Fibromyalgia Activity Study with TENS "FAST"

描述（由申请人提供）：与纤维肌痛相关的疼痛干扰日常功能、工作和社会活动，导致生活质量下降。患有纤维肌痛的人也有大量的疲劳和对运动的恐惧。纤维肌痛患者表现出中枢神经系统疼痛神经元的兴奋性增强和疼痛抑制减少。因此，纤维肌痛患者的主要治疗方法之一必须侧重于缓解疼痛，以使患者在家庭和工作中更独立地发挥作用。经皮电神经刺激（TENS）由健康专业人员使用，通过皮肤提供电刺激以控制疼痛。来自PI实验室的基础科学研究表明，TENS激活下行疼痛抑制通路以抑制疼痛神经元的兴奋性。因此，治疗TENS的理想患者人群是中枢兴奋性增强和抑制性降低的人群;纤维肌痛就是这样一种情况。我们假设，对纤维肌痛患者应用TENS将减少运动相关疼痛，并通过恢复中枢抑制来降低中枢兴奋性，并且这种疼痛和/或中枢兴奋性的降低将减少疲劳和对运动的恐惧，从而改善功能和生活质量。我们将通过四个具体目标来验证这一假设。目标1：测试重复使用TENS对纤维肌痛患者运动相关疼痛的有效性，随机分配三种治疗：标准治疗，安慰剂TENS和活性TENS。目标二：测试通过TENS减轻疼痛是否会导致疲劳和运动恐惧的伴随减少，以及功能和生活质量的增加。结果测量将包括通过使用加速度计直接评估日常活动的身体功能，以及执行特定的功能任务。目标3：确定积极的TENS是否改变纤维肌痛患者的疼痛处理，以及临床症状的改善是否与疼痛处理生理学的正常化相关。我们将根据临床评估，评价应答者与非应答者的这些生理参数的变化。目的4：通过与修订版纤维肌痛影响问卷（FIQ-R）进行比较，确定PROMIS是否是纤维肌痛的有用结局。

DESCRIPTION (provided by applicant): Pain associated with fibromyalgia interferes with daily function, work, and social activities resulting in a decreased quality of life. People with fibromyalgia also have a significant amount fatigue and a fear of movement. People with fibromyalgia show enhanced excitability of pain neurons in the central nervous system and reduced pain inhibition. Therefore, one of the main treatments for patients with fibromyalgia must focus on pain relief to allow the person to function more independently both at home and at work. Transcutaneous electrical nerve stimulation (TENS) is used by health professionals to deliver electrical stimulation through the skin for pain control. Basic science studies, from the PIs laboratory, show that TENS activates descending pain inhibitory pathways to inhibit excitability of pain neurons. Thus, the ideal patient population for the treatment of TENS would be one in which there is enhanced central excitability and reduced inhibition; fibromyalgia is such a condition. We hypothesize that application of TENS to patients with fibromyalgia will reduce movement-related pain and reduce central excitability by restoring central inhibition, and that this decrease in pain and/or central excitability will reduce fatigue and fear of movement, thereby improving function and quality of life. We will test this hypothesis through 4 Specific Aims. Aim 1: test the effectiveness of repeated use of TENS on movement-related pain in people with fibromyalgia with random assignment to three treatments: standard care, placebo TENS and active TENS. Aim 2: test if pain reduction by TENS results in a concomitant decrease in fatigue and fear of movement, and an increase in function and quality of life. Outcome measures will include physical function by directly assessing daily activity with an accelerometer, as well as performing specific functional tasks. Aim 3: determine if active TENS alters pain processing in people with fibromyalgia and if improvement in clinical symptoms correlates with normalization of pain processing physiology. We will evaluate change in these physiologic parameters in responders versus non-responders as assessed clinically. Aim 4: determine if PROMIS is a useful outcome for fibromyalgia by comparing to the revised version of the fibromyalgia impact questionnaire (FIQ-R).