NCT02571010已完成不适用
Pilot Study to Evaluate the Effectiveness of Somatosensory Rehabilitation of Pain by Vibrotactile Stimulation on Static Mechanical Allodynia of Less Than Three Months Duration
CRRF La Châtaigneraie2 个研究点 分布在 1 个国家目标入组 17 人开始时间: 2015年10月1日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 17
- 试验地点
- 2
- 主要终点
- Change of baseline in reduction of surface of allodynia area
研究概览
简要总结
This study aims to demonstrate that somatosensory rehabilitation of pain associated with static mechanical allodynia has superior efficacy over placebo treatment as well as over spontaneous changes.
详细描述
This is a monocenter study. 45 patients will be enrolled in the study, allocated by randomization in 3 arms of 15 patients each.
During the 38 week duration of the study, enrolled patients will be assessed at:
- initial evaluation (first week of the study),
- intermediary evaluation for every week and every modification of intensity of pain,
- final evaluation at 10 weeks,
- follow-up evaluation at 6 months.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Eligibility Criteria
- •Male or female patients aged ≥18 years;
- •Static mechanical allodynia for less than 3 months, whatever its etiology and topography;
- •Probable peripheral or central neuropathic pain or defined according to the IASP criteria;
- •Neuropathic pain diagnostic questionnaire DN4 score ≥ 4/10;
- •Chronic pain with average intensity ≥ 4/10;
- •Analgesic treatment unchanged within 15 days prior to screening, and not planned to be modified during the study;
- •Patient who can attend follow-up visits during the study;
- •Patient affiliated to a health insurance plan or entitled;
- •Patient must be able to give informed consent in accordance with ICH GCP guidelines and local legislation and/or regulations.
排除标准
- •Patient with neuralgia (spontaneous pain) with or without allodynia;
- •Patient not able to participate actively to the rehabilitation exercises for physical reason, cognitive reason (ability to understand instructions) or behavioural reason (e.g. addiction...);
- •Patient with complex regional pain syndrome (type I);
- •Patients for whom cares cannot avoid any touch with allodynia area;
- •Patient previously treated by a transcutaneous electrical nerve stimulation (TENS);
- •Prior treatment by somatosensory rehabilitation;
- •Duration of stay in the medical center < 11 weeks;
- •Patient with cognitive disorder;
- •Allodynia area of the patient presenting with conditions not recommended for vibrotactile stimulation: wound, unhealed nerve suture, recent skin transplantation, fragile organ such as eye.
结局指标
主要结局
Change of baseline in reduction of surface of allodynia area
时间窗: At baseline, each week during the 10 week treatment period and at 6 months
Evaluate by the 15 g mono filament (Allodynographie) the reduction of surface of allodynia area
次要结局
- Analgesics consumption(At 6 months)
- Afterglow effect(At 6 months)
- Change of baseline in reduction of pain(At baseline, at each week, at 10 weeks and at 6 months)
- Change of baseline in reduction of allodynia intensity(At baseline, at each week, at 10 weeks and at 6 months)
- Change of baseline of patient's satisfaction with regard to received care(At baseline, at each week, at 10 weeks and at 6 months)
研究者
研究点 (2)
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