First Relief, a PENS (percutaneous electrical neurostimulation) device, has been cleared by the FDA for multiple treatments up to 56 days for symptomatic relief of chronic, intractable pain from diabetic peripheral neuropathy. It is applied behind the ear and delivers continuous pulses of a low-level electrical current over several days.
The approval was based on a study that tested First Relief against a placebo and another device previously cleared by the US Food and Drug Administration. The study was conducted at the Jeevak Multispeciality Hospital in Warangal, India, renowned for the treatment of diabetes. The single center, three-arm, randomized, controlled, parallel assignment, double blinded, prospective study involved 63 patients age 30 to 74. The devices were applied on a bi-weekly basis for 16 weeks. The primary efficacy endpoint was pain intensity measured through Visual Analog Scale (VAS) score and the secondary efficacy endpoints are vibration perception threshold (VPT) value, insomnia severity index (ISI), overall neuropathy limitations scale (ONLS), Hamilton rating scale for anxiety. No complications or adverse events were observed in any of the subjects during the study period.
The VAS pain score analysis showed a significant reduction in the pain score of patients being treated with First Relief from start of the treatment to the end. This improvement persisted throughout the 90-day follow-up, suggesting that the treatment was a long-term improvement in neuropathic pain and not a short-term improvement. The secondary outcome measures (VPT, Insomnia, ONLS and HAM) also showed similar improvements to the pain score, showing significant improvement in sleep and mood as the neuropathic pain decreased.
DyAnsys Inc. is a global company headquartered in California with subsidiaries in Switzerland and India. For more information go to: www.dyansys.com
Reprint courtesy of PRNewswire; Photo courtesy of DyAnsys