A Novel RF TENS Device for Acute Pain Management

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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.