Trial Outcomes & Findings for Microcurrent Device (TIVIC Health) (NCT NCT05198518)

Results Overview

Change in postoperative pain score in first use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the first time they use the device.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

60 participants

Primary outcome timeframe

baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure

Results posted on

2025-06-12

Participant Flow

60 patients met the inclusion criteria and enrolled into the study.

Participant milestones

Participant milestones
Measure	All Participants Screened Participants consented and had screening visit to determine eligibility	Microcurrent TENS Device A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region Microcurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.	Sham Device The sham device appears identical to the active device while emitting no therapeutic microcurrent. Sham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.
Screening Visit STARTED	118	0	0
Screening Visit COMPLETED	60	0	0
Screening Visit NOT COMPLETED	58	0	0
Enrolled Participants STARTED	0	27	33
Enrolled Participants COMPLETED	0	27	33
Enrolled Participants NOT COMPLETED	0	0	0

Reasons for withdrawal

Reasons for withdrawal
Measure	All Participants Screened Participants consented and had screening visit to determine eligibility	Microcurrent TENS Device A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region Microcurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.	Sham Device The sham device appears identical to the active device while emitting no therapeutic microcurrent. Sham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.
Screening Visit Deemed unable to participate	58	0	0

Baseline Characteristics

Microcurrent Device (TIVIC Health)

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Microcurrent TENS Device n=27 Participants A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region Microcurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.	Sham Device n=33 Participants The sham device appears identical to the active device while emitting no therapeutic microcurrent. Sham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.	Total n=60 Participants Total of all reporting groups
Age, Continuous	41.38 years STANDARD_DEVIATION 14.63 • n=99 Participants	39.55 years STANDARD_DEVIATION 14.31 • n=107 Participants	40.35 years STANDARD_DEVIATION 14.35 • n=206 Participants
Sex: Female, Male Female	10 Participants n=99 Participants	10 Participants n=107 Participants	20 Participants n=206 Participants
Sex: Female, Male Male	17 Participants n=99 Participants	23 Participants n=107 Participants	40 Participants n=206 Participants
Race/Ethnicity, Customized White (Caucasian)	19 Participants n=99 Participants	17 Participants n=107 Participants	36 Participants n=206 Participants
Race/Ethnicity, Customized Black or African American	4 Participants n=99 Participants	6 Participants n=107 Participants	10 Participants n=206 Participants
Race/Ethnicity, Customized Hispanic or Latino	2 Participants n=99 Participants	5 Participants n=107 Participants	7 Participants n=206 Participants
Race/Ethnicity, Customized Asian	0 Participants n=99 Participants	3 Participants n=107 Participants	3 Participants n=206 Participants
Race/Ethnicity, Customized Other	0 Participants n=99 Participants	1 Participants n=107 Participants	1 Participants n=206 Participants
Prior Sinus Surgery	25 Participants n=99 Participants	5 Participants n=107 Participants	30 Participants n=206 Participants
Pre-Operative Diagnosis Chronic Rhinosinusitis without Polyposis	16 Participants n=99 Participants	19 Participants n=107 Participants	35 Participants n=206 Participants
Pre-Operative Diagnosis Chronic Rhinosinusitis with Polyposis	8 Participants n=99 Participants	6 Participants n=107 Participants	14 Participants n=206 Participants
Pre-Operative Diagnosis Other	3 Participants n=99 Participants	8 Participants n=107 Participants	11 Participants n=206 Participants
Septoplasty	18 Participants n=99 Participants	22 Participants n=107 Participants	40 Participants n=206 Participants

PRIMARY outcome

Timeframe: baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure

Change in postoperative pain score in first use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the first time they use the device.

Outcome measures

Outcome measures
Measure	Microcurrent TENS Device n=27 Participants A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region Microcurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.	Sham Device n=33 Participants The sham device appears identical to the active device while emitting no therapeutic microcurrent. Sham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.
Change in Pain Visual Analog Score After First Use of Device Baseline	4.9 score on a scale Standard Deviation 2.06	5.6 score on a scale Standard Deviation 2.68
Change in Pain Visual Analog Score After First Use of Device 10 min	4.7 score on a scale Standard Deviation 1.96	4.8 score on a scale Standard Deviation 2.31
Change in Pain Visual Analog Score After First Use of Device 2 hour	4.0 score on a scale Standard Deviation 2.26	4.2 score on a scale Standard Deviation 2.33
Change in Pain Visual Analog Score After First Use of Device 4 hour	3.7 score on a scale Standard Deviation 2.47	3.9 score on a scale Standard Deviation 2.46

PRIMARY outcome

Timeframe: baseline, 10 min, 2 hour, 4 hour at second use within 14 days after procedure

Change in postoperative pain score after second use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the second time they use the device.

Outcome measures

Outcome measures
Measure	Microcurrent TENS Device n=27 Participants A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region Microcurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.	Sham Device n=33 Participants The sham device appears identical to the active device while emitting no therapeutic microcurrent. Sham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.
Change in Pain Visual Analog Score After Second Use of Device Baseline	4.4 score on a scale Standard Deviation 1.91	5.7 score on a scale Standard Deviation 2.99
Change in Pain Visual Analog Score After Second Use of Device 10 min	3.8 score on a scale Standard Deviation 1.60	5.0 score on a scale Standard Deviation 2.62
Change in Pain Visual Analog Score After Second Use of Device 2 hour	3.6 score on a scale Standard Deviation 1.66	4.5 score on a scale Standard Deviation 2.56
Change in Pain Visual Analog Score After Second Use of Device 4 hour	3.6 score on a scale Standard Deviation 1.66	4.2 score on a scale Standard Deviation 2.11

PRIMARY outcome

Timeframe: baseline, 10 min, 2 hour, 4 hour at 3rd use within 14 days after procedure

Change in postoperative pain score after third use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the third time they use the device.

Outcome measures

Outcome measures
Measure	Microcurrent TENS Device n=27 Participants A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region Microcurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.	Sham Device n=33 Participants The sham device appears identical to the active device while emitting no therapeutic microcurrent. Sham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.
Change in Pain Visual Analog Score After Third Use of Device Baseline	4.7 score on a scale Standard Deviation 2.20	4.6 score on a scale Standard Deviation 3.05
Change in Pain Visual Analog Score After Third Use of Device 10 min	4.3 score on a scale Standard Deviation 2.20	4.3 score on a scale Standard Deviation 2.47
Change in Pain Visual Analog Score After Third Use of Device 2 hour	3.6 score on a scale Standard Deviation 2.02	4.0 score on a scale Standard Deviation 1.84
Change in Pain Visual Analog Score After Third Use of Device 4 hour	3.7 score on a scale Standard Deviation 2.09	3.8 score on a scale Standard Deviation 2.07

PRIMARY outcome

Timeframe: baseline, 10 min, 2 hour, 4 hour at fourth use within 14 days after procedure

Change in postoperative pain score after fourth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fourth time they use the device.

Outcome measures

Outcome measures
Measure	Microcurrent TENS Device n=27 Participants A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region Microcurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.	Sham Device n=33 Participants The sham device appears identical to the active device while emitting no therapeutic microcurrent. Sham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.
Change in Pain Visual Analog Score After Fourth Use of Device Baseline	4.4 score on a scale Standard Deviation 2.06	4.1 score on a scale Standard Deviation 2.48
Change in Pain Visual Analog Score After Fourth Use of Device 10 min	3.6 score on a scale Standard Deviation 1.96	4.1 score on a scale Standard Deviation 2.35
Change in Pain Visual Analog Score After Fourth Use of Device 2 hour	3.3 score on a scale Standard Deviation 1.84	3.5 score on a scale Standard Deviation 2.15
Change in Pain Visual Analog Score After Fourth Use of Device 4 hour	3.1 score on a scale Standard Deviation 1.85	3.3 score on a scale Standard Deviation 2.22

PRIMARY outcome

Timeframe: baseline, 10 min, 2 hour, 4 hour at fifth use within 14 days after procedure

Change in postoperative pain score after fifth use of device post-op at different timepoints after intervention. Participants will record their pain score before and after use of the device. The pain will be recorded using a visual analog scale. Full scale from 0-10, with higher score indicating more pain. Participants instructed to use device for total of 14 days and recommended to use at least 3x a day. They are asked to record their pain levels at baseline, 10 min, 2 hours, and 4 hours after the fifth time they use the device.

Outcome measures

Outcome measures
Measure	Microcurrent TENS Device n=27 Participants A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region Microcurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.	Sham Device n=33 Participants The sham device appears identical to the active device while emitting no therapeutic microcurrent. Sham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.
Change in Pain Visual Analog Score After Fifth Use of Device Baseline	3.6 score on a scale Standard Deviation 1.71	4.1 score on a scale Standard Deviation 2.70
Change in Pain Visual Analog Score After Fifth Use of Device 10 min	3.3 score on a scale Standard Deviation 1.50	3.8 score on a scale Standard Deviation 2.48
Change in Pain Visual Analog Score After Fifth Use of Device 2 hour	3.4 score on a scale Standard Deviation 1.51	2.9 score on a scale Standard Deviation 2.02
Change in Pain Visual Analog Score After Fifth Use of Device 4 hour	2.9 score on a scale Standard Deviation 1.31	2.7 score on a scale Standard Deviation 2.28

PRIMARY outcome

Timeframe: Baseline and 2 weeks Post-Op

The possible range of Total SNOT scores is between 0 to 110. Higher scores indicate greater rhinosinusitis-related health burden.

Outcome measures

Outcome measures
Measure	Microcurrent TENS Device n=27 Participants A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region Microcurrent TENS device: The study device is a handheld micro-current TENS emitter intended to be used for the relief of postoperative pain after FESS. The design of the study device was optimized to provide transcutaneous nerve stimulation to the regional areas associated with the sinuses.	Sham Device n=33 Participants The sham device appears identical to the active device while emitting no therapeutic microcurrent. Sham Device: The sham device appears and operates identically to the active device, including indicator lights and haptic vibration, however it emits a weak direct current that is non-therapeutic.
Sino-Nasal Outcome Test (SNOT 22) Baseline	46.5 score on a scale Standard Deviation 21.4	37.6 score on a scale Standard Deviation 21.8
Sino-Nasal Outcome Test (SNOT 22) 2 weeks post-op	27.0 score on a scale Standard Deviation 17.5	19.2 score on a scale Standard Deviation 15.9

PRIMARY outcome

Timeframe: Baseline and 2 weeks Post-Op

Full scale from 0-100. Higher score indicates more severe symptoms