用于治疗多种慢性疼痛疾病。此外，刺激参数的差异、制造商之间的差异以及特定的手术植入设置导致了我们分析中观察到的异质性增加。为了解决这个问题，我们根据具体情况进行了亚组分析，并进行了证据综合，以减轻潜在的异质性影响。这些方法可以更准确地解释结果，并更准确地评估纳入研究的质量。
SCS 是一种有效的治疗方法，可缓解慢性疼痛的疼痛程度、减少镇痛药的使用，并提高长期生活质量和功能能力。
