Chronic low back pain can be caused by impaired control and degeneration of the multifidus muscles and consequent functional instability of the lumbar spine. Available treatment options have limited effectiveness and prognosis is unfavorable. We conducted an international randomized, double-blind, sham-controlled trial at 26 multidisciplinary centers to determine safety and efficacy of an implantable, restorative neurostimulator designed to restore multifidus neuromuscular control and facilitate relief of symptoms (clinicaltrials.gov identifier: NCT02577354). Two hundred four eligible participants with refractory mechanical (musculoskeletal) chronic LBP and a positive prone instability test indicating impaired multifidus control were implanted and randomized to therapeutic (N = 102) or low-level sham (N = 102) stimulation of the medial branch of the dorsal ramus nerve (multifidus nerve supply) for 30 minutes twice daily. The primary endpoint was the comparison of responder proportions (≥30% relief on the LBP visual analogue scale without analgesics increase) at 120 days. After the primary endpoint assessment, participants in the sham-control group switched to therapeutic stimulation and the combined cohort was assessed through 1 year for long-term outcomes and adverse events. The primary endpoint was inconclusive in terms of treatment superiority (57.1% vs 46.6%; difference: 10.4%; 95% confidence interval, -3.3% to 24.1%, P = 0.138). Prespecified secondary outcomes and analyses were consistent with a modest but clinically meaningful treatment benefit at 120 days. Improvements from baseline, which continued to accrue in all outcome measures after conclusion of the double-blind phase, were clinically important at 1 year. The incidence of serious procedure- or device-related adverse events (3.9%) compared favorably with other neuromodulation therapies for chronic pain.

中文翻译：

---

用于难治性机械性慢性腰痛的植入式恢复性神经刺激器：一项随机假手术对照临床试验。

慢性腰痛可能是由多裂肌控制受损和退化以及随之而来的腰椎功能不稳定引起的。现有的治疗方案效果有限，预后不良。我们在 26 个多学科中心进行了一项国际随机、双盲、假对照试验，以确定旨在恢复多裂肌神经肌肉控制并促进症状缓解的植入式恢复性神经刺激器的安全性和有效性（clinicaltrials.gov 标识符：NCT02577354）。204 名患有难治性机械（肌肉骨骼）慢性 LBP 且倾向不稳定测试呈阳性（表明多裂肌控制受损）的合格参与者被植入并随机接受治疗性（N = 102）或低水平假手术（N = 102）刺激内侧支背支神经（多裂神经支配）每天两次，每次 30 分钟。主要终点是 120 天时反应者比例的比较（LBP 视觉模拟量表缓解≥30%，不增加镇痛药）。主要终点评估后，假对照组的参与者转而接受治疗刺激，并对联合队列进行为期 1 年的长期结果和不良事件评估。主要终点在治疗优势方面尚无结论（57.1% vs 46.6%；差异：10.4%；95% 置信区间，-3.3% 至 24.1%，P = 0.138）。预先设定的次要结局和分析与 120 天时适度但具有临床意义的治疗益处一致。在双盲阶段结束后，所有结果指标均继续取得与基线相比的改善，这一改善在一年时具有临床意义。与其他治疗慢性疼痛的神经调节疗法相比，严重的手术或设备相关不良事件的发生率 (3.9%) 较低。