Institute for Musculoskeletal Health, The University of Sydney and Sydney Local Health District, Sydney, Australia.
School of Public Health, Faculty of Medicine and Health, The University of Sydney, Sydney, Australia.
Cochrane Database Syst Rev. 2023 Mar 7;3(3):CD014789. doi: 10.1002/14651858.CD014789.pub2.
Spinal cord stimulation (SCS) is a surgical intervention used to treat persistent low back pain. SCS is thought to modulate pain by sending electrical signals via implanted electrodes into the spinal cord. The long term benefits and harms of SCS for people with low back pain are uncertain.
To assess the effects, including benefits and harms, of SCS for people with low back pain.
On 10 June 2022, we searched CENTRAL, MEDLINE, Embase, and one other database for published trials. We also searched three clinical trials registers for ongoing trials.
We included all randomised controlled trials and cross-over trials comparing SCS with placebo or no treatment for low back pain. The primary comparison was SCS versus placebo, at the longest time point measured in the trials. Major outcomes were mean low back pain intensity, function, health-related quality of life, global assessment of efficacy, withdrawals due to adverse events, adverse events, and serious adverse events. Our primary time point was long-term follow-up (≥ 12 months).
We used standard methodological procedures expected by Cochrane.
We included 13 studies with 699 participants: 55% of participants were female; mean age ranged from 47 to 59 years; and all participants had chronic low back pain with mean duration of symptoms ranging from five to 12 years. Ten cross-over trials compared SCS with placebo. Three parallel-group trials assessed the addition of SCS to medical management. Most studies were at risk of performance and detection bias from inadequate blinding and selective reporting bias. The placebo-controlled trials had other important biases, including lack of accounting for period and carryover effects. Two of the three parallel trials assessing SCS as an addition to medical management were at risk of attrition bias, and all three had substantial cross-over to the SCS group for time points beyond six months. In the parallel-group trials, we considered the lack of placebo control to be an important source of bias. None of our included studies evaluated the impact of SCS on mean low back pain intensity in the long term (≥ 12 months). The studies most often assessed outcomes in the immediate term (less than one month). At six months, the only available evidence was from a single cross-over trial (50 participants). There was moderate-certainty evidence that SCS probably does not improve back or leg pain, function, or quality of life compared with placebo. Pain was 61 points (on a 0- to 100-point scale, 0 = no pain) at six months with placebo, and 4 points better (8.2 points better to 0.2 points worse) with SCS. Function was 35.4 points (on a 0- to 100-point scale, 0 = no disability or best function) at six months with placebo, and 1.3 points better (3.9 points better to 1.3 points worse) with SCS. Health-related quality of life was 0.44 points out of 1 (0 to 1 index, 0 = worst quality of life) at six months with placebo, and 0.04 points better (0.16 points better to 0.08 points worse) with SCS. In that same study, nine participants (18%) experienced adverse events and four (8%) required revision surgery. Serious adverse events with SCS included infections, neurological damage, and lead migration requiring repeated surgery. We could not provide effect estimates of the relative risks as events were not reported for the placebo period. In parallel trials assessing SCS as an addition to medical management, it is uncertain whether, in the medium or long term, SCS can reduce low back pain, leg pain, or health-related quality of life, or if it increases the number of people reporting a 50% improvement or better, because the certainty of the evidence was very low. Low-certainty evidence suggests that adding SCS to medical management may slightly improve function and slightly reduce opioid use. In the medium term, mean function (0- to 100-point scale; lower is better) was 16.2 points better with the addition of SCS to medical management compared with medical management alone (95% confidence interval (CI) 19.4 points better to 13.0 points better; I = 95%; 3 studies, 430 participants; low-certainty evidence). The number of participants reporting opioid medicine use was 15% lower with the addition of SCS to medical management (95% CI 27% lower to 0% lower; I = 0%; 2 studies, 290 participants; low-certainty evidence). Adverse events with SCS were poorly reported but included infection and lead migration. One study found that, at 24 months, 13 of 42 people (31%) receiving SCS required revision surgery. It is uncertain to what extent the addition of SCS to medical management increases the risk of withdrawals due to adverse events, adverse events, or serious adverse events, because the certainty of the evidence was very low.
AUTHORS' CONCLUSIONS: Data in this review do not support the use of SCS to manage low back pain outside a clinical trial. Current evidence suggests SCS probably does not have sustained clinical benefits that would outweigh the costs and risks of this surgical intervention.
脊髓刺激 (SCS) 是一种用于治疗持续性腰痛的手术干预措施。SCS 通过将电信号经植入的电极发送到脊髓来调节疼痛。SCS 对腰痛患者的长期益处和危害尚不确定。
评估 SCS 对腰痛患者的疗效，包括获益和危害。
2022 年 6 月 10 日，我们检索了 CENTRAL、MEDLINE、Embase 和另外一个数据库中发表的试验。我们还检索了三个临床试验注册库以查找正在进行的试验。
我们纳入了所有比较 SCS 与安慰剂或不治疗腰痛的随机对照试验和交叉试验。主要比较是 SCS 与安慰剂在试验中最长时间点的比较。主要结局是腰痛平均强度、功能、健康相关生活质量、总体疗效评估、因不良事件退出、不良事件和严重不良事件。我们的主要随访时间点为长期随访（≥ 12 个月）。
我们使用了 Cochrane 预期的标准方法学程序。
我们纳入了 13 项研究，共 699 名参与者：55%的参与者为女性；平均年龄为 47 至 59 岁；所有参与者均患有慢性腰痛，症状持续时间平均为 5 至 12 年。10 项交叉试验比较了 SCS 与安慰剂。3 项平行组试验评估了 SCS 加药物治疗的效果。大多数研究存在因未充分设盲和选择性报告偏倚而导致的偏倚风险，以及因失访导致的效能偏倚。安慰剂对照试验还存在其他重要偏倚，包括未考虑周期和交叉效应。评估 SCS 作为药物治疗附加手段的 3 项平行试验中的 2 项存在失访偏倚，所有 3 项试验在 6 个月后均有大量交叉到 SCS 组。在平行组试验中，我们认为缺乏安慰剂对照是一个重要的偏倚来源。我们纳入的研究均未评估 SCS 对腰痛长期（≥ 12 个月）平均强度的影响。研究最常评估短期（少于 1 个月）的结局。在 6 个月时，唯一可用的证据来自一项单交叉试验（50 名参与者）。有中等确定性证据表明，与安慰剂相比，SCS 可能并不能改善腰痛、腿痛、功能或生活质量。在 6 个月时，安慰剂组的疼痛为 61 分（0-100 分，0 分表示无痛），SCS 组疼痛改善 4 分（8.2 分改善至 0.2 分恶化）。在 6 个月时，安慰剂组的功能为 35.4 分（0-100 分，0 分表示无残疾或最佳功能），SCS 组的功能改善 1.3 分（3.9 分改善至 1.3 分恶化）。在 6 个月时，安慰剂组的健康相关生活质量为 0.44 分（0 分表示最差的生活质量，0 分至 1 分指数，0 分表示最差的生活质量），SCS 组的健康相关生活质量改善 0.04 分（0.16 分改善至 0.08 分恶化）。在同一项研究中，有 9 名参与者（18%）发生不良事件，4 名（8%）需要进行翻修手术。SCS 的严重不良事件包括感染、神经损伤和需要反复手术的导线迁移。我们无法提供相对风险的效应估计值，因为未报告安慰剂期的事件。在评估 SCS 作为药物治疗附加手段的平行试验中，尚不确定在中、长期内，SCS 是否可以减轻腰痛、腿痛或健康相关生活质量，或是否可以增加报告 50%以上改善的人数，因为证据的确定性非常低。低确定性证据表明，在中、长期内，添加 SCS 可能略微改善功能并略微减少阿片类药物的使用。在中期，与单纯药物治疗相比，添加 SCS 到药物治疗中可使功能平均改善 16.2 分（95%置信区间为 19.4 分改善至 13.0 分改善；I = 95%；3 项研究，430 名参与者；低确定性证据）。添加 SCS 到药物治疗中可使报告使用阿片类药物的参与者人数减少 15%（95%置信区间为 27%减少至 0%减少；I = 0%；2 项研究，290 名参与者；低确定性证据）。SCS 的不良事件报告不佳，但包括感染和导线迁移。一项研究发现，在 24 个月时，42 名接受 SCS 的人中，有 13 人（31%）需要进行翻修手术。尚不确定添加 SCS 到药物治疗中会增加因不良事件、不良事件或严重不良事件而退出的风险程度，因为证据的确定性非常低。
在临床试验之外，SCS 对腰痛的管理没有效果。目前的证据表明，SCS 可能不会带来持续的临床获益，其获益可能不会超过这种手术干预的风险和成本。
