A Novel RF TENS Device for Acute Pain Management

描述（由申请人提供）：Cyclotec AMT, Inc.正在开发“非侵入性”经皮电刺激器（TENS），可能被证明是治疗近期发作的“急性”疼痛的药物的可行辅助或替代药物。长期以来，TENS一直用于“慢性”疼痛治疗。设备的复杂性使它们难以用于短期“急性”应用；该技术有望非常适合的应用。Cyclotec针对急性适应症的“新颖”发展包括：小型化、无线操作、远程控制激活、多脉冲功能、耐用性、操作简化、延长电池寿命，以及几乎可以放置在身体任何地方的能力。远程控制（RF）功能允许患者轻松控制目前正在开发的刺激装置-无需所有其他TENS装置所需的延长电线-无论装置放置在身体的哪个位置，例如背部，颈部，肩部，臀部等。在完成12个功能原型装置的开发后，将在不同的临床地点进行初步试验研究，以确定与药物联合使用的疗效，以及在双盲研究中不使用药物的情况下确定治疗急性疼痛的有效性。如果TENS被证明像公司希望的那样有效、简单和舒适，那么Cyclotec AMT设备将找到一个重要的市场利基，因为TENS几乎没有注意或警告，而众所周知，药物具有长期的中度到严重的副作用。

DESCRIPTION (provided by applicant): Cyclotec AMT, Inc. is developing 'non-invasive' transcutaneous electrical stimulators (TENS) that may prove to be viable adjuncts to or alternatives for drugs for management of recent onset "acute" pain. TENS has long been used for "chronic" pain management. The device complexities have made them prohibitive for short-term 'acute' applications; an application for which the technology promises to be well suited for. Cyclotec's 'novel' developments for acute indications include: miniaturization, wireless operation, remote control activation, multiple pulsing features, durability, simplification of operation, extended battery life, and the capability of placement virtually anywhere on the body. The remote control (RF) features allow the stimulation devices now in development to be easily controlled by the patient - without the extension wires necessary on all other TENS units - no matter where the units are placed on the body, e.g., back, neck, shoulder, hip, and etc. Upon completion of development of 12 functional prototype units, initial pilot investigations at various clinical sites will be performed to establish efficacy in conjunction with medication and with the absence of medication in a double-blinded study to determine effectiveness in treatment of acute pain. Should TENS prove as effective, simple and comfortable to wear by patients as the company hopes they will be, Cyclotec AMT devices will find a significant market niche as TENS has few cautions or warnings while drugs are well known to have long-term moderate to severe side effects.