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
39
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.
Miami VA Healthcare System, Miami, FL
Miami, Florida, United States
Reported Device-related Side-effects
An open-ended question 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. Presence, description of symptom, severity of symptoms, participant assessment of device/treatment-relatedness of symptoms, and desire or actual discontinuation of device use will be recorded.
Time frame: 6 months
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: 6 months
Number of Screen Failures
The number 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: 6 months
Treatment Compliance Rate
Count of the number (and calculated percentage) of individuals who reported completing at least 75% of treatment sessions.
Time frame: 6 months
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: baseline
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: 6 months
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