A Novel RF TENS Device for Acute Pain Management

用于急性疼痛管理的新型 RF TENS 设备

• 批准号: 6585887
• 负责人: Frank Andrasik
• 金额: $ 17.42万
• 依托单位: CYCLOTEC ADVANCED MEDICAL TECHNOLOGIES
• 依托单位国家: 美国
• 财政年份: 2002
• 资助国家: 美国
• 起止时间: 2002-09-30 至 2005-03-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6585887
• 关键词: analgesia; biomedical equipment development; chronic pain; clinical research; electronic stimulator; human subject; miniature biomedical equipment; pain; portable biomedical equipment; telemetry

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.

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），这可能被证明是可行的替代品或替代药物，用于管理最近发生的“急性”疼痛。TENS长期以来一直用于“慢性”疼痛管理。设备的复杂性使得它们对于短期的“急性”应用是禁止的;该技术有望很好地适用于这种应用。Cyclotec针对急性适应症的“新”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放置在身体任何地方的能力。远程控制（RF）特征允许患者容易地控制现在正在开发的刺激设备-而无需所有其他TENS单元上所必需的延长线-无论单元被放置在身体上的何处，例如，背部、颈部、肩部、臀部等。在完成12个功能原型单元的开发后，将在多个临床地点进行初步试点研究，以在双盲研究中确定与药物联合使用和不使用药物的疗效，以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几乎没有注意事项或警告，而药物众所周知具有长期的中度至重度副作用。