N/A
N=118
Microcurrent Device (TIVIC Health)
Chronic Rhinosinusitis
Bottom Line
View on ClinicalTrials.gov: NCT05198518 ↗Enrolled (actual)
118
Serious AEs
0.0%
Results posted
Jun 2025
Primary outcome: Primary: Change in Pain Visual Analog Score After First Use of Device — 4.9; 5.6; 4.7; 4.8 score on a scale
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Microcurrent TENS device (Device); Sham Device (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Icahn School of Medicine at Mount Sinai
- Primary completion
- Mar 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Pain Visual Analog Score After First Use of Device |
4.9; 5.6; 4.7; 4.8; 4.0; 4.2 | — |
| PRIMARY Change in Pain Visual Analog Score After Second Use of Device |
4.4; 5.7; 3.8; 5.0; 3.6; 4.5 | — |
| PRIMARY Change in Pain Visual Analog Score After Third Use of Device |
4.7; 4.6; 4.3; 4.3; 3.6; 4.0 | — |
| PRIMARY Change in Pain Visual Analog Score After Fourth Use of Device |
4.4; 4.1; 3.6; 4.1; 3.3; 3.5 | — |
| PRIMARY Change in Pain Visual Analog Score After Fifth Use of Device |
3.6; 4.1; 3.3; 3.8; 3.4; 2.9 | — |
| PRIMARY Sino-Nasal Outcome Test (SNOT 22) |
46.5; 37.6; 27.0; 19.2 | — |
| PRIMARY Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score |
3.8; 3.8 | — |
| SECONDARY Debridement Associated Pain Visual Analog Score Before Use of Device |
4.88; 5.6; 4.71; 4.8; 4; 4.2 | — |
| SECONDARY Debridement Associated Pain Visual Analog Score After First Use of Device |
4.47; 5.67; 3.76; 5; 3.59; 4.53 | — |
| SECONDARY Debridement Associated Pain Visual Analog Score After Second Use of Device |
4.71; 4.6; 4.29; 4.25; 1.82; 2.02 | — |
| SECONDARY Debridement Associated Pain Visual Analog Score After Third Use of Device |
4.4; 4.06; 3.6; 4.11; 3.33; 3.5 | — |
| SECONDARY Debridement Associated Pain Visual Analog Score After Fourth Use of Device |
3.75; 4.13; 3.33; 3.8; 3.41; 2.93 | — |
| SECONDARY Postoperative Pain Medication Usage |
24.3; 16.4; 2.5; 1.5 | — |
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.
Eligibility Criteria
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)
Data sourced from ClinicalTrials.gov (NCT05198518). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.