Bicket Mark C, Dunn Roger Y, Ahmed Shihab U
*Department of Anesthesiology and Critical Care Medicine, Johns Hopkins University School of Medicine, Baltimore, Maryland
Tufts University School of Medicine, Boston, Massachusetts.
Pain Med. 2016 Dec;17(12):2326-2336. doi: 10.1093/pm/pnw156. Epub 2016 Jul 21.
To assess the evidence base for high-frequency spinal cord stimulation (HFSCS). HFSCS has the potential to provide paresthesia-free pain relief for patients with chronic pain, in contrast to conventional spinal cord stimulation, which produces distracting and potentially unpleasant paresthesias.
A systematic review following standard methodological guidelines (Prospero #CRD42015029215).
We searched PubMed to March 14, 2016 without language restriction and hand-checked reference lists. Two authors independently performed study selection, bias evaluations, and data extraction. The pre-clinical review selected studies focusing on the mechanism and non-human experience with HFSCS. Clinically, any prospective study of adults using HFSCS (≥ 1000 Hz) was included.
Pre-clinical studies have characterized many aspects underlying the mechanism of HFSCS. For the clinical systematic review, eight trials (236 participants randomized or 160 followed prospectively) met inclusion criteria. All trials of HFSCS focused on patients with chronic low back pain with one exception, which included patients with chronic migraine. All but one trial documented funding by industry. Performance bias due to unmasked participants, physicians, and outcome assessors limited the quality of all but one study.
Significant growth in the preclinical and clinical evidence base for HFSCS suggests that HFSCS may differ from conventional SCS in mechanism of action and efficacy of treatment, respectively. Addressing current knowledge gaps in clinical evidence will require standardization in trial reporting and leveraging the paresthesia-free characteristic of HFSCS to enable masking in high-quality randomized controlled trials.
评估高频脊髓刺激（HFSCS）的证据基础。与传统脊髓刺激不同，传统脊髓刺激会产生令人分心且可能不适的感觉异常，而HFSCS有可能为慢性疼痛患者提供无感觉异常的疼痛缓解。
遵循标准方法学指南（Prospero #CRD42015029215）进行系统评价。
检索截至2016年3月14日的PubMed，无语言限制，并人工检查参考文献列表。两位作者独立进行研究选择、偏倚评估和数据提取。临床前综述选择关注HFSCS机制和非人类体验的研究。在临床上，纳入任何使用HFSCS（≥1000Hz）的成人前瞻性研究。
临床前研究已经阐明了HFSCS机制的许多方面。对于临床系统评价，八项试验（236名参与者随机分组或160名前瞻性随访）符合纳入标准。除一项试验外，所有HFSCS试验均聚焦于慢性下腰痛患者，该例外试验纳入了慢性偏头痛患者。除一项试验外，所有试验均记录有行业资助。由于参与者、医生和结果评估者未设盲导致的执行偏倚限制了除一项研究外所有研究的质量。
HFSCS临床前和临床证据基础的显著增长表明，HFSCS可能在作用机制和治疗效果方面与传统脊髓刺激有所不同。解决当前临床证据中的知识空白将需要试验报告的标准化，并利用HFSCS无感觉异常的特点，以便在高质量随机对照试验中实现设盲。
