NCT01262131已完成2 期
A Randomized, Double-blind, Placebo-controlled Evaluation of the Application of Magnetic Fields Using the Resonator Device for the Treatment of Fibromyalgia: Pilot Study Protocol
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 13
- 主要终点
- Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale.
研究概览
简要总结
The purpose of this study is to see if a device called the Resonator can help to reduce pain and improve aspects of health and quality of life for people with fibromyalgia.
详细描述
The purpose of this pilot study is to assess the efficacy of the Resonator device as an adjunctive therapy to reducing pain and improving aspects of health and quality of life that are relevant to individuals 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
- Triple (Participant, 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
- •Current diagnosis of fibromyalgia made by the study Principal Investigator (PI) according to the American College of Rheumatology 1990 Criteria for the Classification of Fibromyalgia.
- •Rating of current Degree of Pain on the 0-10 Numeric Pain Intensity Scale of 4 or greater.
- •Subject's use of pain relief medication(s) has been stable over the past 30 days, and subject is willing and able to maintain pre-existing use of pain relief medication(s) as his or her sole pain relief medication use, as needed, throughout study participation.
- •Subject's use of insomnia medication(s) has been stable over the past 30 days, and subject is willing and able to maintain this existing use of insomnia medication(s) as his or her sole insomnia relief medication(s), as needed, throughout study participation.
- •Subject has been on current (or no) medication regimen, unchanged for at least 30 days prior to study enrollment, and is willing and able to maintain that regular medication regimen, unchanged, throughout study participation.
- •Willing and able to refrain from use of tender point injections throughout study participation.
- •Willing and able to abstain from partaking in other/new treatments to improve fibromyalgia symptoms during study participation.
- •Adequate contraceptive measures for female subjects. > 18 years of age or older.
- •Male or female.
排除标准
- •Any factors that might prevent the subject from completing a full course of therapy with the Resonator™ device, or from attending any of the scheduled study visits, or from completing any of the study measures.
- •Subject suffers from co-existent chronic pain condition(s) of non-fibromyalgia origin, such as osteoarthritis, low back pain, neck pain, painful diabetic neuropathy and postherpetic neuropathic pain, that cannot be distinguished in severity and/or in type/sensation of pain from the pain originating from the subject's condition of fibromyalgia.
- •Any other significant comorbidities that might impact the ability to evaluate the subject's satisfaction of the ACR 1990 Criteria for the Classification of Fibromyalgia, or for the subject to complete any of the study assessment tools.
- •Tender point injections received within the prior one month.
- •Current or past history of major psychiatric disturbance (e.g., schizophrenia, bipolar disorder, substance abuse).
- •Known inflammatory rheumatic disease.
- •Epilepsy/history of seizures/taking medication for epilepsy.
- •HIV and other autoimmune disorders.
- •Active cancer or treatment for cancer within last 6 months.
- •Active infection(s).
- •History of ECT
- •Uncontrolled Hypertension.
- •Advanced Pulmonary Disease.
- •Unstable cardiac disease.
- •Prosthetics or implants comprised of ferrous metals.
- •Pacemakers, vagus nerve stimulators, or other functional electrical stimulators such as those commonly used for pain.
- •Consumption of more than 21 alcoholic drinks per week.
- •Pregnant, breast feeding, or planning pregnancy prior to end of study participation.
- •Developmental disability or other cognitive impairment that would in the judgment of the PI impair adequate comprehension of the informed consent form or complete any of the study-related activities.
- •Worker's compensation, receipt of disability or present/past litigation for monetary compensation pertaining to subject's fibromyalgia condition.
- •Participation in other research within 30 days of study enrollment.
结局指标
主要结局
Mean Change in 3-recording Average of the Subjects Daily Pain Rating on the 0-10 Numeric Pain Intensity Scale.
时间窗: 2 weeks (baseline to end of treatment)
Minimum scale value is '0' which represents 'no pain at all' and is the best outcome. Maximum scale value is '10 which represents the 'worst pain imaginable' and is the worse outcome.
次要结局
未报告次要终点
研究者
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