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，导致生活质量下降。患有纤维肌痛的人也会感到明显的疲劳和对运动的恐惧。患有纤维肌痛的人中枢神经系统中疼痛神经元的兴奋性增强，而疼痛抑制减弱。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，使患者能够在家庭和工作中更加独立地发挥作用。健康专业人员使用经皮神经电刺激 (TENS) 通过皮肤提供电刺激来控制疼痛。 PIs 实验室的基础科学研究表明，TENS 可以激活下行疼痛抑制通路，从而抑制疼痛神经元的兴奋性。因此，治疗 TENS 的理想患者群体是中枢兴奋性增强、抑制减少的患者群体。纤维肌痛就是这样一种病症。我们假设对纤维肌痛患者应用 TENS 将通过恢复中枢抑制来减轻运动相关疼痛并降低中枢兴奋性，并且疼痛和/或中枢兴奋性的减少将减少疲劳和对运动的恐惧，从而改善运动功能和质量生活。我们将通过 4 个具体目标来检验这一假设。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，随机分配至三种治疗方法：标准护理、安慰剂 TENS 和主动 TENS。目标 2：测试 TENS 减轻疼痛是否会同时减少疲劳和对运动的恐惧，并提高功能和生活质量。结果测量将包括通过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：确定主动 TENS 是否会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估有反应者与无反应者的这些生理参数的变化。目标 4：通过与修订版的纤维肌痛影响问卷 (FIQ-R) 进行比较，确定 PROMIS 是否是治疗纤维肌痛的有用结果。