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(申请人提供)：1965年，Melzack和Wall描述了刺激大直径非疼痛感觉神经可以减少疼痛神经携带的不愉快活动量的生理机制。这一里程碑式的观察结果发表在《科学》杂志上，被称为“门控制理论”，并提供了一个模型来描述外周和中枢神经系统中各种类型的感觉通路之间的相互作用。该模型描述了非痛性感觉输入，如轻微的电刺激，如何减少或减少到达中枢神经系统的伤害性(痛苦)输入量。门控制理论刺激了导致新医疗设备的创造的研究，如经皮神经电刺激器(TENS)。简而言之，TENS的工作原理是通过电“阻断”外周神经传递的疼痛冲动。 TENS被广泛使用，并得到AHCPR和美国老年学会疼痛管理指南的认可(Gloth 2001)。然而，相当数量的患者在开始治疗后的6个月内未能获得足够的缓解，或在开始治疗后6个月内失败(Fishbain等人，1996年)。该项目解决了一个重大的临床挑战和一个巨大的商业机会，即如何提高TENS的止痛效果。 研究表明，热(Abeln等人，2002和Weingand等人，2001)和振动(Lumdeberg，1983,1984 a，Guieu 1990)也产生止痛，并可能增强TENS的效果。在制造、电池技术、小型化和微芯片处理方面的进步，现在可以创造一种小型便携式患者控制加热设备，可以与商业TEN设备一起使用。该项目将生产这样一个装置，并检查该装置提供的热量是否增加了TENS的有效性。主要的假设是，在患有肌筋膜下腰痛的受试者中，高温会增加TENS的止痛效果。第二个假设是，在这些受试者中，高温和TEN一样有效地缓解了疼痛。