Medical device company NanoVibronix has reported successful trial results for the use of PainShield in treating patients with trigeminal neuralgia.
PainShield is an ultrasound pain therapy system that uses slow release ultrasound to deliver fast relief. The product claims to deliver localized energy to relieve pain and to induce soft tissue healing in patients.
The product has been designed to be effective in treating pain in nerves, muscles, joints and soft tissue through delivery of a localized ultrasound, and induces soft tissue healing in targeted areas.
It has received 510(k) clearance from the US Food and Drug Administration (FDA), CE Mark approval in Europe and Health Canada’s approval as well.
Trigeminal Neuralgia, also known as prosopalgia, suicide disease, or Fothergill’s disease is a neuropathic disorder characterized by episodes of intense pain in the face, originating from the trigeminal nerve.
It is considered to be one of the most, chronically painful conditions and is associated with high suicide rate directly attributable to the condition. In this condition, the pain spreads over the face and down the neck.
It is estimated that nearly 280,000 individuals in the US and 7 million across the world suffer from this condition. Currently, treatments are limited to medications including opioids and surgical interventions and have a high rate of recurrence.
NanoVibronix conducted a double blinded trial in the US with 59 patients suffering with unilateral trigeminal neuralgia. Among the patients, 30 were in active treatment group and 29 were in control group.
The values which were assessed include Visual Analog Scale (VAS) pain score, both baseline prior to trial and VAS pain score at the end of the study. The study also assessed breakthrough medications per week at the start of the trial and breakthrough medications per week at the end of the trial and particular focus was put on the use of opoids.
The study noted that there was a significant difference in the outcomes of the two groups relative to pain, quality of life, and breakthrough medications taken, which were directly rrelated to pain experienced during treatment.
The control group saw an improvement in baseline scores of 2.3% compared to the treatment group which saw 55.2% improvement in baseline scores.
Besides, the control group also saw a reduction in breakthrough pain medication of 1.5% compared to the treatment group which saw 46.4% reduction in breakthrough pain medication. In addition, there was an improvement in uninterrupted sleep.
NanoVibronix CEO Brian Murphy said: “We are very pleased to report the final results of our PainShield study for patients with Trigeminal Neuralgia. We saw a dramatic improvement in both pain scores and the use of pain medications such as opioids. We look forward to having these results published in a leading medical journal and aggressively marketing the device to physicians in order to help the millions of patients worldwide suffering from this painful and debilitating condition.”