Startup develops portable device for pain relief

A new firm supported by FAPESP has created user-friendly miniaturized devices to relieve pain, enhance athletic performance and speed up muscle rehabilitation by means of transcutaneous electrical nerve stimulation.

By Elton Alisson

Agência FAPESP – Widespread curiosity was aroused during the 2014 FIFA World Cup soccer championships in Brazil by a device resembling a knee protector that was strapped to Brazilian striker Neymar’s right leg to treat an injury that he sustained during a match against Chile.

The device was a self-adhesive disposable unit that is used to treat chronic or acute muscle pain via electrical stimulation. The pulses that are delivered by the unit are directed and controlled by the user. The device is frequently used by other members of Brazil’s national soccer squad and is prescribed by physical therapists for players in premier clubs such as São Paulo and Corinthians.

Developed by Medecell, a startup based in Botucatu, São Paulo State, the concept behind the unit is being adapted for other applications in the project “Development of a self-administered equipment at low cost and to be used only in transcutaneous electrical nerve stimulation (TENS)”, which FAPESP supports under its Innovative Research in Small Business (PIPE) program.

“We identified other applications for the device, such as relief from menstrual cramps [dysmenorrhea], pain during or after sexual intercourse [dyspareunia] and migraines or headaches due to temporomandibular joint dysfunction, as well as performance enhancement for athletes and muscle rehab for fitness practitioners,” said Maurício Marques de Oliveira, lead investigator for the project.

Functional prototypes of devices for these applications have been tested in clinical trials. The findings of these trials are currently being written up for publication, and the product engineering stage is well underway. Industrial-scale production is scheduled to begin in the second half of 2015.

The device that was worn by Neymar is called Tanyx, and it is sold in drugstores in Brazil and Chile.

Electrical stimulation

Although all of the devices use TENS, each employs different electrical stimulation parameters such as pulse frequency and intensity, Oliveira told Agência FAPESP. In the case of Tanyx, for example, its frequency is 85 Hz, and its intensity ranges from 10 to 30 milliamperes (mA).

“We optimize the electrical stimulation for each application, depending on whether it involves pain relief or muscle rehab,” Oliveira said.

TENS has long been prescribed by physicians and other healthcare professionals to treat pain caused by a wide variety of conditions, but until the advent of this device and its derivatives the technique was applied almost exclusively in physical therapy clinics.

Even now, the application of TENS is relatively unusual because of the cost and bulk of the standard equipment, as well as the training required to operate it, Oliveira explained.

When Medecell set out to develop a miniaturized device that would be inexpensive, disposable and easy for users themselves to handle and operate without professional supervision, it began by searching patent databases worldwide to see if any such device already existed.

Having found nothing, the company developed its first device. Launched in 2011, the device consists of a small control box with two larger adhesive patches (electrodes), one on each side, and it runs on a lithium battery for ten hours.

The device can easily be applied by the user, who can control the pulse intensity to obtain relief from arm, leg, back and shoulder pain in sessions that last up to 20 minutes.

“The idea was that the device could be used to control pain for a total period equivalent to the duration of a packet of painkillers,” Oliveira said.

“Of course, it offers several advantages over painkillers. It combats pain without the side-effects of anti-inflammatory and analgesic medications.”

The device’s effectiveness was tested in clinical trials at the teaching hospital belonging to the University of São Paulo’s Ribeirão Preto School of Medicine (FMRP-USP).

The results of the clinical trials were the basis of the registration of the device with the National Public Health Surveillance Agency (ANVISA) and the US Food & Drug Administration (FDA). The technology has been patented in Argentina, Australia, Canada, China, the European Union, India, Japan, Mexico, Russia and South Africa, as well as in Brazil and the US.

“Once we’d registered the device with the FDA, companies became interested in distributing it in the US. We also plan to begin selling it this year in Canada and in other Latin American and European countries,” Oliveira said.

Clinical trials

A version of the device that can be applied to the pre-pubic area to treat dysmenorrhea was tested in clinical trials at the University of Campinas Women’s Hospital (CAISM-UNICAMP) in São Paulo State. A version designed to relieve headache will be tested as soon as the first pilot batch has been produced.

A version designed to enhance athletic performance and to facilitate muscle rehabilitation was tested in clinical trials at Hospital Sírio Libanês in the city of São Paulo.

The results of the study showed that the device, which can be placed on various muscle groups, causes a significant increase in blood flow to the electrically stimulated muscles compared with muscles that are not electrically stimulated.

“We also conducted a study at the University of São Paulo’s School of Physical Education & Sports, and the findings showed a highly significant improvement in the performance of the athletes who took part,” Oliveira said.

“These new applications will be protected by utility model and invention patents.”