Trial Outcomes & Findings for Efficacy of Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Reduction During Intrauterine Device (IUD) Insertion in Outpatient Gynecology (NCT NCT06335823)
NCT ID: NCT06335823
Last Updated: 2026-03-02
Results Overview
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
60 participants
Primary outcome timeframe
IUD placement/introducer removal up to 5 minute
Results posted on
2026-03-02
Participant Flow
Participant milestones
| Measure |
Active TENS Unit
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
|
Non-active TENS Unit
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.
Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.
|
|---|---|---|
|
Overall Study
STARTED
|
29
|
31
|
|
Overall Study
COMPLETED
|
26
|
27
|
|
Overall Study
NOT COMPLETED
|
3
|
4
|
Reasons for withdrawal
| Measure |
Active TENS Unit
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
|
Non-active TENS Unit
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.
Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.
|
|---|---|---|
|
Overall Study
Unable to place IUD
|
3
|
4
|
Baseline Characteristics
1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
Baseline characteristics by cohort
| Measure |
Active TENS Unit
n=29 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
|
Non-active TENS Unit
n=31 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.
Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
28.9 years
STANDARD_DEVIATION 8.2 • n=29 Participants
|
30.8 years
STANDARD_DEVIATION 8.8 • n=31 Participants
|
30.4 years
STANDARD_DEVIATION 8.9 • n=60 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=29 Participants
|
31 Participants
n=31 Participants
|
60 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=29 Participants
|
3 Participants
n=31 Participants
|
4 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=29 Participants
|
28 Participants
n=31 Participants
|
55 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
1 Participants
n=60 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=29 Participants
|
2 Participants
n=31 Participants
|
2 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
0 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=29 Participants
|
6 Participants
n=31 Participants
|
6 Participants
n=60 Participants
|
|
Race (NIH/OMB)
White
|
24 Participants
n=29 Participants
|
22 Participants
n=31 Participants
|
46 Participants
n=60 Participants
|
|
Race (NIH/OMB)
More than one race
|
3 Participants
n=29 Participants
|
1 Participants
n=31 Participants
|
4 Participants
n=60 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=29 Participants
|
0 Participants
n=31 Participants
|
2 Participants
n=60 Participants
|
|
History of Prior Pregnancy
0 Deliveries
|
24 Participants
n=29 Participants
|
17 Participants
n=31 Participants
|
41 Participants
n=60 Participants
|
|
History of Prior Pregnancy
1 or more deliveries
|
5 Participants
n=29 Participants
|
14 Participants
n=31 Participants
|
19 Participants
n=60 Participants
|
|
Education Level
High school or equivalent
|
8 participants
n=29 Participants
|
12 participants
n=31 Participants
|
20 participants
n=60 Participants
|
|
Education Level
Bachelors degree or higher
|
21 participants
n=29 Participants
|
19 participants
n=31 Participants
|
40 participants
n=60 Participants
|
|
Dysmenorrhea
No pain
|
7 Participants
n=29 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
8 Participants
n=30 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
15 Participants
n=59 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
|
Dysmenorrhea
Mild pain
|
6 Participants
n=29 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
6 Participants
n=30 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
12 Participants
n=59 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
|
Dysmenorrhea
Moderate pain
|
7 Participants
n=29 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
10 Participants
n=30 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
17 Participants
n=59 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
|
Dysmenorrhea
Severe pain
|
7 Participants
n=29 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
3 Participants
n=30 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
10 Participants
n=59 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
|
Dysmenorrhea
Worst pain imaginable
|
2 Participants
n=29 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
3 Participants
n=30 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
5 Participants
n=59 Participants • 1 participant in the Non-active TENS unit did not fill out this question on the survey, no data for that participant.
|
|
Chronic Pain Disease
Yes
|
8 Participants
n=29 Participants
|
9 Participants
n=31 Participants
|
17 Participants
n=60 Participants
|
|
Chronic Pain Disease
No
|
21 Participants
n=29 Participants
|
22 Participants
n=31 Participants
|
43 Participants
n=60 Participants
|
|
BMI
|
29.4 kg/m^2
STANDARD_DEVIATION 8.4 • n=29 Participants
|
30.3 kg/m^2
STANDARD_DEVIATION 10.4 • n=31 Participants
|
29.8 kg/m^2
STANDARD_DEVIATION 9.4 • n=60 Participants
|
|
History of Vaginal Delivery
Yes
|
3 Participants
n=29 Participants
|
13 Participants
n=31 Participants
|
16 Participants
n=60 Participants
|
|
History of Vaginal Delivery
No
|
26 Participants
n=29 Participants
|
18 Participants
n=31 Participants
|
44 Participants
n=60 Participants
|
|
Marijuana Use
No use
|
17 Participants
n=29 Participants
|
20 Participants
n=31 Participants
|
37 Participants
n=60 Participants
|
|
Marijuana Use
Daily
|
2 Participants
n=29 Participants
|
5 Participants
n=31 Participants
|
7 Participants
n=60 Participants
|
|
Marijuana Use
Weekly
|
2 Participants
n=29 Participants
|
1 Participants
n=31 Participants
|
3 Participants
n=60 Participants
|
|
Marijuana Use
Monthly
|
2 Participants
n=29 Participants
|
2 Participants
n=31 Participants
|
4 Participants
n=60 Participants
|
|
Marijuana Use
Rarely
|
5 Participants
n=29 Participants
|
1 Participants
n=31 Participants
|
6 Participants
n=60 Participants
|
|
Marijuana Use
N/A - Age<21
|
1 Participants
n=29 Participants
|
2 Participants
n=31 Participants
|
3 Participants
n=60 Participants
|
PRIMARY outcome
Timeframe: IUD placement/introducer removal up to 5 minuteThe VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
Outcome measures
| Measure |
Active TENS Unit
n=26 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
|
Non-active TENS Unit
n=27 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.
Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.
|
|---|---|---|
|
Pain During IUD Insertion as Measured by the VAS Score
|
6.46 score on a scale
Standard Deviation 2.34
|
5.63 score on a scale
Standard Deviation 2.6
|
SECONDARY outcome
Timeframe: speculum placement up to 1 minutePopulation: VAS data was broken down by cervical block or no cervical block.
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
Outcome measures
| Measure |
Active TENS Unit
n=26 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
|
Non-active TENS Unit
n=27 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.
Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.
|
|---|---|---|
|
Pain During IUD Insertion as Measured by the VAS Score
No Cervical Block
|
2.20 score on a scale
Standard Deviation 2.28
|
1.20 score on a scale
Standard Deviation 2.67
|
|
Pain During IUD Insertion as Measured by the VAS Score
Cervical Block
|
2.67 score on a scale
Standard Deviation 2.54
|
1.64 score on a scale
Standard Deviation 1.81
|
SECONDARY outcome
Timeframe: tenaculum placement up to 1 minutePopulation: VAS data was broken down by cervical block or no cervical block.
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
Outcome measures
| Measure |
Active TENS Unit
n=26 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
|
Non-active TENS Unit
n=27 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.
Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.
|
|---|---|---|
|
Pain During IUD Insertion as Measured by the VAS Score
No Cervical Block
|
3.60 score on a scale
Standard Deviation 1.67
|
1.80 score on a scale
Standard Deviation 2.49
|
|
Pain During IUD Insertion as Measured by the VAS Score
Cervical Block
|
2.52 score on a scale
Standard Deviation 1.75
|
2.41 score on a scale
Standard Deviation 2.08
|
SECONDARY outcome
Timeframe: sound insertion up to 5 minutePopulation: VAS data was broken down by cervical block or no cervical block
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
Outcome measures
| Measure |
Active TENS Unit
n=26 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
|
Non-active TENS Unit
n=27 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.
Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.
|
|---|---|---|
|
Pain During IUD Insertion as Measured by the VAS Score
Cervical Block
|
6.00 score on a scale
Standard Deviation 2.02
|
4.73 score on a scale
Standard Deviation 2.25
|
|
Pain During IUD Insertion as Measured by the VAS Score
No Cervical Block
|
5.80 score on a scale
Standard Deviation 1.64
|
3.20 score on a scale
Standard Deviation 1.92
|
SECONDARY outcome
Timeframe: 5 minute post IUD insertionPopulation: VAS data broken down by cervical block or no cervical block
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
Outcome measures
| Measure |
Active TENS Unit
n=26 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
|
Non-active TENS Unit
n=27 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.
Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.
|
|---|---|---|
|
Pain Post IUD Insertion as Measured by the VAS Score
Cervical Block
|
2.81 score on a scale
Standard Deviation 1.75
|
2.82 score on a scale
Standard Deviation 2.46
|
|
Pain Post IUD Insertion as Measured by the VAS Score
No cervical Block
|
2.00 score on a scale
Standard Deviation 1.41
|
6.40 score on a scale
Standard Deviation 1.34
|
OTHER_PRE_SPECIFIED outcome
Timeframe: baselinePopulation: VAS data broken down by Cervical block or no cervical block
The VAS score is a score of 0-10 with 0 being no pain and 10 being the worse pain imaginable
Outcome measures
| Measure |
Active TENS Unit
n=26 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients in this arm will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit turned on and half will have the TENS unit turned on to a 80 hz preset frequency with 100 mA as the pulse width.
|
Non-active TENS Unit
n=27 Participants
All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will not have the TENS unit turned on.
Placebo Transcutaneous electrical nerve stimulation (TENS): All patients will have the TENS unit applied: 2 pads from channel 1 will be at T10-L1 and the second set of pads will be from S2-S4; 5 minutes prior to the start of the procedure. Patients will have the TENS unit will not be turned on.
|
|---|---|---|
|
Pain Prior to IUD Insertion as Measured by the VAS Score
Cervical Block
|
0.43 score on a scale
Standard Deviation 1.25
|
0.00 score on a scale
Standard Deviation 0.00
|
|
Pain Prior to IUD Insertion as Measured by the VAS Score
No Cervical Block
|
0.60 score on a scale
Standard Deviation 1.34
|
0.00 score on a scale
Standard Deviation 0.00
|
Adverse Events
Active TENS Unit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Non-active TENS Unit
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Jean Marino
University Hospitals Cleveland Medical Center
Phone: 216-844-8879
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place