An interventional study of Transcutaneous Electrical Nerve Stimulation (TENS) in Pain, sponsored by Icahn School of Medicine at Mount Sinai. Completed at 5 sites in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-07-06.
Sponsored by Icahn School of Medicine at Mount Sinai · Not applicable, Interventional, and Treatment
This study is a double-blind, randomized, placebo-controlled trial to evaluate the use of high frequency TENS for pain control during IUD insertion. Transcutaneous electrical nerve stimulation (TENS) is a relatively low-cost, low-risk, non-pharmacologic intervention for pain management. Previous studies have found that TENS reduces pain associated with other outpatient gynecological procedures. Participants will be randomized in a 1:1 ratio to either active treatment or placebo (placebo TENS) and record pain scores using a 100 mm visual analog scale (VAS) at the time of IUD insertion. The same device will be used for both active and placebo treatment.
The researchers will recruit eligible participants from patients who opt for IUD initiation during ambulatory care visits to the Mount Sinai Complex Family Planning service at Mount Sinai Hospital, Mount Sinai Beth Israel, Mount Sinai Morningside, and Mount Sinai West. Allocation to treatment will be based on a 1:1 blocked randomization scheme stratified by parity. A member of the research/clinical team other than the person performing IUD insertion will identify the treatment allocation assigned to the corresponding subject ID. The team member will set up the TENS unit accordingly by applying pads to the participant and initiating treatment with the correct settings. When setup is complete (\<5 minutes), the person performing the IUD insertion and other clinical staff assisting with the procedure will enter the exam room with no knowledge of TENS treatment assignment to insert the IUD.
REDCap, a HIPAA-compliant, secure web application used for building and managing online surveys and databases, will be used for data collection in this study. Participants will complete electronic surveys in REDCap during the study. The first survey is a baseline survey to collect demographics as well as medical, obstetric, and gynecologic history and other characteristics prior to the IUD insertion procedure.
IUD insertion will be performed by complex family planning faculty and fellows, as well as OB/GYN residents on their family planning rotation. A research staff member will be within reach of the study participant during the procedure to collect pain scores using a visual analog scale (VAS) presented on an iPad.
The second survey will have a visual analog scale for study participants to rate their pain between 0 and 100 at the following timepoints during IUD insertion:
The third survey will ask participants about reflections on their experience with IUD insertion and acceptability of the TENS device. Participation in the study is expected to only last one day, the day of IUD insertion.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's enrollment of 99 is above the median of 70 across 1,904 interventional studies indexed under Pain.
Browse Pain studies →Icahn School of Medicine at Mount Sinai is the lead sponsor of 764 studies on the registry; 181 are open to participants now.
Of its 121 completed or terminated interventional studies of FDA-regulated products, 82 (68%) have results posted.
Counted across the registry records on this site, refreshed daily.
In order to participate in the study, an individual must meet all the following criteria:
Exclusion Criteria:
For the Active TENS group, the device will be set to 80 Hz (hfTENS) and device intensity (0-8) will be titrated to patient comfort, as is the standard protocol for TENS use.
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
For the placebo TENS group, setup will be identical, but the device will not be turned on.
Device: Transcutaneous Electrical Nerve Stimulation (TENS)
TENS 7000 digital TENS unit, a low cost, over the counter, battery operated device with high consumer ratings. The handheld device works by transmitting an electronically generated topical stimulus to a specified area on the body to alter response to pain signals and promote endogenous endorphin release for pain reduction.
Pain Score on Pain Visual Analog Scale
Participant reported maximum pain score on Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.
Time frame: Day 1 (Day of IUD Insertion)
Maximum Pain Score on Pain Visual Analog Scale
Participant reported maximum pain score on Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.
Time frame: Day 1 (Day of IUD Insertion)
Post Procedure Survey Question - Acceptability of the Device
Acceptability of the TENS device. Questions answered as yes or no. This is not a scale and has no min or max score.
Time frame: Day 1 (Day of IUD Insertion)
| Milestone | Active TENS | Placebo TENS |
|---|---|---|
| Started | 49 | 50 |
| Completed | 48 | 50 |
| Not completed | 1 | 0 |
| Withdrew: Physician decision | 1 | 0 |
Participant reported maximum pain score on Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.
| score on a scale | Active TENS | Placebo TENS |
|---|---|---|
| Pain Score on Pain Visual Analog Scale | 50.8 ± 26.9 | 50.6 ± 29.2 |
Participant reported maximum pain score on Pain Visual Analog Scale - full scale from 0-100, higher score indicates higher level of pain.
| score on a scale | Active TENS | Placebo TENS |
|---|---|---|
| Maximum Pain Score on Pain Visual Analog Scale | 57.6 ± 26.2 | 63.2 ± 24.1 |
Acceptability of the TENS device. Questions answered as yes or no. This is not a scale and has no min or max score.
| Participants | Active TENS | Placebo TENS |
|---|---|---|
| Post Procedure Survey Question - Acceptability of the Device | 44 | 38 |
Collected over 1 Day. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Active TENS | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Placebo TENS | 0/49 (0%) | 0/49 (0%) | 0/49 (0%) |
| Age, Continuous(years) | Active TENS | Placebo TENS | Total |
|---|---|---|---|
| Median | 29.0 (25.0 to 34.0) | 28.0 (23.0 to 35.0) | 29.0 (25.0 to 35.0) |
| Sex: Female, Male(Participants) | Active TENS | Placebo TENS | Total |
|---|---|---|---|
| Female | 48 | 50 | 98 |
| Male | 0 | 0 | 0 |
| Ethnicity (NIH/OMB)(Participants) | Active TENS | Placebo TENS | Total |
|---|---|---|---|
| Hispanic or Latino | 22 | 18 | 40 |
| Not Hispanic or Latino | 24 | 28 | 52 |
| Unknown or Not Reported | 2 | 4 | 6 |
| Race (NIH/OMB)(Participants) | Active TENS | Placebo TENS | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 5 | 6 | 11 |
| Native Hawaiian or Other Pacific Islander | 1 | 0 | 1 |
| Black or African American | 11 | 18 | 29 |
| White | 17 | 19 | 36 |
| More than one race | 3 | 1 | 4 |
| Unknown or Not Reported | 11 | 6 | 17 |
| Education Level(Participants) | Active TENS | Placebo TENS | Total |
|---|---|---|---|
| Some High School | 2 | 1 | 3 |
| High School/GED Equivalent | 15 | 17 | 32 |
| Trade School | 1 | 4 | 5 |
| Bachelor's Degree | 18 | 20 | 38 |
| Master's Degree | 9 | 5 | 14 |
| Doctorate or Higher | 1 | 2 | 3 |
| Prefer not to say | 2 | 1 | 3 |
| Insurance(Participants) | Active TENS | Placebo TENS | Total |
|---|---|---|---|
| Commercial Insurance | 23 | 23 | 46 |
| Medicaid Managed Care | 22 | 25 | 47 |
| Medicare | 0 | 1 | 1 |
| Self-pay | 1 | 0 | 1 |
| Straight Medicaid | 2 | 1 | 3 |
| Body Mass Index (BMI)(Kg/m^2) | Active TENS | Placebo TENS | Total |
|---|---|---|---|
| Median | 24.5 (21.6 to 28.8) | 27.3 (23.6 to 30.5) | 26.4 (22.3 to 30.1) |
| Medical History(Participants) | Active TENS | Placebo TENS | Total |
|---|---|---|---|
| None | 26 | 30 | 56 |
| Anxiety | 20 | 10 | 30 |
| Depression | 13 | 8 | 21 |
| Not counted | 0 | 2 | 2 |
7 further baseline measures are reported on the registry.
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — Individual participant data meta-analysis for this study will not be done. De-identified individual participant data will be analyzed according to the statistical plan mentioned in the study protocol for manuscript preparation and journal publication. Individual participant data will be shared within the study team. Also, IPD will be shared with the IRB according to institutional guidelines.
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Icahn School of Medicine at Mount Sinai