The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial.
The Fibromyalgia Transcutaneous Electrical Nerve Stimulation in Physical Therapy Study Protocol: A Multisite Embedded Pragmatic Trial.
复制标题
物理治疗中的纤维肌痛经皮电神经刺激研究方案：多站点嵌入式实用试验。
DOI：
10.1093/ptj/pzac116
复制
发表时间：
2022
期刊：
影响因子：
3.2
通讯作者：
Zimmerman,
中科院分区：
文献类型：
--
作者：
Post,AndrewA;Dailey,DanaL;Bayman,EmineO;Chimenti,RuthL;Costigan,Michele;Franck,Carla;Huff,Trevis;Johnson,Elizabeth;Koepp,Maxine;Lafontant,David-Erick;McCabe,MeganE;Neill-Hudson,Tina;Vance,CarolGT;VanGorp,Barb;Zimmerman,
目的经皮神经电刺激 (TENS) 是一种非药物干预措施，可通过皮肤提供电流以产生镇痛。本研究的主要目的是检查在常规物理治疗中添加 TENS 是否可以改善物理治疗临床环境中纤维肌痛患者的运动诱发疼痛。方法纤维肌痛 TENS 物理治疗研究是一项由美国国立卫生研究院帮助结束成瘾长期计划资助的 III 期嵌入式实用临床试验。该试验将采用随机集群设计，包括 7 个州 6 个医疗保健系统 24 至 30 个物理治疗诊所的 110 多名物理治疗师。诊所将随机分为 TENS 或无 TENS，并根据医疗保健系统和诊所规模进行分层。该计划将招募 600 名参与者，所有参与者都按照物理治疗师的规定完成物理治疗。 TENS 诊所的参与者将在物理治疗诊所和家中活动时每天至少使用 TENS 2 小时。主要结果是，当参与者坐和站 5 次（坐和站测试）时，运动引起的疼痛从基线到第 60 天有所减轻，采用 11 点数字评分量表。次要结局包括静息疼痛和疲劳、疼痛干扰、纤维肌痛疾病活动、运动引起的疲劳、疲劳的多维评估、体力活动的快速评估、患者对变化的整体印象以及通过帮助结束成瘾长期计划支持的研究共享的通用数据元素。影响这项研究的结果将为医疗保健政策制定者、临床医生和保险公司提供纤维肌痛患者 TENS 的有效性数据。这项研究的数据还将为未来非药物干预和慢性肌肉骨骼疼痛的实用试验提供信息。
ObjectivesTranscutaneous electrical nerve stimulation (TENS) is a nonpharmacological intervention that provides an electrical current through the skin to produce analgesia. The primary purpose of this study is to examine if the addition of TENS to routine physical therapy improves movement-evoked pain in individuals with fibromyalgia in a physical therapy clinical setting.MethodsFibromyalgia TENS in Physical Therapy Study is a phase III embedded pragmatic clinical trial funded through the National Institutes of Health Helping to End Addiction Long-Term Initiative. This trial will utilize a randomized cluster design that includes more than 110 physical therapists in 24 to 30 physical therapy clinics within 6 health care systems and 7 states. Clinics will be randomized to TENS or No-TENS, stratified by health care system and clinic size. The plan is to enroll 600 participants, with all participants completing physical therapy as prescribed by their physical therapist. Participants at TENS clinics will utilize TENS for a minimum of 2-hour per day while at the physical therapy clinic and at home when active. The primary outcome is reduction in movement-evoked pain from baseline to day 60 on an 11-point numeric rating scale when participants sit and stand 5 times (Sit and Stand Test). Secondary outcomes include resting pain and fatigue, pain interference, fibromyalgia disease activity, movement-evoked fatigue, multidimensional assessment of fatigue, rapid assessment of physical activity, patient global impression of change, and common data elements shared across studies supported through the Helping to End Addiction Long-Term Initiative.ImpactThe findings from this study will provide effectiveness data on TENS for individuals with fibromyalgia for health care policymakers, clinicians, and insurers. Data from this study will also inform future pragmatic trials for nonpharmacological interventions and chronic musculoskeletal pain conditions.