Pilot Study of TENS for Ocular Pain

Not Applicable

Completed

• Conditions: Eye Pain
• Interventions: Device: Active Cefaly Dual (R); Device: Sham Cefaly Dual (R)

• Registration Number: NCT05531643
• Lead Sponsor: VA Office of Research and Development

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-08-30
• Study First Submitted QC: 2022-09-02
• Study First Posted: 2022-09-08
• Study Start: 2022-10-03
• Primary Completion: 2024-11-30
• Study Completion: 2024-11-30
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-24
• Last Update Posted: 2025-01-27

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Active TENS	Active Cefaly Dual (R)	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.
Sham TENS	Sham Cefaly Dual (R)	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.

Primary Outcome Measures

Name	Time	Method
Screen failure rate	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	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)	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	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	1 year	Calculation of the percentage of individuals who complete at least 75% of treatment session.

Secondary Outcome Measures

Name	Time	Method
Rate of uncertainty in participant treatment allocation guess	1 year	Percentage of individuals who rate at least moderate uncertainty in guessing which treatment arm they were allocated to.
Percentage of individuals who score 100% on checklist for proper use of TENS device	1 year	The percentage of individuals who, after instruction, score 100% on checklist items for safe and proper use of the device.

Trial Locations

Locations (1)

Miami VA Healthcare System, Miami, FL; 🇺🇸 Miami, Florida, United States