Chronic RhinosinusitisNCT05198518
Microcurrent Device (TIVIC Health)
A study testing Microcurrent TENS device in people with Chronic Rhinosinusitis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Rhinosinusitis
- What is being tested?
- Microcurrent TENS device
- Type of treatment
- Medical device
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Mar 2022to 4 Apr 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
Faculty Practice Associates - Mount Sinai Doctors
New York, New York, 10028
About this study
Official title: Utilization of a Microcurrent Device for Postoperative Pain Following Functional Endoscopic Sinus Surgery: a Randomized Controlled Trial
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.
- Conditions
- Chronic Rhinosinusitis
- Being tested
- Microcurrent TENS device, Sham Device
- Keywords
- chronic rhinosinusitis, postoperative pain, microcurrent
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microcurrent TENS deviceDevice
Also called Microcurrent neuromodulation 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 DeviceDevice
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 group | Role | What they receive |
|---|---|---|
| Microcurrent TENS device | Experimental | A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region Receives: Device: Microcurrent TENS device |
| Sham device | Sham comparator | The sham device appears identical to the active device while emitting no therapeutic microcurrent. Receives: Device: Sham Device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure
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.
Measured: baseline, 10 min, 2 hour, 4 hour at second use within 14 days after procedure
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.
Measured: baseline, 10 min, 2 hour, 4 hour at 3rd use within 14 days after procedure
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.
Measured: baseline, 10 min, 2 hour, 4 hour at fourth use within 14 days after procedure
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.
Measured: baseline, 10 min, 2 hour, 4 hour at fifth use within 14 days after procedure
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.
Measured: Baseline and 2 weeks Post-Op
Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score
Full scale from 0-100. Higher score indicates more severe symptoms
Measured: Baseline and 2 weeks Post-Op
Secondary outcomes (6)
Debridement Associated Pain Visual Analog Score Before 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 using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.
Measured: baseline, 10 min, 2 hour, 4 hour on POD14
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.
Measured: baseline, 10 min, 2 hour, 4 hour on POD14
Debridement Associated Pain Visual Analog Score After Second 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 second use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.
Measured: baseline, 10 min, 2 hour, 4 hour on POD14
Debridement Associated Pain Visual Analog Score After Third 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 third use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.
Measured: baseline, 10 min, 2 hour, 4 hour on POD14
Debridement Associated Pain Visual Analog Score After Fourth 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 fourth use of device using a visual analog scale. Full scale from 0-10, with higher score indicating more pain.
Measured: baseline, 10 min, 2 hour, 4 hour on POD14
Postoperative Pain Medication Usage
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
Measured: Daily until 2nd postoperative visit (day 14)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jan 2022
- Study start30 Mar 2022
- Primary completion19 Mar 2024
- Study completion4 Apr 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Chronic RhinosinusitisStudies of the same condition, open and under way.
- More trials run by Icahn School of Medicine at Mount SinaiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Icahn School of Medicine at Mount Sinai
- Sponsor type
- University, hospital or other
- Collaborators
- Tivic Health Systems
- Responsible party
- Principal investigator, Alfred-Marc Iloreta, Icahn School of Medicine at Mount Sinai
- Investigators
- Alfred-Marc Iloreta, MD, Principal investigator, Icahn School of Medicine at Mount Sinai
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05198518
- Sponsor's protocol ID
- STUDY-21-01392
- Status last verified
- May 2025
- First submitted
- 6 Jan 2022
- Last updated
- 12 Jun 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: No additional clinically relevant information will be collected from subjects in the course of the study beyond what is routinely collected and communicated to patients in their standard course of care. Study subjects will not be notified of results until the final analysis of study data is complete. The study results will be submitted for publication and/or presentation at national conferences/journals.
Study at a glance
From the registry record, last updated by the sponsor on 12 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Utilization of a Microcurrent Device for Postoperative Pain Following Functional Endoscopic Sinus Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT05198518
- Acronym / sponsor ID
- STUDY-21-01392
- Conditions
- Chronic Rhinosinusitis
- Keywords
- chronic rhinosinusitis, postoperative pain, microcurrent
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Icahn School of Medicine at Mount SinaiUniversity, hospital or other
- Collaborators
- Tivic Health Systems
- Study start
- 30 Mar 2022 (actual)
- Primary completion
- 19 Mar 2024 (actual)
- Study completion
- 4 Apr 2024 (actual)
- First posted
- 20 Jan 2022 (actual)
- Results
- Posted 12 Jun 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Microcurrent TENS device | Experimental | Device: Microcurrent TENS deviceA handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region |
| Sham device | Sham comparator | Device: Sham DeviceThe sham device appears identical to the active device while emitting no therapeutic microcurrent. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Microcurrent TENS deviceAlso: Microcurrent neuromodulation deviceThe 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. | Device | Microcurrent TENS device |
| Sham DeviceThe 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. | Device | Sham device |
Primary outcome
Change in Pain Visual Analog Score After First Use of Device
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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.
Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score
Time frame: Baseline and 2 weeks Post-Op
Full scale from 0-100. Higher score indicates more severe symptoms
6 secondary outcomes
Debridement Associated Pain Visual Analog Score Before Use of Device
Time frame: baseline, 10 min, 2 hour, 4 hour on POD14
Debridement Associated Pain Visual Analog Score After First Use of Device
Time frame: baseline, 10 min, 2 hour, 4 hour on POD14
Debridement Associated Pain Visual Analog Score After Second Use of Device
Time frame: baseline, 10 min, 2 hour, 4 hour on POD14
Debridement Associated Pain Visual Analog Score After Third Use of Device
Time frame: baseline, 10 min, 2 hour, 4 hour on POD14
Debridement Associated Pain Visual Analog Score After Fourth Use of Device
Time frame: baseline, 10 min, 2 hour, 4 hour on POD14
Postoperative Pain Medication Usage
Time frame: Daily until 2nd postoperative visit (day 14)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jun 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. No additional clinically relevant information will be collected from subjects in the course of the study beyond what is routinely collected and communicated to patients in their standard course of care. Study subjects will not be notified of results until the final analysis of study data is complete. The study results will be submitted for publication and/or presentation at national conferences/journals.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alfred-Marc Iloreta, MD principal investigator
Icahn School of Medicine at Mount Sinai
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Microcurrent TENS device in people with Chronic Rhinosinusitis, run by Icahn School of Medicine at Mount Sinai at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Jun 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pain Visual Analog Score After First Use of Device (time frame: baseline, 10 min, 2 hour, 4 hour at first use within 14 days after procedure). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jun 2025.