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scrambler 疗法可能比基于指南的药物管理更有效地缓解慢性神经性疼痛:一项试点、随机、对照试验的结果。

Scrambler therapy may relieve chronic neuropathic pain more effectively than guideline-based drug management: results of a pilot, randomized, controlled trial.

机构信息

Delta Research & Development, Centro Ricerche Bioingegneria Medica, University of Rome "Tor Vergata," Rome, Italy.

出版信息

J Pain Symptom Manage. 2012 Jan;43(1):87-95. doi: 10.1016/j.jpainsymman.2011.03.015. Epub 2011 Jul 16.

Abstract

CONTEXT

Neuropathic pain is common, disabling, and often difficult to treat.

OBJECTIVES

To compare guideline-based drug management with Scrambler therapy, a patient-specific electrocutaneous nerve stimulation device.

METHODS

A clinical trial with patients randomized to either guideline-based pharmacological treatment or Scrambler therapy for a cycle of 10 daily sessions was performed. Patients were matched by type of pain including postsurgical neuropathic pain, postherpetic neuralgia, or spinal canal stenosis. Primary outcome was change in visual analogue scale (VAS) pain scores at one month; secondary outcomes included VAS pain scores at two and three months, pain medication use, and allodynia.

RESULTS

Fifty-two patients were randomized. The mean VAS pain score before treatment was 8.1 points (control) and 8.0 points (Scrambler). At one month, the mean VAS score was reduced from 8.1 to 5.8 (-28%) in the control group, and from 8 to 0.7 points (-91%) in the Scrambler group (P<0.0001). At two and three months, the mean pain scores in the control group were 5.7 and 5.9 points, respectively, and 1.4 and 2 points in the Scrambler group, respectively (P<0.0001). More relapses were seen in polyradicular pain than monoradicular pain, but retreatment and maintenance therapy gave relief. No adverse effects were observed.

CONCLUSION

In this pilot randomized trial, Scrambler therapy appeared to relieve chronic neuropathic pain better than guideline-based drug management.

摘要

背景

神经性疼痛很常见,且具有致残性,往往难以治疗。

目的

比较基于指南的药物管理与 scrambler 疗法(一种针对个体的经皮神经电刺激设备)。

方法

对患者进行临床试验,随机分为基于指南的药物治疗或 scrambler 治疗,共 10 个疗程。患者按疼痛类型匹配,包括手术后神经性疼痛、带状疱疹后神经痛或椎管狭窄。主要结局是一个月时视觉模拟量表(VAS)疼痛评分的变化;次要结局包括 VAS 疼痛评分在两个月和三个月时的变化、疼痛药物的使用和感觉异常。

结果

52 名患者被随机分配。治疗前 VAS 疼痛评分的平均值为 8.1 分(对照组)和 8.0 分( scrambler 组)。一个月时,对照组 VAS 评分从 8.1 降至 5.8(-28%), scrambler 组从 8 降至 0.7(-91%)(P<0.0001)。两个月和三个月时,对照组的平均疼痛评分分别为 5.7 和 5.9 分, scrambler 组分别为 1.4 和 2 分(P<0.0001)。多神经根性疼痛比单神经根性疼痛更容易复发,但再治疗和维持治疗可以缓解。未观察到不良反应。

结论

在这项初步的随机试验中, scrambler 疗法似乎比基于指南的药物治疗更能缓解慢性神经性疼痛。

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