The study results determined that the HeadaTerm TENS device showed a fast-acting treatment of acute migraines
WAT Medical has unveiled positive results from a randomised controlled clinical trial, demonstrating that the HeadaTerm TENS therapy offers a fast treatment for acute migraines.
The medical technology firm said that its HeadaTerm TENS device showed 11.8% decrease in pain, which is better rate than many available acute migraine medications.
HeadaTerm is a wearable anti-migraine device that deploys specifically designed electrical stimulation to target pain receptors on the central nervous system, by releasing pain-countering neurotransmitters.
The company said that its reusable anti-migraine device offers low cost physical therapy based on electrical stimulation, without using any drugs, and avoids any potential side-effects.
WAT Medical has obtained the regulatory approval for the device from the US Food and Drug Administration (FDA), along with other international medical agencies including Health Canada, CE, TGA and Israel.
Clinical trial of WAT Medical’s HeadaTerm TENS device for the treatment of migraines
A team of scientists led by Nihat M Hokenek at the emergency department of Kartal Dr. Lütfi Kirdar training and research hospital in Istanbul, Turkey, has conducted a blind, randomised and controlled study on the HeadaTerm device.
In the study, patients were divided into 2 groups, a control group and a verum group. Patients who used the device for the first time were placed in the verum group, and both the groups were provided with visually indistinguishable devices.
The patients from both the groups were subjected to the TENS therapy for a total of 20 minutes, and the perceived changes in pain intensity were recorded at the 20 and 120 minutes after therapy initiation, using the visual analog scale (VAS).
The study evaluated the individual needs of patients for additional treatment, after 120 minutes and their self-reported comfort levels were measured using a Likert-type verbal scale.
Furthermore, from a pool of 151 patients, who were assessed after being admitted to the emergency ward, 39 patients were assigned for each of the control and verum groups.
The study results determined that TENS therapy carried out by HeadaTerm showed a fast-acting treatment of acute migraines.