An interventional study of Microcurrent TENS device and Sham Device in Chronic Rhinosinusitis, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-06-12.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
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.
330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.
This study's enrollment of 60 is close to the median of 60 across 227 interventional studies indexed under Rhinosinusitis.
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Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
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Exclusion Criteria:
A handheld micro-current TENS emitter device, which applies a small current of electricity to the forehead and maxillary region
Device: Microcurrent TENS device
The sham device appears identical to the active device while emitting no therapeutic microcurrent.
Device: Sham 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.
Also known as: Microcurrent neuromodulation 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
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
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
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
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
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
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
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
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: Daily until 2nd postoperative visit (day 14)
60 patients met the inclusion criteria and enrolled into the study.
| Milestone | All Participants Screened | Microcurrent TENS Device | Sham Device |
|---|---|---|---|
| Started | 118 | 0 | 0 |
| Completed | 60 | 0 | 0 |
| Not completed | 58 | 0 | 0 |
| Withdrew: Deemed unable to participate | 58 | 0 | 0 |
| Milestone | All Participants Screened | Microcurrent TENS Device | Sham Device |
|---|---|---|---|
| Started | 0 | 27 | 33 |
| Completed | 0 | 27 | 33 |
| Not completed | 0 | 0 | 0 |
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.
| score on a scale | Microcurrent TENS Device | Sham Device |
|---|---|---|
| Baseline | 4.9 ± 2.06 | 5.6 ± 2.68 |
| 10 min | 4.7 ± 1.96 | 4.8 ± 2.31 |
| 2 hour | 4.0 ± 2.26 | 4.2 ± 2.33 |
| 4 hour | 3.7 ± 2.47 | 3.9 ± 2.46 |
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.
| score on a scale | Microcurrent TENS Device | Sham Device |
|---|---|---|
| Baseline | 4.4 ± 1.91 | 5.7 ± 2.99 |
| 10 min | 3.8 ± 1.60 | 5.0 ± 2.62 |
| 2 hour | 3.6 ± 1.66 | 4.5 ± 2.56 |
| 4 hour | 3.6 ± 1.66 | 4.2 ± 2.11 |
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.
| score on a scale | Microcurrent TENS Device | Sham Device |
|---|---|---|
| Baseline | 4.7 ± 2.20 | 4.6 ± 3.05 |
| 10 min | 4.3 ± 2.20 | 4.3 ± 2.47 |
| 2 hour | 3.6 ± 2.02 | 4.0 ± 1.84 |
| 4 hour | 3.7 ± 2.09 | 3.8 ± 2.07 |
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.
| score on a scale | Microcurrent TENS Device | Sham Device |
|---|---|---|
| Baseline | 4.4 ± 2.06 | 4.1 ± 2.48 |
| 10 min | 3.6 ± 1.96 | 4.1 ± 2.35 |
| 2 hour | 3.3 ± 1.84 | 3.5 ± 2.15 |
| 4 hour | 3.1 ± 1.85 | 3.3 ± 2.22 |
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.
| score on a scale | Microcurrent TENS Device | Sham Device |
|---|---|---|
| Baseline | 3.6 ± 1.71 | 4.1 ± 2.70 |
| 10 min | 3.3 ± 1.50 | 3.8 ± 2.48 |
| 2 hour | 3.4 ± 1.51 | 2.9 ± 2.02 |
| 4 hour | 2.9 ± 1.31 | 2.7 ± 2.28 |
The possible range of Total SNOT scores is between 0 to 110. Higher scores indicate greater rhinosinusitis-related health burden.
| score on a scale | Microcurrent TENS Device | Sham Device |
|---|---|---|
| Baseline | 46.5 ± 21.4 | 37.6 ± 21.8 |
| 2 weeks post-op | 27.0 ± 17.5 | 19.2 ± 15.9 |
Full scale from 0-100. Higher score indicates more severe symptoms
| mean difference in score on a scale | Microcurrent TENS Device | Sham Device |
|---|---|---|
| Mean Difference in Nasal Obstruction Symptom Evaluation (NOSE) Score | 3.8 ± 4.8 | 3.8 ± 7.4 |
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.
| score on a scale | Microcurrent TENS Device | Sham Device |
|---|---|---|
| Baseline | 4.88 ± 2.06 | 5.6 ± 2.68 |
| 10 min | 4.71 ± 1.96 | 4.8 ± 2.31 |
| 2 hour | 4 ± 2.26 | 4.2 ± 2.33 |
| 4 hour | 3.71 ± 2.47 | 3.85 ± 2.46 |
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.
| score on a scale | Microcurrent TENS Device | Sham Device |
|---|---|---|
| Baseline | 4.47 ± 1.91 | 5.67 ± 2.99 |
| 10 min | 3.76 ± 1.6 | 5 ± 2.62 |
| 2 hour | 3.59 ± 1.66 | 4.53 ± 2.56 |
| 4 hour | 3.59 ± 1.66 | 4.2 ± 2.11 |
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.
| score on a scale | Microcurrent TENS Device | Sham Device |
|---|---|---|
| Baseline | 4.71 ± 2.2 | 4.6 ± 3.05 |
| 10 min | 4.29 ± 2.2 | 4.25 ± 2.47 |
| 2 hour | 1.82 ± 3.64 | 2.02 ± 4 |
| 4 hour | 3.71 ± 2.09 | 3.8 ± 2.07 |
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.
| score on a scale | Microcurrent TENS Device | Sham Device |
|---|---|---|
| Baseline | 4.4 ± 2.06 | 4.06 ± 2.48 |
| 10 min | 3.6 ± 1.96 | 4.11 ± 2.35 |
| 2 hour | 3.33 ± 1.84 | 3.5 ± 2.15 |
| 4 hour | 3.13 ± 1.85 | 3.33 ± 2.22 |
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.
| score on a scale | Microcurrent TENS Device | Sham Device |
|---|---|---|
| Baseline | 3.75 ± 1.71 | 4.13 ± 2.7 |
| 10 min | 3.33 ± 1.5 | 3.8 ± 2.48 |
| 2 hour | 3.41 ± 1.51 | 2.93 ± 2.02 |
| 4 hour | 2.91 ± 1.31 | 2.73 ± 2.28 |
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
| number of pills | Microcurrent TENS Device | Sham Device |
|---|---|---|
| Tylenol | 24.3 ± 30.83 | 16.4 ± 14.87 |
| Oxy | 2.5 ± 2.84 | 1.5 ± 2.29 |
Collected over 21 days. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Microcurrent TENS Device | 0/27 (0%) | 0/27 (0%) | 0/27 (0%) |
| Sham Device | 0/33 (0%) | 0/33 (0%) | 0/33 (0%) |
| Age, Continuous(years) | Microcurrent TENS Device | Sham Device | Total |
|---|---|---|---|
| Mean | 41.38 ± 14.63 | 39.55 ± 14.31 | 40.35 ± 14.35 |
| Sex: Female, Male(Participants) | Microcurrent TENS Device | Sham Device | Total |
|---|---|---|---|
| Female | 10 | 10 | 20 |
| Male | 17 | 23 | 40 |
| Race/Ethnicity, Customized(Participants) | Microcurrent TENS Device | Sham Device | Total |
|---|---|---|---|
| White (Caucasian) | 19 | 17 | 36 |
| Black or African American | 4 | 6 | 10 |
| Hispanic or Latino | 2 | 5 | 7 |
| Asian | 0 | 3 | 3 |
| Other | 0 | 1 | 1 |
| Prior Sinus Surgery(Participants) | Microcurrent TENS Device | Sham Device | Total |
|---|---|---|---|
| Count of participants | 25 | 5 | 30 |
| Pre-Operative Diagnosis(Participants) | Microcurrent TENS Device | Sham Device | Total |
|---|---|---|---|
| Chronic Rhinosinusitis without Polyposis | 16 | 19 | 35 |
| Chronic Rhinosinusitis with Polyposis | 8 | 6 | 14 |
| Other | 3 | 8 | 11 |
| Septoplasty(Participants) | Microcurrent TENS Device | Sham Device | Total |
|---|---|---|---|
| Count of participants | 18 | 22 | 40 |
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Plan to share: 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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Icahn School of Medicine at Mount Sinai