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NCT05531643 · ClinicalTrials.gov registry record · NA
Pilot Study of TENS for Ocular Pain
A NA study, sponsored by VA Office of Research and Development.
- Completed
- Registry status
- NA
- Development phase
- 39
- Enrollment target
NCT05531643: Completed NA study, sponsored by VA Office of Research and Development.
NCT05531643 is a NA study that has completed, run by VA Office of Research and Development. The registered enrollment target is 39 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05531643, a NA study, has completed, sponsored by VA Office of Research and Development.
- COMPLETED
- Registry status
- NA
- Development phase
- 39 participants
- Enrollment target
Study 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.
Primary Outcome
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.
Interventions
- DEVICE High frequency forehead TENS
- DEVICE Low frequency forehead TENS
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 39 participants |
| Start Date | 2022-10-03 |
| Est. Completion | 2024-11-30 |
| Phase | NA |
What the finished NCT05531643 record still lists
NCT05531643 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 39 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (97% lower).
The record links to 0 conditions, and to 2 interventions - of which High frequency forehead TENS is the first listed.
NCT05531643 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05531643 about?
NCT05531643 is a clinical study titled "Pilot Study of TENS for Ocular Pain". 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 hav...
What is the current status of trial NCT05531643?
This trial is currently completed. It is a NA study. The enrollment target is 39 participants. The study started on 2022-10-03. Estimated completion is 2024-11-30.
What interventions are being tested in trial NCT05531643?
The interventions under investigation include: High frequency forehead TENS (DEVICE), Low frequency forehead TENS (DEVICE).
Who is sponsoring clinical trial NCT05531643?
This trial is sponsored by VA Office of Research and Development, which has 1,668 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05531643's enrollment target sits among peer trials
39 1536th of 2000 higher than 463 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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