Efficacy of the Quell Wearable Device for Fibromyalgia
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Patients' Global Impression of Change
研究概览
简要总结
This study is designed for patients with primary fibromyalgia (FM) pain. The overall aim of the study is to determine the effect of the high frequency Quell device to manage FM compared with a low frequency device. Investigators hypothesize that those assigned to using the high frequency Quell device will report reduced pain compared with those using the low frequency Quell device; with those using the high frequency device also showing more improvement in sleep, mood, and level of activity. Investigators also hypothesize that frequency of using the Quell (increased tolerability and adherence) will be correlated with greater reduction in pain.
详细描述
The Quell is battery powered with rechargeable batteries and is strapped to participant's upper calf with a velcro band. It has been cleared by the FDA for safety. It is designed to improve fibromyalgia by the principles of transcutaneous electrical stimulation of nerves much like a traditional transcutaneous electrical nerve stimulator (TENS) unit. Investigators expect to enroll approximately 130 subjects in this study. Participants will be equally randomized to one of two experimental groups: High Frequency Quell group (N=65) or Low Frequency Quell group (N=65). This study hopes to find out whether low frequency or high frequency stimulation is most useful among persons 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
- Double (Participant, Investigator)
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
- •have chronic pain related to FM for > 3 months' duration
- •average 4 or greater on a pain intensity scale of 0 to 10
- •are able to speak and understand English
- •have a smartphone (Android or iPhone)
排除标准
- •diagnosis of cancer or any other malignant disease
- •acute osteomyelitis or acute bone disease
- •present or past DSM-V diagnosis of schizophrenia, delusional disorder, psychotic disorder, or dissociative disorder that would be judged to interfere with study participation
- •any clinically unstable systemic illness judged to interfere with treatment
- •a pain condition requiring urgent surgery
- •an active substance use disorder, such as cocaine or IV heroin use (positive on the Mini International Neuropsychiatric Interview; M.I.N.I. v.5.0), that would interfere with study participation
- •have an implanted cardiac pacemaker, defibrillator, or other implanted device
结局指标
主要结局
Patients' Global Impression of Change
时间窗: 3 months
The questionnaire reflects a patient's belief about the efficacy of treatment. The Patients' Global Impression of Change (PGIC) is a 7-point scale (1-7) depicting a patient's rating of overall improvement. Patients rate their change as 1="very much improved," 2="much improved," 3="minimally improved," 4="no change," 5="minimally worse," 6="much worse," or 7="very much worse." Lower values represent a better outcome.
次要结局
- The Brief Pain Inventory(Baseline, 3 months)
- Revised Fibromyalgia Impact Questionnaire(Baseline, 3 months)
- Pain Disability Index(Baseline, 3 months)
- Pain Catastrophizing Scale(Baseline, 3 months)
- Hospital Anxiety and Depression Scale(Baseline, 3 months)
- Helpfulness Rating(Post-treatment at 3 months)
研究者
Robert N. Jamison, PhD
Professor of Anaesthesia, Harvard Medical School
Brigham and Women's Hospital