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一项关于脉冲电磁场疗法治疗腰椎手术失败综合征疼痛的开放标签试验性研究。

An open-label pilot study of pulsed electromagnetic field therapy in the treatment of failed back surgery syndrome pain.

作者信息

Harper Wayne L, Schmidt William K, Kubat Nicole J, Isenberg Richard A

机构信息

Tarheel Clinical Research, LLC, Raleigh, NC, USA.

NorthStar Consulting, LLC, Davis, CA, USA.

出版信息

Int Med Case Rep J. 2014 Dec 31;8:13-22. doi: 10.2147/IMCRJ.S73068. eCollection 2015.


DOI:10.2147/IMCRJ.S73068
PMID:25678825
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC4317147/
Abstract

Persistent pain following back surgery remains a major treatment challenge. The primary objective of this open-label exploratory study was to investigate the analgesic effectiveness of pulsed electromagnetic field therapy administered twice daily over a 45-day period in 34 subjects (68% female) with persistent or recurrent pain following back surgery. A secondary goal was to guide the design of future randomized controlled trials that could target responsive subpopulations. All predefined primary and secondary outcomes, including change in pain intensity (PI), physical function (Oswestry Disability Index), analgesic consumption, and overall well-being (Patient Global Impression of Change), are reported. A responder analysis (≥30% reduction in PI versus baseline) was added as a post hoc evaluation. Safety outcomes, as well as results of a cost-avoidance survey, are also summarized. Of the 30 per-protocol subjects who completed the study, 33% reported a clinically meaningful (≥30%) reduction in PI. A higher response rate (60%) was reported for subjects who had undergone discectomy prior to the trial compared to subjects who had undergone other types of surgical interventions (decompression or fusion) without discectomy. Improvements in PI were paralleled by improvements in secondary outcomes. Relative to baseline, responders reported an average 44% and 55% reduction in back PI and leg PI (respectively), and an average 13% improvement in Oswestry Disability Index scores. In the per-protocol population, 50% of responders and 12% of nonresponders reported less analgesia consumption at the end of treatment versus baseline. Sixty-seven percent of per-protocol responders and 0% of nonresponders reported clinically meaningful improvement in overall well-being on the Patient Global Impression of Change scale.

摘要

脊柱手术后的持续性疼痛仍然是一个重大的治疗挑战。这项开放标签探索性研究的主要目的是调查在34名(68%为女性)脊柱手术后出现持续性或复发性疼痛的受试者中,每日两次给予脉冲电磁场疗法,为期45天的镇痛效果。次要目标是为未来针对有反应的亚群的随机对照试验设计提供指导。报告了所有预先定义的主要和次要结果,包括疼痛强度(PI)变化、身体功能(Oswestry功能障碍指数)、镇痛药物消耗和总体幸福感(患者总体改善印象)。作为事后评估增加了反应者分析(PI相对于基线降低≥30%)。还总结了安全性结果以及成本规避调查结果。在完成研究的30名符合方案受试者中,33%报告PI有临床意义的(≥30%)降低。与未进行椎间盘切除术而接受其他类型手术干预(减压或融合)的受试者相比,在试验前接受过椎间盘切除术的受试者报告的反应率更高(60%)。PI的改善与次要结果的改善并行。相对于基线,反应者报告背部PI和腿部PI平均分别降低44%和55%,Oswestry功能障碍指数评分平均提高13%。在符合方案人群中,50%的反应者和12%的无反应者报告在治疗结束时与基线相比镇痛药物消耗减少。67%的符合方案反应者和0%的无反应者在患者总体改善印象量表上报告总体幸福感有临床意义的改善。

https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab0f/4317147/5450ae275bca/imcrj-8-013Fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab0f/4317147/0776aaeb1d14/imcrj-8-013Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab0f/4317147/5ab29041cd75/imcrj-8-013Fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab0f/4317147/5450ae275bca/imcrj-8-013Fig3.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab0f/4317147/0776aaeb1d14/imcrj-8-013Fig1.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab0f/4317147/5ab29041cd75/imcrj-8-013Fig2.jpg
https://cdn.ncbi.nlm.nih.gov/pmc/blobs/ab0f/4317147/5450ae275bca/imcrj-8-013Fig3.jpg

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本文引用的文献

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