At a glance
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A Pilot Study of the Safety and Feasibility of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Ocular Pain
In Brief
A clinical study evaluating High frequency forehead TENS and Low frequency forehead TENS for Eye Pain. Completed, enrolled 39 participants across 1 site.
Detailed Summary
Approximately 20% of Veterans have a diagnosis of dry eye (DE) syndrome which is often accompanied by ocular pain that significantly impacts activities of daily living. Currently very few treatments are available for chronic ocular pain, likely because the mechanisms underlying this type of pain have only recently begun to be studied. New treatments that target the neuropathic mechanisms contributing to this type of pain are needed. The proposed research provides a crucial step in addressing the lack of treatments for neuropathic ocular pain by validating the methodology needed to support a randomized controlled trial of transcutaneous electrical nerve stimulation (TENS). TENS is a non-pharmacologic, non-addictive, non-invasive treatment that has been shown to be effective in other chronic pain conditions. The present pilot study aims to address the need for preliminary support of safety and efficacy of TENS for ocular pain, t to advance the study of new treatments for the long-term relief of chronic ocular pain and its impact on health.
Study Details
Timeline
Arms & Interventions
high frequency (60Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months.
low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months.
Interventions
Transcutaneous electrical nerve stimulation (TENS) device with electrode placement at the forehead. Biphasic rectangular impulses at 60Hz frequency will be delivered for a maximum of 20 minutes at a maximum amplitude of 16mA. Participant may halt amplitude before it reaches maximum amplitude. The device has previously been cleared by the FDA for use in migraine patients.
Transcutaneous electrical nerve stimulation (TENS) device with electrode placement at the forehead. A 3Hz biphasic square wave will be delivered for 20 minutes up to a maximum amplitude of 16mA.