CompletedNot Applicable

Pilot Study of TENS for Ocular Pain

United States39 participantsStarted 2022-10-03

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * male or female * all races and ethnicities * at least 18 years of age * persistent eye pain for at least 6 months * average eye pain intensity of 4 or more on a 0-10 numerical rating scale * on a stable medication regimen for at least the past 3 months * naïve to TENS use for orofacial conditions * eye pain having neuropathic-like characteristics Exclusion Criteria: * presence of ocular diseases that are the likely cause of pain (i.e., corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, etc.) * contraindication to TENS (i.e., pacemaker, cardioverter defibrillator, neuro-stimulation (brain or spinal cord), bone growth stimulations, indwelling blood pressure monitors, epilepsy, pregnancy) * patients with confirmed signs of tear dysfunction * current participation in another study with an investigational drug or device within one month prior to screening

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Since this was a pilot study using TENS (transcutaneous electrical nerve stimulation) for eye pain, what did the results suggest about whether it actually helped reduce pain scores, and does my doctor think those early findings are relevant to my situation?
2Because this trial tracked device-related side effects as a primary outcome, what kinds of side effects were reported with using TENS around the eye area, and are any of them a concern given my specific eye condition?
3This was listed as a pilot study with no formal phase, which means it was likely designed to test feasibility rather than prove the treatment works — so should I be looking at more established treatments for my eye pain before considering anything based on this early research?
4The trial measured treatment compliance, meaning they were tracking how consistently patients were able to use the TENS device — is this something my doctor thinks would realistically fit into my daily routine, and what does poor compliance mean for how well it might work?
5Now that this trial is completed, has my doctor seen or heard any published results from it, and are there any follow-up studies planned that might be a better fit for me to discuss?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reported Device-related Side-effects

Timeframe: 6 months

Time to Peak Change in Numerical Rating Scale (NRS, 0-10)

Timeframe: 6 months

Number of Screen Failures

Timeframe: 6 months

Treatment Compliance Rate

Timeframe: 6 months

Trial details

NCT IDNCT05531643

SponsorVA Office of Research and Development

Sponsor typeFED

Study typeINTERVENTIONAL

Primary completion2024-11-30

Results submitted2025-11-28

View on ClinicalTrials.gov More Eye Pain trials

Plain-language summary

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.