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Trial Outcomes & Findings for Pilot Study of TENS for Ocular Pain (NCT NCT05531643)

NCT ID: NCT05531643

Last Updated: 2026-06-10

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

39 participants

Primary outcome timeframe

6 months

Results posted on

2026-06-10

Participant Flow

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

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).

Participant milestones

Participant milestones
Measure
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.
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.
Overall Study
STARTED
24
13
Overall Study
COMPLETED
17
10
Overall Study
NOT COMPLETED
7
3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Pilot Study of TENS for Ocular Pain

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
High Frequency TENS
n=24 Participants
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
n=13 Participants
low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months.
Total
n=37 Participants
Total of all reporting groups
Age, Continuous
59 year
STANDARD_DEVIATION 9 • n=9 Participants
56 year
STANDARD_DEVIATION 16 • n=27 Participants
58 year
STANDARD_DEVIATION 12 • n=267 Participants
Sex: Female, Male
Female
12 Participants
n=9 Participants
7 Participants
n=27 Participants
19 Participants
n=267 Participants
Sex: Female, Male
Male
12 Participants
n=9 Participants
6 Participants
n=27 Participants
18 Participants
n=267 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Asian
1 Participants
n=9 Participants
0 Participants
n=27 Participants
1 Participants
n=267 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Black or African American
5 Participants
n=9 Participants
5 Participants
n=27 Participants
10 Participants
n=267 Participants
Race (NIH/OMB)
White
18 Participants
n=9 Participants
8 Participants
n=27 Participants
26 Participants
n=267 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
12 Participants
n=9 Participants
5 Participants
n=27 Participants
17 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
12 Participants
n=9 Participants
8 Participants
n=27 Participants
20 Participants
n=267 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=9 Participants
0 Participants
n=27 Participants
0 Participants
n=267 Participants

PRIMARY outcome

Timeframe: 6 months

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.

Outcome measures

Outcome measures
Measure
High Frequency TENS
n=24 Participants
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
n=13 Participants
low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months.
Reported Device-related Side-effects
# of people reporting
12 partcipants
10 partcipants
Reported Device-related Side-effects
# of people temporary discontinue device use
4 partcipants
2 partcipants

PRIMARY outcome

Timeframe: 6 months

Population: 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

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.

Outcome measures

Outcome measures
Measure
High Frequency TENS
n=14 Participants
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
n=12 Participants
low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months.
Time to Peak Change in Numerical Rating Scale (NRS, 0-10)
13 weeks after start of treatment
Interval 6.0 to 17.5
10 weeks after start of treatment
Interval 2.0 to 17.0

PRIMARY outcome

Timeframe: 6 months

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

Outcome measures

Outcome measures
Measure
High Frequency TENS
n=39 Participants
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
low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months.
Number of Screen Failures
2 Participants
—

PRIMARY outcome

Timeframe: 6 months

Population: 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

Count of the number (and calculated percentage) of individuals who reported completing at least 75% of treatment sessions.

Outcome measures

Outcome measures
Measure
High Frequency TENS
n=24 Participants
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
n=13 Participants
low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months.
Treatment Compliance Rate
6 Participants
5 Participants

SECONDARY outcome

Timeframe: baseline

The percentage of individuals who, after instruction, score 100% on checklist items for safe and proper use of the device.

Outcome measures

Outcome measures
Measure
High Frequency TENS
n=24 Participants
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
n=13 Participants
low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months.
Percentage of Individuals Who Score 100% on Checklist for Proper Use of TENS Device
24 Participants
13 Participants

SECONDARY outcome

Timeframe: 6 months

Population: 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

Percentage of individuals who rate at least moderate uncertainty in guessing which treatment arm they were allocated to.

Outcome measures

Outcome measures
Measure
High Frequency TENS
n=16 Participants
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
n=8 Participants
low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months.
Rate of Uncertainty in Participant Treatment Allocation Guess
10 Participants
7 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Exploratory regression analysis to identify associations between demographic variables and number of treatment sessions completed

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: 1 year

Exploratory regression analysis to identify associations between demographic variables and change in pain ratings (before vs. after 6 month TENS treatment)

Outcome measures

Outcome data not reported

Adverse Events

High Frequency TENS

Serious events: 0 serious events
Other events: 12 other events
Deaths: 0 deaths

Low Frequency TENS

Serious events: 0 serious events
Other events: 10 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure
High Frequency TENS
n=24 participants at risk
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
n=13 participants at risk
low frequency (3Hz) TENS delivered for 20 minutes to the forehead; at least 3 times per week in-home; for 6 months.
Skin and subcutaneous tissue disorders
skin rash
4.2%
1/24 • Number of events 3 • from initiation of first treatment session until the end of the six month intervention period
7.7%
1/13 • Number of events 1 • from initiation of first treatment session until the end of the six month intervention period
Nervous system disorders
forehead dysesthetic sensation
16.7%
4/24 • Number of events 4 • from initiation of first treatment session until the end of the six month intervention period
15.4%
2/13 • Number of events 2 • from initiation of first treatment session until the end of the six month intervention period
Nervous system disorders
headache
20.8%
5/24 • Number of events 8 • from initiation of first treatment session until the end of the six month intervention period
53.8%
7/13 • Number of events 15 • from initiation of first treatment session until the end of the six month intervention period
Nervous system disorders
ear dysesthetic sensations
8.3%
2/24 • Number of events 5 • from initiation of first treatment session until the end of the six month intervention period
0.00%
0/13 • from initiation of first treatment session until the end of the six month intervention period

Additional Information

Elizabeth R FElix

Miami VA Health Care System

Phone: 305-243-4497

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place