A Device to Enhance TENS Analgesic Effectiveness

增强 TENS 镇痛效果的装置

• 批准号: 6790357
• 负责人: Danielle de Clercq
• 金额: $ 9.96万
• 依托单位: TALARIA, INC.
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-08-18 至 2006-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6790357
• 关键词: analgesia; backache; bioengineering /biomedical engineering; biomedical equipment development; chronic pain; clinical biomedical equipment; clinical research; clinical trials; electrostimulus; heat stimulus; human subject; human therapy evaluation; hyperthermia therapy; portable biomedical equipment

DESCRIPTION (provided by applicant): In 1965, Melzack and Wall described the physiologic mechanisms by which stimulation of large diameter non-pain sensory nerves could reduce the amount of unpleasant activity carried by pain nerves. This landmark observation published in Science was termed the "gate control theory" and offered a model to describe the interactions between various types of the sensory pathways in the peripheral and central nervous systems. The model described how non-painful sensory input such as mild electrical stimulation could reduce or gate the amount of nociceptive (painful) input that reached the central nervous system. The gate-control theory stimulated research that lead to the creation of new medical devices such as transcutaneous electrical nerve stimulators (TENS). In brief, TENS works by electrically "blocking" pain impulses carried by peripheral nerves. TENS is widely used and endorsed by the pain management guidelines of both the AHCPR and American Geriatric Society (Gloth 2001). However a significant number of patients fail to achieve adequate relief with TENS or fail within six months of starting treatment (Fishbain et al., 1996). This project addresses a major clinical challenge and a large commercial opportunity, how to improve the analgesic effectiveness of TENS. Studies indicate that both heat (Abeln et al, 2002 and Weingand et al, 2001) and vibration (Lundeberg, 1983, 1984a, and Guieu 1990) also produce analgesia and may enhance TENS effectiveness. Advances in manufacturing, battery technology, miniaturization, and microchip processing now allow for the creation of a small portable patient controlled heating device that can be used with commercial TENS devices. This project will produce such a device and examine whether heat delivered by the device increases the effectiveness of TENS. The primary hypothesis is that heat will increase the analgesic effectiveness of TENS in subjects who suffer from myofascial low back pain. The secondary hypothesis is that heat is as effective as TENS in providing pain relief in these subjects.

描述（由申请人提供）：1965年，梅尔扎克（Melzack）和沃尔（Wall）描述了生理机制，通过这种机制，刺激大直径非皮革感觉神经可以减少疼痛神经携带的不愉快活性的量。科学上发表的这个具有里程碑意义的观察被称为“栅极控制理论”，并提供了一个模型来描述周围和中枢神经系统中各种类型的感觉途径之间的相互作用。该模型描述了非呼吸的感觉输入（例如轻度电刺激）如何减少或限制到达中枢神经系统的伤害感受（疼痛）输入的量。栅极控制理论刺激了导致创建新医疗设备（例如经皮神经刺激剂（TENS））的研究。简而言之，TENS通过外周神经带来的电气“阻塞”疼痛冲动来起作用。 AHCPR和美国老年学会的疼痛管理指南广泛使用，并认可TENS（Gloth 2001）。但是，大量患者在开始治疗后的六个月内未能通过数十个或失败实现足够的缓解（Fishbain等，1996）。该项目解决了一个重大的临床挑战和巨大的商业机会，即如何提高TEN的镇痛有效性。 研究表明，热量（Abeln等，2002和Weingand等，2001）和振动（Lundeberg，1983，1984a和Guieu 1990）也会产生镇痛，并可能提高TENS有效性。现在，制造，电池技术，小型化和微芯片处理的进步可以创建可与商用数TENS设备一起使用的小型便携式患者受控加热设备。该项目将产生这样的设备，并检查设备输送的热量是否会提高TEN的有效性。主要假设是，热量会增加患有肌筋膜下腰痛的受试者的镇痛有效性。次要假设是，热量在这些受试者提供疼痛方面的效果与数十种相同。