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临床试验/NCT01918826
NCT01918826已完成不适用

Evaluation of the Analgesic Efficiency of the Transcutaneous Neurostimulation in the Charcot Syndrome Marie Tooth on the Pains of Lower Limbs

Centre Hospitalier Universitaire de Nice2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2012年8月31日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
入组人数
10
试验地点
2
主要终点
Visual Analogue Scale

研究概览

简要总结

The Charcot syndrome Marie Tooth is the most frequent hereditary neuromuscular diseases: there is no curative treatment at present, on the other hand precautionary measures can be taken (physiotherapy, port of splints, orthopaedic surgery and technical assistants). In the literature and in our recent study (evaluation of the pain in the disease of CMT - Reference center of the neuromuscular diseases - CHU Bow) the frequency of the pain is important varying from 66 to 96 % cases, affecting especially hands and lower limbs. The care of the pain in the Charcot syndrome Marie Tooth is not codified. The transcutaneous neurostimulation(TENS) is a not medicinal and not invasive therapeutics, without any brought back collateral effect, used at the same time in the chronic pain and acute since 1960, as well for the neuropathic pains that musculo-scrawny. No study was realized this day on the use of the TENS with analgesic aim in the CMT. We suggest studying the analgesic efficiency of the TENS in the Charcot syndrome Marie Tooth on the pains of lower limbs, the most frequent painful location in our recent works.

The main objective will be to analyze the improvement of the pain of lower limbs, based on the decrease of the analogical visual scale(ladder) (EVA), at least 30 %.

The secondary objectives will be to estimate repercussions on the functional capacities ( ONLS), the quality of life (SF(sci-fi) 12), the satisfaction (EVA), the global impression(printing) of change ( PGIC), the consumption of analgesic, DN4, NPSI (Neuropathic Pain Symptom Inventory), Concise Questionnaire of the Pains ( QCD), HAD (Hospital Anxiety and Depression scale).

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age included between 18 and 75 years
  • Affected by CMT confirmed on clinical, family criteria, electrophysiological and / or genetics
  • pain ≥ 3 months
  • EVA pain ≥ 4/10
  • patient having given his written consent and lit(enlightened)
  • patient susceptible to be followed regularly during at least 3 months
  • Patient member to the Social Security

排除标准

  • Expanding patients of associated neurological pathology
  • Patients having resorted to the TENS in the last 3 months
  • Medical history of cancers, collagen and quite other pathology which can interfere with the experimental procedure
  • Patient carrier of a pacemaker or an active implantable medical device
  • Cutaneous hurt on the territory to be stimulated
  • Venous or arterial thrombosis or thrombophlebitis in the territory to be stimulated
  • Patient participant in another biomedical research on the pain or the period of exclusion of which in a study is not ended
  • Patient under guardianship or deprived of all his liberties

研究组 & 干预措施

TENS active

Active Comparator

NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC ACTIVE

干预措施: TENS (Device)

TENS placebo

Placebo Comparator

NEUROSTIMULATION TRANSCUTANEE AIMED ANALGESIC PLACEBO

干预措施: TENS (Device)

结局指标

主要结局

Visual Analogue Scale

时间窗: At 3 month

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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