A Device to Enhance TENS Analgesic Effectiveness

描述（由申请人提供）：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。发表在《科学》杂志上的这一具有里程碑意义的观察结果被称为“门控理论”，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。该模型描述了非疼痛感觉输入（如轻度电刺激）如何减少或控制到达中枢神经系统的伤害性（疼痛）输入量。门控理论刺激了研究，导致了新的医疗设备的创造，如经皮电神经刺激器（TENS）。简而言之，TENS通过电“阻断”由外周神经传递的疼痛脉冲来工作。 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，大量的患者不能用TENS获得足够的缓解或在开始治疗的六个月内失败（Fishbain等人，1996年）。该项目解决了一个主要的临床挑战和一个巨大的商业机会，如何提高TENS的镇痛效果。 研究表明，热（Abeln等，2002和Weingand等，2001）和振动（Lundeberg，1983，1984a和Guieu 1990）也产生镇痛作用，并可能增强TENS的有效性。制造、电池技术、小型化和微芯片处理的进步现在允许创建可与商业TENS设备一起使用的小型便携式患者控制的加热设备。该项目将生产这样的设备，并检查设备提供的热量是否增加了TENS的有效性。主要的假设是，热将增加TENS在患有肌筋膜下腰痛的受试者中的镇痛效果。第二个假设是，在这些受试者中，热疗法在缓解疼痛方面与TENS一样有效。

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.