Pain. 2021 Jul 1;162(7):1935-1956. doi: 10.1097/j.pain.0000000000002204.
Spinal cord stimulation (SCS) is an interventional nonpharmacologic treatment used for chronic pain and other indications. Methods for evaluating the safety and efficacy of SCS have evolved from uncontrolled and retrospective studies to prospective randomized controlled trials (RCTs). Although randomization overcomes certain types of bias, additional challenges to the validity of RCTs of SCS include blinding, choice of control groups, nonspecific effects of treatment variables (eg, paresthesia, device programming and recharging, psychological support, and rehabilitative techniques), and safety considerations. To address these challenges, 3 professional societies (Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials, Institute of Neuromodulation, and International Neuromodulation Society) convened a meeting to develop consensus recommendations on the design, conduct, analysis, and interpretation of RCTs of SCS for chronic pain. This article summarizes the results of this meeting. Highlights of our recommendations include disclosing all funding source and potential conflicts; incorporating mechanistic objectives when possible; avoiding noninferiority designs without internal demonstration of assay sensitivity; achieving and documenting double-blinding whenever possible; documenting investigator and site experience; keeping all information provided to patients balanced with respect to expectation of benefit; disclosing all information provided to patients, including verbal scripts; using placebo/sham controls when possible; capturing a complete set of outcome assessments; accounting for ancillary pharmacologic and nonpharmacologic treatments in a clear manner; providing a complete description of intended and actual programming interactions; making a prospective ascertainment of SCS-specific safety outcomes; training patients and researchers on appropriate expectations, outcome assessments, and other key aspects of study performance; and providing transparent and complete reporting of results according to applicable reporting guidelines.
脊髓刺激 (SCS) 是一种用于慢性疼痛和其他适应症的介入性非药物治疗方法。SCS 的安全性和疗效评估方法已经从非对照和回顾性研究发展到前瞻性随机对照试验 (RCT)。虽然随机化克服了某些类型的偏倚，但 SCS 的 RCT 有效性还面临其他挑战，包括盲法、对照组的选择、治疗变量的非特异性效应（例如，感觉异常、设备编程和充电、心理支持和康复技术）以及安全性考虑。为了解决这些挑战，3 个专业协会（临床试验中的方法、测量和疼痛评估倡议、神经调节学会和国际神经调节学会）召开了一次会议，就 SCS 治疗慢性疼痛的 RCT 的设计、实施、分析和解释制定共识建议。本文总结了这次会议的结果。我们建议的要点包括：披露所有资金来源和潜在利益冲突；尽可能纳入机制目标；在没有内部证明检测灵敏度的情况下避免非劣效性设计；尽可能实现并记录双盲；记录研究者和研究地点的经验；保持向患者提供的所有信息在受益预期方面保持平衡；披露向患者提供的所有信息，包括口头脚本；尽可能使用安慰剂/假对照；收集完整的结果评估；以清晰的方式说明辅助药物和非药物治疗；对预期和实际编程交互作用进行前瞻性确定；对 SCS 特定的安全性结果进行前瞻性评估；对患者和研究人员进行适当的期望、结果评估和研究表现的其他关键方面的培训；并根据适用的报告指南透明、完整地报告结果。
