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Behavioural Intervention
TENS for Eye Pain
N/A
Recruiting
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study 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.Check my eligibility
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.See study design
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 belowSelect...
My medication has not changed in the last 3 months.
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I am 18 years old or older.
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I have had eye pain for at least 6 months.
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My average eye pain is 4 or higher on a scale of 0 to 10.
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I have never used TENS for facial pain.
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I experience eye pain that feels like nerve pain.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Enrollment rate
Screen failure rate
Side-effect frequency and severity
+2 moreSecondary outcome measures
Percentage of individuals who score 100% on checklist for proper use of TENS device
Rate of uncertainty in participant treatment allocation guess
Other outcome measures
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
1,610 Previous Clinical Trials
3,305,134 Total Patients Enrolled
Elizabeth R Felix, PhDPrincipal InvestigatorMiami VA Healthcare System, Miami, FL
2 Previous Clinical Trials
55 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have a pacemaker, epilepsy, or any condition that prevents TENS use.My medication has not changed in the last 3 months.This criterion does not exclude anyone based on their race or ethnicity. All races and ethnicities are included.I am 18 years old or older.I am either male or female.I have been diagnosed with tear dysfunction.I have had eye pain for at least 6 months.My average eye pain is 4 or higher on a scale of 0 to 10.I have eye conditions like scarring or swelling that cause pain.I have never used TENS for facial pain.I experience eye pain that feels like nerve pain.
Research Study Groups:
This trial has the following groups:- Group 1: Active TENS
- Group 2: Sham TENS
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is this trial currently open for enrollment?
"Affirmative, according to information found on clinicaltrials.gov this medical experiment is actively looking for volunteers. It was first listed on October 3rd 2022 and its most recent update occurred on the 7th of that same month. Presently, 50 participants must be sourced from a single location."
Answered by AI
How many participants are currently invited to partake in this research?
"Affirmative, according to clinicaltrials.gov this investigation is still recruiting members since its posting on October 3rd 2022 and last edit date of October 7th 2022. The trial seeks 50 individuals at a single site."
Answered by AI
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