The Clinical Effect of Low-Intensity Electromagnetic Field Neurostimulation in Fibromyalgia Syndrome Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 91
- 试验地点
- 2
- 主要终点
- Change in Tender Point Pain Threshold
研究概览
简要总结
The purpose of this study is to determine whether persons treated with a low-intensity, noninvasive form of cortical electrical stimulation experience a reduction in symptoms of fibromyalgia different than persons receiving a sham treatment. Outcome measures include reduction in patient pain levels and improvement in sleep measures.
详细描述
There is increasing acceptance that pain in fibromyalgia is a result of dysfunctional sensory processing in the spinal cord and brain. Electrical cortical stimulation is a device-based form of therapy that is increasingly being considered as an adjuvant to current medical modalities for the treatment of chronic pain conditions such as fibromyalgia. The investigators propose that stimulation of cortical areas believed to be involved in dysfunctional sensory processing may have a beneficial influence on fibromyalgia symptoms.
The aim of this randomized double blind, placebo controlled study is to evaluate the efficacy, safety, and tolerability of noninvasive cortical stimulation in the management of fibromyalgia symptoms. More specifically, an active treatment group of subjects will receive the study's cortical stimulation protocol twice a week for 11 weeks and will be evaluated within 14 days following end of treatment, for a total timeframe of 13 weeks. In comparison, a similar group of subjects will receive the same treatment protocol without the actual stimulation signal being applied. The signal utilized is a modulated form that permits very low-intensity signals to pass through outer tissues with less attenuation due to tissue impedance. The signals are of a sufficiently low strength that they are below the level of perception. Hence subjects cannot feel the signal, and are therefore blinded to treatment arm. Investigators and clinical staff are also blinded. Outcome measures include post-treatment to baseline changes in tender points, sleep characteristics as measured by visual analog scales, and outcomes instruments including the Fibromyalgia Impact Questionnaire.
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
- Quadruple (Participant, Care Provider, 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
- •Age 18 through 65 years
- •An ability to read and comprehend English
- •Completion of a minimum of grade 8 education
- •Diagnosis of fibromyalgia in 1999 or earlier, by a rheumatologist or appropriate specialist, and currently meeting the American College of Rheumatology 1990 criteria
- •Symptoms for at least 48 months with no recent remission of symptoms to any degree
排除标准
- •Developmental disabilities, or significant psychological disorder (except depression and anxiety disorders) for which treatment has become necessary
- •A history of chronic infection or chronic condition such as lupus, rheumatoid arthritis, Parkinson's Disease, multiple sclerosis, hepatitis, history of meningo-encephalitis, polio, seizures, or metastatic cancer
- •Current pregnancy, or plans to become pregnant during the study period.
- •Any other condition deemed to pose a risk to the patient at the discretion of the investigators
- •Exposure to other neurostimulation systems, or electroconvulsive therapy
- •Any implantable electronic device
- •Any present or previous litigation regarding their physical condition
结局指标
主要结局
Change in Tender Point Pain Threshold
时间窗: Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment
Tender point pain threshold is derived by summing the dolorimetry-based pain pressure thresholds measured on a subject for each of the 18 tender points sites specified by the American College of Rheumatology for fibromyalgia classification. The range of dolorimeter values for each tender point site is 0-4 (units are kilograms per square centimeter, i.e. kg/cm\^2). Higher numbers represent greater pressure required to elicit pain, and are thus indicators of "less pain" sensitivity at the tender point. Since 18 tender points are measured on a patient and their individual dolorimeter values summed, the range of tender point pain threshold values is 0-72. A higher score represents less overall pain sensitivity. The change in tender point pain threshold is determined by subtracting values at baseline from values at end of treatment. Thus a positive difference represents pain improvement (i.e.. a better outcome). A negative difference represents pain worsening (i.e. a worse outcome).
次要结局
- Change in Number of Positive Tender Points(Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment)
- Change in Fibromyalgia Impact Questionnaire Overall Score(Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment)
- Change in Fibromyalgia Impact Questionnaire Pain Visual Analog Scale(Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment)
- Change in Fibromyalgia Impact Questionnaire Sleep Satisfaction Visual Analog Scale(Total timeframe 13 weeks: baseline followed by 11 weeks of treatment with outcome assessed within 14 days following end of treatment)
研究者
Jeffrey B. Hargrove
Principal Investigator
McLaren Regional Medical Center