A Pilot Study of the Safety and Feasibility of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Ocular Pain
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Eye Pain
- Sponsor
- VA Office of Research and Development
- Enrollment
- 40
- Locations
- 1
- Primary Endpoint
- Screen failure rate
- Status
- Completed
- Last Updated
- last year
Overview
Brief 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.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Screen failure rate
Time Frame: 1 year
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
Side-effect frequency and severity
Time Frame: 1 year
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 to peak change in numerical rating scale (NRS, 0-10)
Time Frame: 1 year
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.
Enrollment rate
Time Frame: 1 year
Percentage of individuals who meet pre-screening requirements, are told about the study, and are consented and enrolled into the study
Treatment compliance rate
Time Frame: 1 year
Calculation of the percentage of individuals who complete at least 75% of treatment session.
Secondary Outcomes
- Rate of uncertainty in participant treatment allocation guess(1 year)
- Percentage of individuals who score 100% on checklist for proper use of TENS device(1 year)