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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
40
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.
Transcutaneous electrical nerve stimulation (TENS) device with electrode placement at the forehead. A 1Hz wave will be delivered for 20 minutes at 1mA.
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States
Side-effect frequency and severity
An open-ended questionnaire of side-effects will be used to assess any bothersome changes in physical or mental health symptoms every 2 weeks during the 6-month at-home course of treatment. Severity, device/treatment-relatedness of symptoms, and desired or actual discontinuation of device use will be recorded.
Time frame: 1 year
Time to peak change in numerical rating scale (NRS, 0-10)
Calculation of time (weeks) to peak reduction in eye pain will be made based on NRS scores obtained every two weeks after initiation of intervention protocol.
Time frame: 1 year
Enrollment rate
Percentage of individuals who meet pre-screening requirements, are told about the study, and are consented and enrolled into the study
Time frame: 1 year
Screen failure rate
The percentage of individuals who meet pre-screening requirements, consent to study procedures, but who do not meet full criteria after screening visit is conducted
Time frame: 1 year
Treatment compliance rate
Calculation of the percentage of individuals who complete at least 75% of treatment session.
Time frame: 1 year
Percentage of individuals who score 100% on checklist for proper use of TENS device
The percentage of individuals who, after instruction, score 100% on checklist items for safe and proper use of the device.
Time frame: 1 year
Rate of uncertainty in participant treatment allocation guess
Percentage of individuals who rate at least moderate uncertainty in guessing which treatment arm they were allocated to.
Time frame: 1 year
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