Fibromyalgia Activity Study with TENS "FAST"

使用 TENS“FAST”进行纤维肌痛活动研究

• 批准号: 9127091
• 负责人: Leslie J Crofford
• 金额: $ 71.53万
• 依托单位: UNIVERSITY OF IOWA
• 依托单位国家: 美国
• 财政年份: 2013
• 资助国家: 美国
• 起止时间: 2013-07-01 至 2018-06-30
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9127091
• 关键词: Accelerometer; Address; Aerobic Exercise; American; Analgesics; Basic Science; Brain Stem; Chronic; Clinical; Clinical Trials; Degenerative polyarthritis; Effectiveness; Electric Stimulation; Exercise; Fatigue; Fibromyalgia; Frequencies; Fright; Health Professional; Home environment; Individual; Laboratories; Malaise; Measures; Midbrain structure; Modality; Movement; Muscle; Musculoskeletal Pain; Neuraxis; Neurons; Nociception; Outcome; Outcome Measure; Pain; Pain Threshold; Pain management; Pathway interactions; Patients; Performance; Persons; Pharmaceutical Preparations; Pharmacotherapy; Physical Function; Physical activity; Physiological; Physiology; Placebos; Population; Postoperative Pain; Process; Quality of life; Questionnaires; Rest; Rheumatology; Skin; Social Work; Spinal Cord; Symptoms; Syndrome; Testing; Transcutaneous Electric Nerve Stimulation; Translating; United States Food and Drug Administration; Walking; Woman; Work; college; daily functioning; diffuse noxious inhibitory control; double-blind placebo controlled trial; efficacy testing; exercise intervention; fibromyalgia pain; fitness; improved; improved functioning; innovation; instrument; men; pain inhibition; patient population; public health relevance; responders and non-responders; standard care; trial design

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).

描述（由申请人提供）：与纤维肌痛相关的疼痛会干扰日常功能，工作和社交活动，导致生活质量降低。纤维肌痛的人也有很大的疲劳和对运动的恐惧。患有纤维肌痛的人在中枢神经系统中表现出疼痛神经元的兴奋性增强，并抑制疼痛。因此，纤维肌痛患者的主要治疗方法之一必须集中于缓解疼痛，以使该人在家里和工作中都能更独立地发挥作用。卫生专业人员使用经牙性电神经刺激（TENS）来通过皮肤进行电刺激以控制疼痛。来自PIS实验室的基础科学研究表明，TENS激活了降低疼痛抑制途径以抑制疼痛神经元的兴奋性。因此，用于治疗TEN的理想患者人群将是中心兴奋性增强和抑制作用的理想患者。纤维肌痛是一种情况。我们假设在纤维肌痛患者中使用TEN将减轻与运动相关的疼痛，并通过恢复中心抑制作用减少中心兴奋性，并且这种减少的疼痛和/或中心兴奋性会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4个特定目标检验这一假设。 AIM 1：测试纤维肌痛患者的反复使用在与运动相关的疼痛上的有效性，并将其随机分配给三种治疗方法：标准护理，安慰剂数和活跃数TENS。 AIM 2：测试是否减轻疼痛是否会导致疲劳和对运动的恐惧以及生活质量的提高以及生活质量的提高。结果指标将通过直接评估加速度计以及执行特定功能任务的日常活动来包括身体功能。 AIM 3：确定主动TENS是否改变了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归一化相关。我们将评估临床评估的反应者与非反应者中这些生理参数的变化。 AIM 4：通过与纤维肌痛撞击问卷（FIQ-R）的修订版相比，确定Promis是否是纤维肌痛的有用结果。