Pilot Study of TENS for Ocular Pain

Eye Pain Clinical Trial

Official title:

A Pilot Study of the Safety and Feasibility of Transcutaneous Electrical Nerve Stimulation (TENS) for Chronic Ocular Pain

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05531643
• Other study ID #: F3883-P
• Status: Recruiting
• Phase: N/A
• Start date: October 3, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: September 2023
• Source: VA Office of Research and Development
• Contact: Elizabeth R Felix, PhD
• Phone: (305) 243-4497
• Email: Elizabeth.Felix2[@]va.gov
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Eye Pain

Intervention

Device:
• Active Cefaly Dual (R)
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.
• Sham Cefaly Dual (R)
Transcutaneous electrical nerve stimulation (TENS) device with electrode placement at the forehead. A 1Hz wave will be delivered for 20 minutes at 1mA.

Locations

Country	Name	City	State
United States	Miami VA Healthcare System, Miami, FL	Miami	Florida

Sponsors (1)

Lead Sponsor	Collaborator
VA Office of Research and Development

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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
Other	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)	1 year
Primary	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
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.	1 year
Primary	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
Primary	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
Primary	Treatment compliance rate	Calculation of the percentage of individuals who complete at least 75% of treatment session.	1 year
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.	1 year
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.	1 year