Effects of a 4 Week AVACEN Treatment on Pain Perception in Fibromyalgia - An Open Label Study
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 22
- 试验地点
- 1
- 主要终点
- Widespread Pain Index (WPI) Score After 4 Weeks Treatment
研究概览
简要总结
Hypothesis: Daily use of the AVACEN Thermal Exchange System for 4 weeks will show improved Fibromyalgia pain and functioning markers, as assessed by biomarkers and clinical and psychological assessment. This non-invasive device is able to rapidly raise the core body temperature of the user by placing a hand in a vacuum chamber and resting it upon a heating element. The change in body temperature may change the sympathetic nervous system's activity and thereby reduce Fibromyalgia pain.
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 99 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Fibromyalgia diagnosis
- •Over the age of 18
- •Understands English
- •Not pregnant/planning to become pregnant
- •Average pain of 4 or greater over the last week (10 point scale)
- •Fibromyalgia pain lasting longer than 6 months
排除标准
- •Pregnant/Planning to become pregnant
- •Major unstable psychiatric illness
- •Major, uncontrolled systemic illness for which you may be hospitalized in the next 6 months
研究组 & 干预措施
Treatment
Subjects with Fibromyalgia undergo twice daily use of the non-invasive device for 4 weeks.
干预措施: AVACEN Thermal Exchange System (Device)
结局指标
主要结局
Widespread Pain Index (WPI) Score After 4 Weeks Treatment
时间窗: 4 Weeks
Widespread Pain Index (WPI) Score Range is 0 to 19 points. 0 = Lowest pain score (Best Outcome). 19 = Highest pain score (Worst Outcome). Widespread pain was defined as pain occurring in at least 2 contralateral body quadrants, in addition to the axial skeleton for at least 3 consecutive months.
Tender Point Count (TPC) After 4 Weeks Treatment
时间窗: 4 Weeks
Tender Point Count (TPC) Score Range is 0 to 18. 0 = Lowest pain score (Best Outcome). 18 = Highest pain score (Worst Outcome). The criteria required confirming tenderness used 4kg of pressure applied to a total of 18 specified tender point sites. Fibromyalgia is diagnosed with a minimum tenderness count in 11 of 18 points.
Symptom Severity (SS) Score After 4 Weeks Treatment
时间窗: 4 Weeks
Symptom Severity (SS) Score Range is 0 to 12. 0 = Lowest pain score (Best Outcome). 12 = Highest pain score (Worst Outcome). The SS scale identifies the level of severity sum of 4 categories (Fatigue, Waking Unrefreshed, Cognitive Symptoms, Somatic Symptoms) over the past week, using this scale: 0 = no problem * slight or mild * moderate * severe: continuous, life-disturbing
次要结局
未报告次要终点