Microcurrent Device (TIVIC Health)

Utilization of a Microcurrent Device for Postoperative Pain Following Functional Endoscopic Sinus Surgery: a Randomized Controlled Trial

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05198518

Enrollment

Registered

2022-01-20

Start date

2022-03-30

Completion date

2024-04-04

Last updated

2025-06-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Rhinosinusitis

Keywords

chronic rhinosinusitis, postoperative pain, microcurrent

Brief summary

The purpose of this study is to investigate whether daily use of a microcurrent neuromodulation device, which applies a small current of electricity to the forehead and maxillary region, will decrease the pain experienced by patients in the days following functional endoscopic sinus surgery (FESS). This study is a prospective randomized controlled study. Enrolled subjects will be randomized (1:1) to receive either an active neuromodulation study device or a sham device that appears identical to the active device while emitting no therapeutic microcurrent. Subjects will self-treat with the device at home and will be followed for 2 weeks after FESS.

Interventions

DEVICEMicrocurrent 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.

DEVICESham 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

The participant and all study staff will be blinded to which device they are receiving, either the study device or the identical sham device. Devices will be labeled A or B, with only the device manufacturer knowing which device is the active study device and which is the sham.

Intervention model description

Subjects will be randomly assigned in a 1:1 ratio to receive the intervention or placebo. Randomization will be completed via a computer-generated randomization table.

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* Scheduled for FESS functional nasal or endoscopic sinus surgery * Possessing an American Society of Anesthesiologists physical status classification of I or II * Age ≥ 18 * Possess the capacity to give informed consent * Able to read, write and understand English or Spanish * Able to attend follow up visits at postop days 7 and 14 Visit 1 (within 0 - day 14) and post-op Visit 2 (within 10 - 21 days) * Postop pain VAS ≥ 5 in PACU phase II

Exclusion criteria

* Age \< 18 * Does not understand English or Spanish * Does not meet inclusion criteria * History of chronic pain * Experiencing chronic pain requiring opioids at baseline and/or who are under the care of pain management specialists * Neurologic disorders (including seizure disorders) * Undergoing planned or unplanned additional procedures at the time of FESS surgery * In custody of the state * Prisoners * Known to be pregnant * Implanted cranial metallic components or devices including deep brain stimulators or cochlear implants * Has an implanted or external worn cardiac device including pacemakers, automated implantable cardioverter defibrillator (AICD), or any other cardiac electric devices (including non-implanted devices, e.g. defibrillator vest)

Design outcomes

Primary

Measure	Time frame	Description
Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score	Baseline and 2 weeks Post-Op	Full scale from 0-100. Higher score indicates more severe symptoms
Change in Pain Visual Analog Score After First Use of Device	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.
Change in Pain Visual Analog Score After Second Use of Device	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.
Change in Pain Visual Analog Score After Third Use of Device	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.
Change in Pain Visual Analog Score After Fourth Use of Device	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.
Change in Pain Visual Analog Score After Fifth Use of Device	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.
Sino-Nasal Outcome Test (SNOT 22)	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.

Secondary

Measure	Time frame	Description
Debridement Associated Pain Visual Analog Score After First Use of Device	baseline, 10 min, 2 hour, 4 hour on POD14	Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the first use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.
Debridement Associated Pain Visual Analog Score After Second Use of Device	baseline, 10 min, 2 hour, 4 hour on POD14	Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the second use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.
Debridement Associated Pain Visual Analog Score After Third Use of Device	baseline, 10 min, 2 hour, 4 hour on POD14	Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the third use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.
Debridement Associated Pain Visual Analog Score After Fourth Use of Device	baseline, 10 min, 2 hour, 4 hour on POD14	Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the fourth use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.
Postoperative Pain Medication Usage	Daily until 2nd postoperative visit (day 14)	Participants will record their postoperative pain medication daily usage (opioids and acetaminophen). Number of Acetaminophen 325mg or Number of Oxycodone 5 mg taken across 2 weeks post-op
Debridement Associated Pain Visual Analog Score Before Use of Device	baseline, 10 min, 2 hour, 4 hour on POD14	Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.

Countries

United States

Participant flow

Recruitment details

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

Participants by arm

Arm	Count
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.	27
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.	33
Total	60

Withdrawals & dropouts

Period	Reason	FG000	FG001	FG002
Screening Visit	Deemed unable to participate	58	0	0

Baseline characteristics

Characteristic	Sham Device	Microcurrent TENS Device	Total
Age, Continuous	39.55 years STANDARD_DEVIATION 14.31	41.38 years STANDARD_DEVIATION 14.63	40.35 years STANDARD_DEVIATION 14.35
Pre-Operative Diagnosis Chronic Rhinosinusitis without Polyposis	19 Participants	16 Participants	35 Participants
Pre-Operative Diagnosis Chronic Rhinosinusitis with Polyposis	6 Participants	8 Participants	14 Participants
Pre-Operative Diagnosis Other	8 Participants	3 Participants	11 Participants
Prior Sinus Surgery	5 Participants	25 Participants	30 Participants
Race/Ethnicity, Customized Asian	3 Participants	0 Participants	3 Participants
Race/Ethnicity, Customized Black or African American	6 Participants	4 Participants	10 Participants
Race/Ethnicity, Customized Hispanic or Latino	5 Participants	2 Participants	7 Participants
Race/Ethnicity, Customized Other	1 Participants	0 Participants	1 Participants
Race/Ethnicity, Customized White (Caucasian)	17 Participants	19 Participants	36 Participants
Septoplasty	22 Participants	18 Participants	40 Participants
Sex: Female, Male Female	10 Participants	10 Participants	20 Participants
Sex: Female, Male Male	23 Participants	17 Participants	40 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 27	0 / 33
other Total, other adverse events	0 / 27	0 / 33
serious Total, serious adverse events	0 / 27	0 / 33

Outcome results

Primary

Change in Pain Visual Analog Score After Fifth Use of Device

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Microcurrent TENS Device	Change in Pain Visual Analog Score After Fifth Use of Device	Baseline	3.6 score on a scale	Standard Deviation 1.71
Microcurrent TENS Device	Change in Pain Visual Analog Score After Fifth Use of Device	10 min	3.3 score on a scale	Standard Deviation 1.5
Microcurrent TENS Device	Change in Pain Visual Analog Score After Fifth Use of Device	2 hour	3.4 score on a scale	Standard Deviation 1.51
Microcurrent TENS Device	Change in Pain Visual Analog Score After Fifth Use of Device	4 hour	2.9 score on a scale	Standard Deviation 1.31
Sham Device	Change in Pain Visual Analog Score After Fifth Use of Device	4 hour	2.7 score on a scale	Standard Deviation 2.28
Sham Device	Change in Pain Visual Analog Score After Fifth Use of Device	Baseline	4.1 score on a scale	Standard Deviation 2.7
Sham Device	Change in Pain Visual Analog Score After Fifth Use of Device	2 hour	2.9 score on a scale	Standard Deviation 2.02
Sham Device	Change in Pain Visual Analog Score After Fifth Use of Device	10 min	3.8 score on a scale	Standard Deviation 2.48

Primary

Change in Pain Visual Analog Score After First Use of Device

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Microcurrent TENS Device	Change in Pain Visual Analog Score After First Use of Device	Baseline	4.9 score on a scale	Standard Deviation 2.06
Microcurrent TENS Device	Change in Pain Visual Analog Score After First Use of Device	10 min	4.7 score on a scale	Standard Deviation 1.96
Microcurrent TENS Device	Change in Pain Visual Analog Score After First Use of Device	2 hour	4.0 score on a scale	Standard Deviation 2.26
Microcurrent TENS Device	Change in Pain Visual Analog Score After First Use of Device	4 hour	3.7 score on a scale	Standard Deviation 2.47
Sham Device	Change in Pain Visual Analog Score After First Use of Device	4 hour	3.9 score on a scale	Standard Deviation 2.46
Sham Device	Change in Pain Visual Analog Score After First Use of Device	Baseline	5.6 score on a scale	Standard Deviation 2.68
Sham Device	Change in Pain Visual Analog Score After First Use of Device	2 hour	4.2 score on a scale	Standard Deviation 2.33
Sham Device	Change in Pain Visual Analog Score After First Use of Device	10 min	4.8 score on a scale	Standard Deviation 2.31

Primary

Change in Pain Visual Analog Score After Fourth Use of Device

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Microcurrent TENS Device	Change in Pain Visual Analog Score After Fourth Use of Device	Baseline	4.4 score on a scale	Standard Deviation 2.06
Microcurrent TENS Device	Change in Pain Visual Analog Score After Fourth Use of Device	10 min	3.6 score on a scale	Standard Deviation 1.96
Microcurrent TENS Device	Change in Pain Visual Analog Score After Fourth Use of Device	2 hour	3.3 score on a scale	Standard Deviation 1.84
Microcurrent TENS Device	Change in Pain Visual Analog Score After Fourth Use of Device	4 hour	3.1 score on a scale	Standard Deviation 1.85
Sham Device	Change in Pain Visual Analog Score After Fourth Use of Device	4 hour	3.3 score on a scale	Standard Deviation 2.22
Sham Device	Change in Pain Visual Analog Score After Fourth Use of Device	Baseline	4.1 score on a scale	Standard Deviation 2.48
Sham Device	Change in Pain Visual Analog Score After Fourth Use of Device	2 hour	3.5 score on a scale	Standard Deviation 2.15
Sham Device	Change in Pain Visual Analog Score After Fourth Use of Device	10 min	4.1 score on a scale	Standard Deviation 2.35

Primary

Change in Pain Visual Analog Score After Second Use of Device

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Microcurrent TENS Device	Change in Pain Visual Analog Score After Second Use of Device	Baseline	4.4 score on a scale	Standard Deviation 1.91
Microcurrent TENS Device	Change in Pain Visual Analog Score After Second Use of Device	10 min	3.8 score on a scale	Standard Deviation 1.6
Microcurrent TENS Device	Change in Pain Visual Analog Score After Second Use of Device	2 hour	3.6 score on a scale	Standard Deviation 1.66
Microcurrent TENS Device	Change in Pain Visual Analog Score After Second Use of Device	4 hour	3.6 score on a scale	Standard Deviation 1.66
Sham Device	Change in Pain Visual Analog Score After Second Use of Device	4 hour	4.2 score on a scale	Standard Deviation 2.11
Sham Device	Change in Pain Visual Analog Score After Second Use of Device	Baseline	5.7 score on a scale	Standard Deviation 2.99
Sham Device	Change in Pain Visual Analog Score After Second Use of Device	2 hour	4.5 score on a scale	Standard Deviation 2.56
Sham Device	Change in Pain Visual Analog Score After Second Use of Device	10 min	5.0 score on a scale	Standard Deviation 2.62

Primary

Change in Pain Visual Analog Score After Third Use of Device

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.

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

Arm	Measure	Group	Value (MEAN)	Dispersion
Microcurrent TENS Device	Change in Pain Visual Analog Score After Third Use of Device	2 hour	3.6 score on a scale	Standard Deviation 2.02
Microcurrent TENS Device	Change in Pain Visual Analog Score After Third Use of Device	10 min	4.3 score on a scale	Standard Deviation 2.2
Microcurrent TENS Device	Change in Pain Visual Analog Score After Third Use of Device	4 hour	3.7 score on a scale	Standard Deviation 2.09
Microcurrent TENS Device	Change in Pain Visual Analog Score After Third Use of Device	Baseline	4.7 score on a scale	Standard Deviation 2.2
Sham Device	Change in Pain Visual Analog Score After Third Use of Device	4 hour	3.8 score on a scale	Standard Deviation 2.07
Sham Device	Change in Pain Visual Analog Score After Third Use of Device	10 min	4.3 score on a scale	Standard Deviation 2.47
Sham Device	Change in Pain Visual Analog Score After Third Use of Device	2 hour	4.0 score on a scale	Standard Deviation 1.84
Sham Device	Change in Pain Visual Analog Score After Third Use of Device	Baseline	4.6 score on a scale	Standard Deviation 3.05

Primary

Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score

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

Time frame: Baseline and 2 weeks Post-Op

Arm	Measure	Value (MEAN)	Dispersion
Microcurrent TENS Device	Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score	3.8 mean difference in score on a scale	Standard Deviation 4.8
Sham Device	Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score	3.8 mean difference in score on a scale	Standard Deviation 7.4

Primary

Sino-Nasal Outcome Test (SNOT 22)

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

Time frame: Baseline and 2 weeks Post-Op

Arm	Measure	Group	Value (MEAN)	Dispersion
Microcurrent TENS Device	Sino-Nasal Outcome Test (SNOT 22)	2 weeks post-op	27.0 score on a scale	Standard Deviation 17.5
Microcurrent TENS Device	Sino-Nasal Outcome Test (SNOT 22)	Baseline	46.5 score on a scale	Standard Deviation 21.4
Sham Device	Sino-Nasal Outcome Test (SNOT 22)	Baseline	37.6 score on a scale	Standard Deviation 21.8
Sham Device	Sino-Nasal Outcome Test (SNOT 22)	2 weeks post-op	19.2 score on a scale	Standard Deviation 15.9

Secondary

Debridement Associated Pain Visual Analog Score After First Use of Device

Participants will record their pain before using the device at their postoperative debridement visits on post operative day 14 (POD14). Their pain levels will be recorded at baseline, 10 min, 2 hours, and 4 hours after the first use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.