Feasibility of Self-treatment of Painful Diabetic Neuropathy Using Electrical Vasomotor Nerve Stimulation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Successful treatment cycles
研究概览
简要总结
Electrical stimulation with EVNS (Electrical Vasomotor Neuro Stimulation), a methodology used by a specific group of neurostimulators known under various names, has proven its benefit in Painful Diabetic Neuropathy (PDN). However, due to the impaired mobility from Diabetic Neuropathy, a part of subjects did not finish the 10 days treatment in the outpatient clinic. Another part of the target group decided not to participate at all for the same reason.
The current study investigates the feasibility, safety and performance of a newly developed EVNS device, called Releaf™, optimised for HOME treatment,
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Painful Diabetic Neuropathy (DN4 positive) and insufficiently treated with any combination of 2 of the following drugs: Duloxetine (Cymbalta), venlafaxine (Efexor), ami- or nortriptyline, gabapentine, pregabaline (Lyrica) or the use of carbamazepine or capsaïcine (Qutenza).
- •Both feet are present
- •Able and willing to complete the treatments in 10 days in a row and completion of questionnaires.
- •Being in a mental and physical state to perform home self-treatment with Releaf™ for 10 consecutive days, if necessary with adequate assistance of caregiver.
- •Being in a mental and physical state to understand and complete the informed consent form as well as the research questionnaires.
排除标准
- •In case of other evident causes for painful neuropathy,
- •Currently participating in another interventional investigational study
- •Significant peripheral arterial disease,
- •Active foot ulceration or other skin conditions that prevent the application of electrodes on the skin
- •Current alcohol or other substance abuse (use of alcohol over the recommended limits of less than 21 units of alcohol per week in men and 14 units in women, Trimbos Intitute),
- •Epilepsy,
- •Pregnancy,
- •Presence of a medical device based on electrical stimulation, cardiac pacemaker and/or implantable cardioverter defibrillator or any other active implant
- •Allergy to electrode contact area or to the adhesive substance of the electrode.
研究组 & 干预措施
EVNS treatment
EVNS, see intervention
干预措施: Releaf (Device)
结局指标
主要结局
Successful treatment cycles
时间窗: Day 11
The successful treatment cycles applied at home, defined as cycles with at least 8/10 successful (full 35 minutes) treatment sessions, derived from the adherence determined by recording device usage and intensity setting which is downloaded from device after its retrieval
Reported usability
时间窗: Day 10
Usability by the User Questionnaire
Side-effects
时间窗: Day 1-10
The number and severity of reported side-effects of HOME-EVNS, gathered via telephonic consulting on treatment day 1,3 and 8 and via user-initiated incoming calls to the PI
Use of helpdesk
时间窗: Day 1-10
The number of help requests to service desk.
次要结局
- Quality of life score(Before start, after 1 month, after 3 months)
- Neuropathic pain(Before start, after 1 month, after 3 months)