Applying Transcutaneous Auricular Vagus Nerve Stimulation to Treat Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Revised Fibromyalgia Impact Questionnaire (FIQR)
研究概览
简要总结
In this research study we want to learn more about if transcutaneous electrical nerve stimulation (TENS), a safe electrical stimulation tool, can relieve Fibromyalgia pain. A total of 60 subjects with Fibromyalgia will be enrolled in this study at Massachusetts General Hospital, Charlestown Navy Yard campus.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the American College of Rheumatology (ACR) 1990 classification criteria and the ACR 2010 diagnostic criteria for fibromyalgia as determined by clinicians.
- •Willingness to complete a 4-week, twice-a-day treatments.
- •At least a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.
排除标准
- •Diagnosed with medical conditions that are known to contribute to fibromyalgia symptomatology, such as thyroid disease, inflammatory arthritis, systemic lupus erythematosus, rheumatoid arthritis, myositis, vasculitis, or Sjogren's syndrome.
- •History of cardiac, respiratory, or nervous system disease that, in the investigator's judgment, precludes participation in the study because of a heightened potential for adverse outcome. For example: asthma or claustrophobia.
- •Personal history of medical or psychiatric illness as determined by investigator.
- •Pregnant or lactating.
- •Less than a 10th grade English-reading level; English can be a second language provided that the patients understand all questions used in the assessment measures.
研究组 & 干预措施
taVNS Group1
This group will receive taVNS for 4 weeks.
干预措施: Auricular transcutaneous electrical nerve stimulation device (Device)
taVNS Group 2
This group will receive taVNS for 4 weeks.
干预措施: Auricular transcutaneous electrical nerve stimulation device (Device)
结局指标
主要结局
Revised Fibromyalgia Impact Questionnaire (FIQR)
时间窗: Baseline, week 2 and week 4.
A change in the FIQR would indicate that participants are experiencing pain relief.
次要结局
- Patient Reported Outcomes Measurement Information System (PROMIS-29)(Baseline, week 2 and week 4.)
- Heart rate variability(Baseline and week 4.)
- Pain Catastrophizing Scale(Baseline, week 2 and week 4.)
- Blood inflammation markers (optional)(Baseline and week 4)
- power of oscillations in the alpha, theta, and gamma frequencies (optional)(Baseline and week 4.)
- Beck Depression Inventory-II (BDI-II)(Baseline and week 4.)
- Brief Quantitative Sensory Testing (QST)(Baseline and week 4.)
研究者
Jian Kong
Principle investigator
Massachusetts General Hospital