Efficacy of Non-invasive NESA Neuromodulation in Fibromyalgia: a Randomised, Triple-blind Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Change in Pain assessed by VAS
研究概览
简要总结
Fibromyalgia is a chronic condition that causes pain throughout the body, fatigue and other symptoms. Among the most common clinical symptoms are sleep and anxiety disorders. All these symptoms are very disabling and have a negative impact on the quality of life of these people.
There is currently no curative treatment for this pathology and current treatments focus their efforts on reducing the intensity of the symptoms. The current approach is mainly pharmacological, with the possible side effects that this entails.
详细描述
The NESA XSIGNAL® device is a non-invasive, low-frequency neuromodulation device that uses microcurrents to restore the electrical balance in the body. This technology is approved as medical equipment and is CE marked (attached in separate files).
This non-invasive neuromodulation equipment is beginning to show promising results in patients with sleep disorders. So it can be a useful tool to reduce the impact on the quality of life of people with fibromyalgia.
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
- •Patients over 18 years of age
- •Diagnosis of Fibromyalgia meeting ACR 1990/20101,2 criteria, made by a physician, documented by a clinical report.
- •Diagnosis of Fibromyalgia made at least 12 months ago
- •Stable baseline treatment in the month prior to inclusion in the study
- •Signed informed consent
- •In normal condition and mentally competent to participate in the study.
- •Able to complete the study questionnaires.
排除标准
- •Have any of the following contraindications for treatment with NESA XSIGNAL®: pacemakers, internal bleeding, not applying electrodes to skin in poor condition, with ulcerations or wounds, acute febrile processes, acute thrombophlebitis and/or phobia of electricity.
- •Failure to sign the informed consent form.
- •Active chronic inflammatory joint diseases.
- •Active neurological diseases with central or peripheral nervous system involvement.
- •Active systemic autoimmune diseases
- •Psychotic disorders
- •Active concomitant neoplastic or infectious processes
- •Medication changes in the month prior to study inclusion or throughout the duration of the study.
结局指标
主要结局
Change in Pain assessed by VAS
时间窗: Baseline and up to three weeks
The instrument will be used to measure the change of pain before and after the intervention will be the Visual Analogue Scale (VAS). Participants will be asked to mark the level of their pain on a 100 mm, no hatched VAS scale marked at one end as "no pain" and at the other as "worst pain imaginable".
Change in Sleep quality
时间窗: Baseline and up to three weeks
The Pittsburgh Sleep Quality Index (PSQI) will be used. It consists of 19 self-administered questions and 5 questions assessed by the patient's partner or roommate (if available). Only the self-administered questions are included in the score. The higher the total score, the worse the sleep quality. Thus, a total score less than or equal to five on the Pittsburgh scale indicates that, in general, your sleep quality is optimal, while a total score greater than five suggests that you have sleep problems, of greater or lesser severity.
次要结局
- Functional capacity(Baseline and up to three weeks)
- Psychosomatic assessment(Baseline and up to three weeks)
- Sleep assessment (time elapsed between each sleep phase)(Baseline and up to three weeks)
研究者
Aníbal Báez Suárez
Clinical Professor
University of Las Palmas de Gran Canaria