Pilot Study of TENS for Ocular Pain

NCT05531643 | Completed FDA Device

• 1 other identifier: F3883-P
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Eye Pain

Keywords

Eye pain; Dry Eye; Neuropathic Pain; Transcutaneous Electrical Nerve Stimulation

Outcome Measures

Primary Outcomes (5)

• Side-effect frequency and severity

  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.

  1 year

• Time to peak change in numerical rating scale (NRS, 0-10)

  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.

  1 year

• Enrollment rate

  Percentage of individuals who meet pre-screening requirements, are told about the study, and are consented and enrolled into the study

  1 year

• Screen failure rate

  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

  1 year

• Treatment compliance rate

  Calculation of the percentage of individuals who complete at least 75% of treatment session.

  1 year

Secondary Outcomes (2)

• Percentage of individuals who score 100% on checklist for proper use of TENS device

  1 year

• Rate of uncertainty in participant treatment allocation guess

  1 year

Other Outcomes (2)

• Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting adherence to treatment protocol

  1 year

• Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting change in pain (Numerical Rating Scale)

  1 year

Study Arms (2)

Active TENS

EXPERIMENTAL

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.

Device: Active Cefaly Dual (R)

Sham TENS

SHAM COMPARATOR

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.

Device: Sham Cefaly Dual (R)

Interventions

Active Cefaly Dual (R) DEVICE

Transcutaneous electrical nerve stimulation (TENS) device with electrode placement at the forehead. A biphasic rectangular wave will be delivered for a maximum of 20 minutes at a maximum amplitude of 16mA. Participant may halt amplitude before it reaches maximum amplitude. The device has previously been cleared by the FDA for use in migraine patients.

Active TENS

Sham Cefaly Dual (R) DEVICE

Transcutaneous electrical nerve stimulation (TENS) device with electrode placement at the forehead. A 1Hz wave will be delivered for 20 minutes at 1mA.

Sham TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

Miami VA Healthcare System, Miami, FL

Miami, Florida, 33125, United States

Location

MeSH Terms

Conditions

Eye Pain; Dry Eye Syndromes; Neuralgia

Condition Hierarchy (Ancestors)

Eye Manifestations; Eye Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Lacrimal Apparatus Diseases; Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases

Study Officials

• Elizabeth R Felix, PhD

  Miami VA Healthcare System, Miami, FL

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants and all study staff involved in participant evaluations will be blinded to treatment allocation. Each device will have the stimulation program pre-set according to the randomization assignment and be numbered. The randomization assignment will be held by the study statistician to match the device number to the intervention assignment. Devices will be distributed in numeric order according to the participant's chronologic order of enrollment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 30, 2022
• First Posted: September 8, 2022
• Study Start: October 3, 2022
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: January 27, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)