Study of the Effectiveness of Vibrotactile Sensory Stimulation in Fibromyalgia Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 77
- 试验地点
- 2
- 主要终点
- 101-point verbal rating scale (VRS)
研究概览
简要总结
The purpose of this study is to investigate the effectiveness of low-intensity and prolonged vibrotactile sensory stimulation on symptom relieve in fibromyalgia patients.
详细描述
The trial will last up to 8 weeks for each subject and includes:
Three weeks treatment 1 (sham or actual) Two week washout Three weeks treatment 2 (sham or actual) Vibrotactile sensory stimulation will consist on whole-body stimulation with mechanical stimuli of pallesthetic type at high rate, low intensity and long daily duration.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
a sham device identical to the active device
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •A diagnosis of fibromyalgia according to the American College of Rheumatology (ACR) (Arthritis Rheum, 1990;33:160-172)
- •Clinical symptoms are not a consequence of other medical disorder (although the presence of other disorders is not an exclusion criterion)
- •Diagnoses established by an expert on fibromyalgia.
- •Stable treatment of chronic use.
- •Subject demonstrates an understanding of the study and a willingness to participate as evidenced by voluntary written informed consent.
排除标准
- •Generalized inflammatory articular or rheumatic disease.
- •Heavily exercise for 12 hours prior to fMRI assessment
- •Severe, non-stable medical, endocrinological or neurological disorder.
- •Psychotic disorder or drug abuse.
研究组 & 干预措施
Active treatment
Vibrotactile sensory stimulation
干预措施: Vibrotactile stimulation (Device)
Sham
Identical device. No vibration
干预措施: Vibrotactile stimulation (Device)
结局指标
主要结局
101-point verbal rating scale (VRS)
时间窗: 3 weeks
Change on fibromyalgia key symptoms rated using 101-point verbal rating scale (combining pain, fatigue and subjective cognitive problems).
次要结局
- Associated symptom improvement(3 weeks)
研究者
Jesus Pujol
Principal Investigator
Neurovoxel SLP