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经皮神经电刺激(TENS)治疗癌症骨痛的可行性研究。

Feasibility study of Transcutaneous Electrical Nerve Stimulation (TENS) for cancer bone pain.

机构信息

Professor of Palliative Medicine, Lancaster University, Lancaster, United Kingdom.

出版信息

J Pain. 2010 Apr;11(4):351-9. doi: 10.1016/j.jpain.2009.08.002. Epub 2009 Oct 22.

DOI:10.1016/j.jpain.2009.08.002
PMID:19853518
Abstract

UNLABELLED

This multicenter study assessed the feasibility of conducting a phase III trial of transcutaneous electrical nerve stimulation (TENS) in patients with cancer bone pain recruited from palliative care services. Eligible patients received active and placebo TENS for 1 hour at site of pain in a randomized crossover design; median interval between applications 3 days. Responses assessed at 30 and 60 minutes included numerical and verbal ratings of pain at rest and on movement, and pain relief. Recruitment, tolerability, adverse events, and effectiveness of blinding were also evaluated. Twenty-four patients were randomised and 19 completed both applications. The intervention was well tolerated. Five patients withdrew: 3 due to deteriorating performance status, and 2 due to increased pain (1 each following active and placebo TENS). Confidence interval estimation around the differences in outcomes between active and placebo TENS suggests that TENS has the potential to decrease pain on movement more than pain on rest. Nine patients did not consider that a placebo was used; the remaining 10 correctly identified placebo TENS. Feasibility studies are important in palliative care prior to undertaking clinical trials. Our findings suggest that further work is required on recruitment strategies and refining the control arm before evaluating TENS in cancer bone pain.

PERSPECTIVE

Cancer bone pain is common and severe, and partly mediated by hyperexcitability. Animal studies suggest that Transcutaneous Electrical Nerve Stimulation can reduce hyperalgesia. This study examined the feasibility of evaluating TENS in patients with cancer bone pain in order to optimize methods before a phase III trial.

摘要

本多中心研究评估了从姑息治疗服务中招募的癌症骨痛患者进行经皮神经电刺激(TENS)的 III 期试验的可行性。符合条件的患者以随机交叉设计在疼痛部位接受 1 小时的主动和安慰剂 TENS;应用之间的中位数间隔为 3 天。在 30 分钟和 60 分钟评估的反应包括静息和运动时疼痛的数字和口头评分,以及疼痛缓解。还评估了招募、耐受性、不良事件和盲法的有效性。24 名患者被随机分配,19 名患者完成了两次应用。干预措施耐受性良好。有 5 名患者退出:3 名因功能状态恶化,2 名因疼痛增加(1 名在接受主动和安慰剂 TENS 后各 1 名)。主动和安慰剂 TENS 之间结局差异的置信区间估计表明,TENS 有可能比静息时更能减轻运动时的疼痛。有 9 名患者不认为使用了安慰剂;其余 10 名患者正确识别了安慰剂 TENS。在进行临床试验之前,姑息治疗中的可行性研究非常重要。我们的发现表明,在评估癌症骨痛中的 TENS 之前,需要进一步研究招募策略和完善对照臂。

观点

癌症骨痛很常见且严重,部分由过度兴奋介导。动物研究表明,经皮神经电刺激可以减轻痛觉过敏。本研究检查了在癌症骨痛患者中评估 TENS 的可行性,以便在 III 期试验之前优化方法。

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