← Back to Search

Behavioural Intervention

TENS for Eye Pain

N/A
Waitlist Available
Led By Elizabeth R Felix, PhD
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
On a stable medication regimen for at least the past 3 months
At least 18 years of age
Must not have
Patients with confirmed signs of tear dysfunction
Presence of ocular diseases that are the likely cause of pain (i.e., corneal and conjunctival scarring, corneal edema, uveitis, iris transillumination defects, etc.)
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year

Summary

This trial will test whether transcutaneous electrical nerve stimulation (TENS) is an effective treatment for ocular pain in veterans with dry eye syndrome.

Who is the study for?
This trial is for adults with chronic eye pain linked to dry eye syndrome, who haven't used TENS for facial conditions and have had persistent eye pain of moderate intensity for at least 6 months. They should be on a stable medication regimen. Those with certain ocular diseases, using specific medical devices like pacemakers, or pregnant individuals cannot participate.
What is being tested?
The study tests the safety and effectiveness of TENS—a non-drug method that uses electrical nerve stimulation—for treating chronic ocular pain in veterans. Participants will receive either an active TENS device (Cefaly Dual) or a sham (placebo) version to compare outcomes.
What are the potential side effects?
TENS is generally safe but may cause skin irritation where the electrodes are placed, muscle twitching during use, or discomfort from the electrical current. It's not suitable for those with certain electronic medical implants.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My medication has not changed in the last 3 months.
Select...
I am 18 years old or older.
Select...
I have had eye pain for at least 6 months.
Select...
My average eye pain is 4 or higher on a scale of 0 to 10.
Select...
I have never used TENS for facial pain.
Select...
I experience eye pain that feels like nerve pain.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I have been diagnosed with tear dysfunction.
Select...
I have eye conditions like scarring or swelling that cause pain.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Enrollment rate
Screen failure rate
Side-effect frequency and severity
+2 more
Secondary study objectives
Percentage of individuals who score 100% on checklist for proper use of TENS device
Rate of uncertainty in participant treatment allocation guess
Other study objectives
Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting adherence to treatment protocol
Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting change in pain (Numerical Rating Scale)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active TENSExperimental Treatment1 Intervention
TENS delivered for 20 minutes to the forehead via the active Cefaly (R) device; at least 3 times per week in-home; for 6 months.
Group II: Sham TENSPlacebo Group1 Intervention
Sham TENS delivered for 20 minutes to the forehead via the sham Cefaly (R) device; at least 3 times per week in-home; for 6 months.

Find a Location

Who is running the clinical trial?

VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,557 Total Patients Enrolled
Elizabeth R Felix, PhDPrincipal InvestigatorMiami VA Healthcare System, Miami, FL
2 Previous Clinical Trials
45 Total Patients Enrolled

Media Library

TENS (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05531643 — N/A
Eye Pain Research Study Groups: Active TENS, Sham TENS
Eye Pain Clinical Trial 2023: TENS Highlights & Side Effects. Trial Name: NCT05531643 — N/A
TENS (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05531643 — N/A
~13 spots leftby Dec 2025
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top