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Pilot Study of TENS for Ocular Pain

Primary Purpose

Eye Pain

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Active Cefaly Dual (R)
Sham Cefaly Dual (R)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eye Pain focused on measuring Eye pain, Dry Eye, Neuropathic Pain, Transcutaneous Electrical Nerve Stimulation

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  • na�ve 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

Sites / Locations

  • Miami VA Healthcare System, Miami, FLRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Active TENS

Sham TENS

Arm Description

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 delivered for 20 minutes to the forehead via the sham Cefaly (R) device; at least 3 times per week in-home; for 6 months.

Outcomes

Primary Outcome Measures

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.
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.
Enrollment rate
Percentage of individuals who meet pre-screening requirements, are told about the study, and are consented and enrolled into the study
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
Treatment compliance rate
Calculation of the percentage of individuals who complete at least 75% of treatment session.

Secondary Outcome Measures

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

Full Information

First Posted
August 30, 2022
Last Updated
September 8, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT05531643
Brief Title
Pilot Study of TENS for Ocular Pain
Official Title
A Pilot Study of the Safety and Feasibility of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Ocular Pain
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 3, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eye Pain
Keywords
Eye pain, Dry Eye, Neuropathic Pain, Transcutaneous Electrical Nerve Stimulation

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Active TENS
Arm Type
Experimental
Arm Description
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.
Arm Title
Sham TENS
Arm Type
Sham Comparator
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
Active Cefaly Dual (R)
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Sham Cefaly Dual (R)
Intervention Description
Transcutaneous electrical nerve stimulation (TENS) device with electrode placement at the forehead. A 1Hz wave will be delivered for 20 minutes at 1mA.
Primary Outcome Measure Information:
Title
Side-effect frequency and severity
Description
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 Frame
1 year
Title
Time to peak change in numerical rating scale (NRS, 0-10)
Description
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.
Time Frame
1 year
Title
Enrollment rate
Description
Percentage of individuals who meet pre-screening requirements, are told about the study, and are consented and enrolled into the study
Time Frame
1 year
Title
Screen failure rate
Description
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
Time Frame
1 year
Title
Treatment compliance rate
Description
Calculation of the percentage of individuals who complete at least 75% of treatment session.
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Percentage of individuals who score 100% on checklist for proper use of TENS device
Description
The percentage of individuals who, after instruction, score 100% on checklist items for safe and proper use of the device.
Time Frame
1 year
Title
Rate of uncertainty in participant treatment allocation guess
Description
Percentage of individuals who rate at least moderate uncertainty in guessing which treatment arm they were allocated to.
Time Frame
1 year
Other Pre-specified Outcome Measures:
Title
Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting adherence to treatment protocol
Description
Exploratory regression analysis to identify associations between demographic variables and number of treatment sessions completed
Time Frame
1 year
Title
Beta coefficients for participant demographics (sex, age, race/ethnicity) in regression model predicting change in pain (Numerical Rating Scale)
Description
Exploratory regression analysis to identify associations between demographic variables and change in pain ratings (before vs. after 6 month TENS treatment)
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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 na�ve 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Elizabeth R Felix, PhD
Phone
(305) 243-4497
Email
Elizabeth.Felix2@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Anat Galor, MD MSPH
Phone
(305) 450-6050
Email
Anat.Galor@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elizabeth R Felix, PhD
Organizational Affiliation
Miami VA Healthcare System, Miami, FL
Official's Role
Principal Investigator
Facility Information:
Facility Name
Miami VA Healthcare System, Miami, FL
City
Miami
State/Province
Florida
ZIP/Postal Code
33125
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Luis A Gonzalez, MHA
Phone
305-575-3179
Email
Luis.Gonzalez2@va.gov
First Name & Middle Initial & Last Name & Degree
Minh Tran, PhD
Phone
(305) 575-7743
Email
Minh.Tran@va.gov
First Name & Middle Initial & Last Name & Degree
Elizabeth R Felix, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Pilot Study of TENS for Ocular Pain

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