Estores Irene, Chen Kevin, Jackson Brian, Lao Lixing, Gorman Peter H
a University of Florida Health Integrative Medicine Program , Gaineseville , FL , USA.
b Center for Integrative Medicine , University of Maryland School of Medicine , Baltimore , MD , USA.
J Spinal Cord Med. 2017 Jul;40(4):432-438. doi: 10.1080/10790268.2016.1141489. Epub 2016 Feb 15.
To obtain preliminary data on the effects of an auricular acupuncture protocol, Battlefield Acupuncture (BFA), on self-reported pain intensity in persons with chronic Spinal Cord Injury (SCI) and neuropathic pain.
Pilot randomized delayed entry single center crossover clinical trial at an outpatient rehabilitation and integrative medicine hospital center.
Chronic (> one year post injury) ASIA impairment scale A through D individuals with SCI with injury level from C3 through T12 and below level neuropathic pain with at least five on the Numeric Rating Scale (NRS) were recruited. Twenty-four subjects were randomized to either an eight-week once weekly ten-needle BFA protocol (n = 13) or to a waiting list followed by the BFA protocol (n = 11).
The primary outcome measure was change in the pain severity NRS. Secondary outcome was the Global Impression of Change.
Demographically there were no significant differences between groups. Mean pain scores at baseline were higher in acupuncture than control subjects (7.75 ± 1.54 vs. 6.25 ± 1.04, P = 0.027). Although both groups reported significant reduction in pain during the trial period, the BFA group reported more pain reduction than the delayed entry group (average change in NRS at eight weeks -2.92 ± 2.11 vs. -1.13 ± 2.14, P = 0.065). There was a significant difference in groups when a group-by-time interaction in a mixed-effect repeated measures model (P = 0.014).
This pilot study has provided proof of concept that BFA has clinically meaningful effect on the modulation of SCI neuropathic pain.
获取关于耳针疗法——战场针刺疗法（BFA）对慢性脊髓损伤（SCI）患者自述疼痛强度及神经性疼痛影响的初步数据。
在一家门诊康复与综合医学医院中心进行的试点随机延迟入组单中心交叉临床试验。
招募慢性（损伤后一年以上）美国脊髓损伤协会（ASIA）损伤分级为A至D级、损伤平面从C3至T12且存在损伤平面以下神经性疼痛、数字评定量表（NRS）评分至少为5分的SCI患者。24名受试者被随机分为两组，一组接受为期八周、每周一次的十针BFA方案（n = 13），另一组先进入等待名单，之后接受BFA方案（n = 11）。
主要观察指标为疼痛严重程度NRS的变化。次要观察指标为总体变化印象。
在人口统计学方面，两组之间无显著差异。针刺组的基线平均疼痛评分高于对照组（7.75 ± 1.54 vs. 6.25 ± 1.04，P = 0.027）。尽管两组在试验期间均报告疼痛显著减轻，但BFA组报告的疼痛减轻程度高于延迟入组组（八周时NRS的平均变化为-2.92 ± 2.11 vs. -1.13 ± 2.14，P = 0.065）。在混合效应重复测量模型中进行组间时间交互分析时，两组存在显著差异（P = 0.014）。
这项试点研究提供了概念验证，即BFA对SCI神经性疼痛的调节具有临床意义。
