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”经皮刺激剂（TENS），这些刺激剂（TENS）可能被证明是可行的辅助手段或用于管理最近发作“急性”疼痛的药物的替代方法。长期以来，TENS一直用于“慢性”疼痛管理。该设备的复杂性使它们在短期“急性”应用中令人难以置信。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，遥控激活，多个脉冲功能，耐用性，操作简化，扩展电池寿命以及几乎在身体上任何地方的放置能力。遥控器（RF）功能允许现在开发的刺激设备可以由患者轻松控制 - 无需在所有其他数十个单位上进行延长电线 - 无论将单位放置在身体上，例如，背部，颈部，颈部，肩膀，臀部，臀部，臀部等。在一项双盲研究中用药，以确定治疗急性疼痛的有效性。如果有TENS被证明是患者的有效，简单且舒适的穿着，那么Cyclotec AMT设备将发现一个重要的市场生态位，因为数十个众多的警告或警告，而众所周知，毒品的长期至重度副作用。