最近的一个abc 4角事件质疑手术植入的脊髓刺激器治疗慢性背痛。 adrian traegar博士和合著者调查了证据基础。 在美国广播公司本周播出的《四个角落》节目中，人们对使用脊髓刺激器治疗慢性背痛提出了质疑。 脊髓刺激器是通过手术植入的设备，可以将电脉冲直接传递到脊髓。 自20世纪60年代以来，它们一直被用于治疗慢性疼痛患者。 随着时间的推移，它们的设计发生了重大变化。 早期的模型需要外部发生器和侵入性手术来植入。 目前的设备是完全可植入的，可充电的，可以传递各种电信号。 然而，尽管它们有着悠久的历史，但本世纪才进行了严格的实验研究来测试脊髓刺激器的有效性。 这些发现不支持它们用于治疗慢性疼痛。 事实上，数据表明存在很大的伤害风险。 证据说明了什么？第一批用于支持脊髓刺激器有效性的研究发表于2005年。 这项研究观察了那些从最初的脊柱手术中没有得到缓解的患者，并将植入脊髓刺激器与重复脊柱手术进行了比较。 尽管它发现脊髓刺激是治疗慢性背痛更有效的干预措施，但这项研究将该设备与曾经失败过的设备进行了比较，这是一个明显的局限。 后来的研究提供了更有用的证据。 他们将脊髓刺激与非手术治疗或安慰剂设备（例如停用的脊髓刺激器）进行了比较。 一份2023年cochrane对已发表的比较研究的综述发现，几乎所有的研究都局限于短期结果（周）。 虽然一些研究显示，主动刺激脊髓可以更好地缓解疼痛，但其益处很小，证据也不确定。 只有一项高质量的研究将脊髓刺激与安慰剂进行了长达六个月的比较，结果显示没有任何益处。 这篇综述的结论是，这些数据不支持对背痛患者使用脊髓刺激。 那么危害呢？实验研究的参与者往往很少，因此很难估计脊髓刺激的危害。 所以我们需要寻找其他来源。 对澳大利亚治疗用品管理局报告的不良事件的审查发现，其危害可能很严重。 在2012年至2019年间报告的520起事件中，79%被认为是“严重”事件，13%是“危及生命”事件。 我们不知道在这段时间里到底植入了多少脊髓刺激器，但这种手术在澳大利亚进行得相当广泛，尤其是在私营部门和工人补偿部门。 2023年，健康保险数据显示，全国各地进行了1300多次脊髓刺激器手术。 在这项审查中，大约一半的报告伤害是由于设备本身的故障（例如，电线断裂，或导线移动到身体的错误位置）。 另一半患者的健康状况下降，如不明原因的疼痛、感染和脊髓周围撕裂。 超过80%的伤害需要至少一次手术来纠正问题。 同一项研究报告称，每10个植入的脊髓刺激器中就有4个被移除。 高昂的成本这里的成本相当可观，仅设备就要花费数万美元。 加上相关的医院和医疗费用，单次手术的总费用平均超过50000美元。 由于许多患者要接受多次重复手术，以数十万美元为单位的费用并不罕见。 医疗保险、私人医疗基金和其他保险计划的回扣可能会与自付捐款一起用于这一总额。 保险公司不确定脊髓刺激器的有效性，但由于它们的植入被列在医疗保险福利表上，而且这些设备被政府批准报销，保险公司被迫为其使用提供资金。 行业影响如果有证据表明与安慰剂相比没有持续的益处，危害很大，成本很高，为什么脊髓刺激器在澳大利亚如此普遍地使用？例如，在新西兰，这种设备很少使用。 在澳大利亚植入脊髓刺激器的医生报酬丰厚，新西兰的资金安排也有所不同。 但新西兰缺乏使用的主要原因是那里的疼痛专家不相信它们的有效性。 在澳大利亚和其他地方，植入脊髓刺激器的疼痛专家和设备制造商经常一致大力推广脊髓刺激剂的使用。 脊髓刺激装置行业保护利润的策略与烟草行业的策略进行了比较。 2023年的一篇论文描述了这些策略，其中包括用工业资助的研究淹没科学文献，破坏不利的独立研究，以及攻击那些对这些设备提出担忧的人的可信度。 这并不全是坏消息，许多慢性疼痛患者在看完《四角报》的报道后可能会感到幻灭。 但也不全是坏消息。 澳大利亚恰好是一些世界顶级背痛研究人员的家园，他们正在研究安全有效的治疗方法。 新的方法，如感觉运动再训练，包括保证和鼓励提高患者的活动水平，针对与疼痛相关的无益思维和行为的认知功能疗法，以及锻炼等旧方法，最近在强有力的临床研究中显示出了益处。 如果我们要取消对昂贵、有害和无效治疗的资助，更多的资金可以用于有效的治疗。 这篇文章最初发表在对话中，因为有证据不支持脊髓刺激器治疗慢性背痛，而且它们可能会造成伤害。作者是悉尼大学医学与健康学院肌肉骨骼健康研究所的adrian traeger和caitlin jones，以及悉尼大学的ian harris教授。 这篇文章最初发表在对话中，因为有证据不支持脊髓刺激器治疗慢性背痛，而且它们可能会造成伤害。作者是悉尼大学医学与健康学院肌肉骨骼健康研究所的adrian traeger和caitlin jones，以及悉尼大学的ian harris教授。
a recent abc 4 corners episode questioned the use of surgically implanted devices called spinal cord stimulators for chronic back pain. dr adrian traegar and co-authors investigate the evidence base.in an episode of abc’s four corners this week, the use of spinal cord stimulators for chronic back pain was brought into question.spinal cord stimulators are devices implanted surgically which deliver electric impulses directly to the spinal cord. they’ve been used to treat people with chronic pain since the 1960s.their design has changed significantly over time. early models required an external generator and invasive surgery to implant them. current devices are fully implantable, rechargeable and can deliver a variety of electrical signals.however, despite their long history, rigorous experimental research to test the effectiveness of spinal cord stimulators has only been conducted this century. the findings don’t support their use for treating chronic pain. in fact, data points to a significant risk of harm.what does the evidence say?one of the first studies used to support the effectiveness of spinal cord stimulators was published in 2005. this study looked at patients who didn’t get relief from initial spinal surgery and compared implantation of a spinal cord stimulator to a repeat of the spinal surgery.although it found spinal cord stimulation was the more effective intervention for chronic back pain, the fact this study compared the device to something that had already failed once is an obvious limitation.later studies provided more useful evidence. they compared spinal cord stimulation to non-surgical treatments or placebo devices (for example, deactivated spinal cord stimulators).a 2023 cochrane review of the published comparative studies found nearly all studies were restricted to short-term outcomes (weeks). and while some studies appeared to show better pain relief with active spinal cord stimulation, the benefits were small, and the evidence was uncertain.only one high-quality study compared spinal cord stimulation to placebo up to six months, and it showed no benefit. the review concluded the data doesn’t support the use of spinal cord stimulation for people with back pain.what about the harms?the experimental studies often had small numbers of participants, making any estimate of the harms of spinal cord stimulation difficult. so we need to look to other sources.a review of adverse events reported to australia’s therapeutic goods administration found the harms can be serious. of the 520 events reported between 2012 and 2019, 79% were considered “severe” and 13% were “life threatening”.we don’t know exactly how many spinal cord stimulators were implanted during this period, however this surgery is done reasonably widely in australia, particularly in the private and workers compensation sectors. in 2023, health insurance data showed more than 1,300 spinal cord stimulator procedures were carried out around the country.in the review, around half the reported harms were due to a malfunction of the device itself (for example, fracture of the electrical lead, or the lead moved to the wrong spot in the body). the other half involved declines in people’s health such as unexplained increased pain, infection, and tears in the lining around the spinal cord.more than 80% of the harms required at least one surgery to correct the problem. the same study reported four out of every ten spinal cord stimulators implanted were being removed.high coststhe cost here is considerable, with the devices alone costing tens of thousands of dollars. adding associated hospital and medical costs, the total cost for a single procedure averages more than $a50,000. with many patients undergoing multiple repeat procedures, it’s not unusual for costs to be measured in hundreds of thousands of dollars.rebates from medicare, private health funds and other insurance schemes may go towards this total, along with out-of-pocket contributions.insurers are uncertain of the effectiveness of spinal cord stimulators, but because their implantation is listed on the medicare benefits schedule and the devices are approved for reimbursement by the government, insurers are forced to fund their use.industry influenceif the evidence suggests no sustained benefit over placebo, the harms are significant and the cost is high, why are spinal cord stimulators being used so commonly in australia? in new zealand, for example, the devices are rarely used.doctors who implant spinal cord stimulators in australia are well remunerated and funding arrangements are different in new zealand. but the main reason behind the lack of use in new zealand is because pain specialists there are not convinced of their effectiveness.in australia and elsewhere, the use of spinal cord stimulators is heavily promoted by the pain specialists who implant them, and the device manufacturers, often in unison. the tactics used by the spinal cord stimulator device industry to protect profits have been compared to tactics used by the tobacco industry.a 2023 paper describes these tactics which include flooding the scientific literature with industry-funded research, undermining unfavourable independent research, and attacking the credibility of those who raise concerns about the devices.it’s not all bad newsmany who suffer from chronic pain may feel disillusioned after watching the four corners report. but it’s not all bad news. australia happens to be home to some of the world’s top back pain researchers who are working on safe, effective therapies.new approaches such as sensorimotor retraining, which includes reassurance and encouragement to increase patients’ activity levels, cognitive functional therapy, which targets unhelpful pain-related thinking and behaviour, and old approaches such as exercise, have recently shown benefits in robust clinical research.if we were to remove funding for expensive, harmful and ineffective treatments, more funding could be directed towards effective ones.this article was originally published in the conversation as evidence doesn’t support spinal cord stimulators for chronic back pain – and they could cause harm , written by dr adrian traeger and dr caitlin jones from the institute of musculoskeletal health, faculty of medicine and health, university of sydney and professor ian harris, unsw sydney. .
