Sorrell Robert Gordon, Muhlenfeld Jamie, Moffett John, Stevens Gary, Kesten Steven
Alabama Orthopedic Center, Birmingham, AL, USA.
Regenesis Biomedical Inc., Scottsdale, AZ, USA.
J Pain Res. 2018 Jun 22;11:1209-1222. doi: 10.2147/JPR.S164303. eCollection 2018.
BACKGROUND: The incidence of chronic postoperative pain following lumbar spinal surgery has increased with the overall increase in the prevalence of lumbar surgery. This study was conducted to evaluate the analgesic effectiveness of pulsed electromagnetic field (PEMF) therapy in subjects with persistent pain following lumbar surgery. PATIENTS AND METHODS: A randomized, double-blind, sham-controlled, multicenter study in 36 subjects with persistent low-back and/or radiating leg pain after lumbar surgery was conducted. Eligible subjects were randomized (1:1:1) to receive one of two doses of therapy (42-μs or 38-μs pulse width) or treatment with a sham device. Subjects self-treated twice daily for 60 days. The primary end point was change in pain intensity (∆PI) using the Numerical Pain Rating Scale between average baseline (Days -5 to -1) and end of treatment (Days 56-60) for lumbar and radiating leg pain. Secondary outcome measures included the Oswestry Disability Index, Beck Depression Inventory-II, Patient Global Impression of Change, and consumption of analgesics. RESULTS: Low-back pain scores for the 42-μs group decreased by 40.2% ( = 0.028), compared to 18.6% for the 38-μs pulse width group ( = 0.037) and 25.6% for the sham group ( = 0.013 per protocol population). Average leg pain scores decreased by 45.0% (42 μs, = 0.009), 17.0% (38 μs, = 0.293), and 24.5% (sham, = 0.065). The proportion of subjects responding to therapy, time to 30% reduction in pain scores, and Patient Global Impression of Change were improved with the PEMF 42-μs device over the sham control, although results were associated with -values >0.05. CONCLUSION: PEMF therapy (42-μs pulse width) was associated with trends for a reduction in pain, compared to sham treatment. Secondary endpoints were consistent with an overall beneficial effect of the PEMF 42-μs pulse width device.
背景:随着腰椎手术总体患病率的上升,腰椎手术后慢性疼痛的发生率也有所增加。本研究旨在评估脉冲电磁场(PEMF)疗法对腰椎手术后持续疼痛患者的镇痛效果。 患者与方法:对36例腰椎手术后持续存在腰背部和/或腿部放射性疼痛的患者进行了一项随机、双盲、假对照、多中心研究。符合条件的受试者被随机分配(1:1:1)接受两种剂量疗法之一(脉冲宽度为42微秒或38微秒)或使用假装置进行治疗。受试者每天自行治疗两次,持续60天。主要终点是使用数字疼痛评分量表评估腰椎和腿部放射性疼痛在平均基线(第-5天至-1天)和治疗结束(第56 - 60天)之间的疼痛强度变化(∆PI)。次要结局指标包括奥斯威斯利残疾指数、贝克抑郁量表第二版、患者整体变化印象以及镇痛药的消耗量。 结果:42微秒组的腰背痛评分下降了40.2%(P = 0.028),相比之下,38微秒脉冲宽度组下降了18.6%(P = 0.037),假治疗组下降了25.6%(按方案人群P = 0.013)。腿部平均疼痛评分下降了45.0%(42微秒,P = 0.009)、17.0%(38微秒,P = 0.293)和24.5%(假治疗组,P = 0.065)。与假对照相比,使用42微秒PEMF装置治疗的受试者对治疗有反应的比例、疼痛评分降低30%的时间以及患者整体变化印象均有所改善,尽管结果的P值>0.05。 结论:与假治疗相比,PEMF疗法(42微秒脉冲宽度)有疼痛减轻的趋势。次要终点与42微秒脉冲宽度PEMF装置的总体有益效果一致。
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