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Completed

NCT Number: NCT05198518

Microcurrent Device (TIVIC Health)

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.

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Key information

Conditions

Chronic Rhinosinusitis Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Faculty Practice Associates - Mount Sinai Doctors

New York, 10028, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Microcurrent TENS device

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.

Other names: Microcurrent neuromodulation device

Sham device

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.

Primary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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

Secondary outcomes

  1. Debridement Associated Pain Visual Analog Score Before Use of Device

    Time frame: 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.

  2. Debridement Associated Pain Visual Analog Score After First Use of Device

    Time frame: 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.

  3. Debridement Associated Pain Visual Analog Score After Second Use of Device

    Time frame: 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.

  4. Debridement Associated Pain Visual Analog Score After Third Use of Device

    Time frame: 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.

  5. Debridement Associated Pain Visual Analog Score After Fourth Use of Device

    Time frame: 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.

  6. Postoperative Pain Medication Usage

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Icahn School of Medicine at Mount Sinai

Other

Collaborators

  • Tivic Health Systems

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jan 20, 2022
Registry last updated
Jun 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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