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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| high frequency TENS | Experimental | high frequency (60Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months. |
|
| low frequency TENS | Active Comparator | low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| High frequency forehead TENS | Device | Transcutaneous electrical nerve stimulation (TENS) device with electrode placement at the forehead. Biphasic rectangular impulses at 60Hz frequency 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Reported Device-related Side-effects | An open-ended question 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. Presence, description of symptom, severity of symptoms, participant assessment of device/treatment-relatedness of symptoms, and desire or actual discontinuation of device use will be recorded. | 6 months |
| 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. | 6 months |
| Number of Screen Failures | The number of individuals who meet pre-screening requirements, consent to study procedures, but who do not meet full criteria after screening visit is conducted | 6 months |
| Treatment Compliance Rate | Count of the number (and calculated percentage) of individuals who reported completing at least 75% of treatment sessions. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | baseline |
| Rate of Uncertainty in Participant Treatment Allocation Guess |
| Measure | Description | Time Frame |
|---|---|---|
| Beta Coefficients for Participant Demographics (Sex, Age, Race/Ethnicity) in Regression Model Predicting Adherence to Treatment Protocol | Exploratory regression analysis to identify associations between demographic variables and number of treatment sessions completed | 1 year |
| Beta Coefficients for Participant Demographics (Sex, Age, Race/Ethnicity) in Regression Model Predicting Change in Pain (Numerical Rating Scale) |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Elizabeth R Felix, PhD | Miami VA Healthcare System, Miami, FL | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Miami VA Healthcare System, Miami, FL | Miami | Florida | 33125 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 41812852 | Derived | Shields C, Qazi S, Zaldivar A, Cabrera K, Mangwani-Mordani S, Peterson H, Bhatt S, Tang F, Galor A, Felix ER. Randomized Pilot Study of Transcutaneous Electrical Nerve Stimulation for Neuropathic/Nociplastic Ocular Pain. Am J Ophthalmol. 2026 Jun;286:318-331. doi: 10.1016/j.ajo.2026.03.008. Epub 2026 Mar 10. |
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Two participants screened out after consent. Thus 37 participants were randomized to treatment. (Some outcome measures (e.g., number of screen failures) are based on the total number of enrolled participants (39); while other outcomes are based on the number of individuals assigned to treatment (37).
enrollment includes all individuals who signed the informed consent form with intent to complete the study and who attended the initiating/baseline visit of the study
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| ID | Title | Description |
|---|---|---|
| FG000 | High Frequency TENS | high frequency (60Hz) 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. |
| FG001 | Low Frequency TENS | low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | High Frequency TENS | high frequency (60Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months. |
| BG001 | Low Frequency TENS | low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Reported Device-related Side-effects | An open-ended question 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. Presence, description of symptom, severity of symptoms, participant assessment of device/treatment-relatedness of symptoms, and desire or actual discontinuation of device use will be recorded. | Posted | Number | partcipants | 6 months |
|
from initiation of first treatment session until the end of the six month intervention period
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | High Frequency TENS | high frequency (60Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment | related to electrode material |
This was a pilot investigation, primarily targeted to determine what methodology changes might be needed to ensure feasibility for a fully-powered clinical trial of TENS for chronic ocular pain. As such, many limitations are present within the results, and all reported information should be interpreted with caution.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Elizabeth R FElix | Miami VA Health Care System | 305-243-4497 | elizabeth.felix2@va.gov |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 18, 2022 | Nov 27, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Feb 2, 2024 | Sep 9, 2024 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D058447 | Eye Pain |
| D015352 | Dry Eye Syndromes |
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D005132 | Eye Manifestations |
| D005128 | Eye Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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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.
|
| Low frequency forehead TENS | Device | Transcutaneous electrical nerve stimulation (TENS) device with electrode placement at the forehead. A 3Hz biphasic square wave will be delivered for 20 minutes up to a maximum amplitude of 16mA. |
|
Percentage of individuals who rate at least moderate uncertainty in guessing which treatment arm they were allocated to. |
| 6 months |
Exploratory regression analysis to identify associations between demographic variables and change in pain ratings (before vs. after 6 month TENS treatment) |
| 1 year |
| BG002 | Total | Total of all reporting groups |
| year |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
|
|
| Primary | 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. | Calculation to peak reduction was only made for those who had at least a 1pt reduction in pain on the 0-10 NRS from baseline at at least one time point after baseline | Posted | Median | Inter-Quartile Range | weeks after start of treatment | 6 months |
|
|
|
| Primary | Number of Screen Failures | The number of individuals who meet pre-screening requirements, consent to study procedures, but who do not meet full criteria after screening visit is conducted | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Primary | Treatment Compliance Rate | Count of the number (and calculated percentage) of individuals who reported completing at least 75% of treatment sessions. | Calculated based on all participants who were assigned to a treatment group - how many completed at least 75% of sessions based on self-report across the 6 month intervention period | Posted | Count of Participants | Participants | 6 months |
|
|
|
| Secondary | 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. | Posted | Count of Participants | Participants | baseline |
|
|
|
| Secondary | 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. | The number of participant data points available for analysis of this outcome was 16 in the hfTENS group and 8 in the lfTENS group, due to missing data/loss to follow-up | Posted | Count of Participants | Participants | 6 months |
|
|
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| Other Pre-specified | Beta Coefficients for Participant Demographics (Sex, Age, Race/Ethnicity) in Regression Model Predicting Adherence to Treatment Protocol | Exploratory regression analysis to identify associations between demographic variables and number of treatment sessions completed | Not Posted | 1 year | Participants |
| Other Pre-specified | Beta Coefficients for Participant Demographics (Sex, Age, Race/Ethnicity) in Regression Model Predicting Change in Pain (Numerical Rating Scale) | Exploratory regression analysis to identify associations between demographic variables and change in pain ratings (before vs. after 6 month TENS treatment) | Not Posted | 1 year | Participants |
| 0 |
| 24 |
| 0 |
| 24 |
| 12 |
| 24 |
| EG001 | Low Frequency TENS | low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months. | 0 | 13 | 0 | 13 | 10 | 13 |
|
| forehead dysesthetic sensation | Nervous system disorders | Systematic Assessment | expected sensory experience related to stimulation |
|
| headache | Nervous system disorders | Systematic Assessment | reported as related to intervention |
|
| ear dysesthetic sensations | Nervous system disorders | Systematic Assessment |
|
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| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D007766 | Lacrimal Apparatus Diseases |
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |