Evaluation of Nerivio Remote Electrical Neuromodulation Device for Managing Headache and Pain in Patients With Temporomandibular Disorder Aged 12 and Above

What this Trial Is About

Temporomandibular disorders TMD are a group of conditions affecting the jaw muscles, joint, and nearby structures, often causing pain and headaches. This study explores the use of Remote Electrical Neuromodulation REN, a device-based therapy, to manage headache and TMD-related pain by activating a natural pain regulation system that is often impaired in these patients. The research focuses on understanding how REN can address pain and symptom severity in patients aged 12 years and older with chronic TMD. Participants will use the Nerivio REN device, which delivers electrical stimulation to the upper arm to trigger the bodys pain inhibitory pathways. Treatment is self-administered once daily for 45 minutes over a 6-week period, with additional use allowed as needed for pain flare-ups. The study includes a 4-week baseline phase without treatment, followed by the 6-week intervention phase. Participants control the device through a smartphone app, facilitating home use. Throughout the study, participants will report their symptoms daily using an electronic diary app. Researchers will assess changes in maximum pain levels, jaw pain, jaw function, headache pain, and patient impressions of change over 10 weeks. Safety and adherence to treatment will be monitored, with the aim to evaluate RENs potential role for managing TMD and headache symptoms. The total study duration includes baseline and treatment phases lasting 10 weeks combined.

An Open Label Study Assessing REN Treatment in Headache Management in Temporomandibular Disorders