NCT05531643

Pilot Study of TENS for Ocular Pain

A Pilot Study of the Safety and Feasibility of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Ocular Pain

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: VA Office of Research and Development · Federal
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Eye Pain

Interventions

Type	Name	Description
DEVICE	Active Cefaly Dual (R)	Transcutaneous electrical nerve stimulation (TENS) device with electrode placement at the forehead. A biphasic rectangular wave 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.
DEVICE	Sham Cefaly Dual (R)	Transcutaneous electrical nerve stimulation (TENS) device with electrode placement at the forehead. A 1Hz wave will be delivered for 20 minutes at 1mA.

Timeline

• Start date: 2022-10-03
• Primary completion: 2024-11-30
• Completion: 2024-11-30
• First posted: 2022-09-08
• Last updated: 2025-01-27

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study