Trial Outcomes & Findings for Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During Cervical Dilator Placement Prior to Dilation and Evacuation (NCT NCT03868787)

Last Updated: 2023-07-25

Results Overview

Self-reported pain on 100mm visual analog scale (VAS) immediately following dilator placement. Range is from 0mm to 100mm, with 0mm being the least amount of pain (minimum score) and 100mm being the greatest (maximum score). Higher values are considered a worse outcome.

Recruitment status

COMPLETED

Study phase

Target enrollment

74 participants

Primary outcome timeframe

within 5 mins after dilator placement procedure

Results posted on

2023-07-25

Participant Flow

Participant milestones

Participant milestones
Measure	Active TENS The active TENS unit consists of the active unit and electrode pads connected to the unit via direct wires. The program that will be used is a high frequency (80Hz) program that runs for an hour in duration. It will be initiated 5 minutes prior to speculum placement. Participants will be instructed to increase the amplitude of the current as needed to provide analgesia but avoiding discomfort from the TENS stimulation TENS: TENS units are small, inexpensive, portable, battery-powered devices which deliver mild, alternating electrical currents via electrodes positioned on the skin near the anticipated dermatomal distribution of pain.	Sham TENS The sham TENS will be the same unit without the true TENS electrical connections. The sham group will be given the active unit and have electrode pads placed but without wire connections. These participants will be told the device is a wireless device. They will also be told they may or may not feel sensation from the TENS. This will allow the device to be powered on and run in the same manner as the active group, but will not allow for electrical transmission between the unit and electrodes Sham TENS: Non-active TENS unit
Overall Study STARTED	37	37
Overall Study COMPLETED	35	36
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Active TENS The active TENS unit consists of the active unit and electrode pads connected to the unit via direct wires. The program that will be used is a high frequency (80Hz) program that runs for an hour in duration. It will be initiated 5 minutes prior to speculum placement. Participants will be instructed to increase the amplitude of the current as needed to provide analgesia but avoiding discomfort from the TENS stimulation TENS: TENS units are small, inexpensive, portable, battery-powered devices which deliver mild, alternating electrical currents via electrodes positioned on the skin near the anticipated dermatomal distribution of pain.	Sham TENS The sham TENS will be the same unit without the true TENS electrical connections. The sham group will be given the active unit and have electrode pads placed but without wire connections. These participants will be told the device is a wireless device. They will also be told they may or may not feel sensation from the TENS. This will allow the device to be powered on and run in the same manner as the active group, but will not allow for electrical transmission between the unit and electrodes Sham TENS: Non-active TENS unit
Overall Study Withdrawal by Subject	2	1

Baseline Characteristics

Transcutaneous Electrical Nerve Stimulation (TENS) for Pain Control During Cervical Dilator Placement Prior to Dilation and Evacuation

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active TENS n=37 Participants The active TENS unit consists of the active unit and electrode pads connected to the unit via direct wires. The program that will be used is a high frequency (80Hz) program that runs for an hour in duration. It will be initiated 5 minutes prior to speculum placement. Participants will be instructed to increase the amplitude of the current as needed to provide analgesia but avoiding discomfort from the TENS stimulation TENS: TENS units are small, inexpensive, portable, battery-powered devices which deliver mild, alternating electrical currents via electrodes positioned on the skin near the anticipated dermatomal distribution of pain.	Sham TENS n=37 Participants The sham TENS will be the same unit without the true TENS electrical connections. The sham group will be given the active unit and have electrode pads placed but without wire connections. These participants will be told the device is a wireless device. They will also be told they may or may not feel sensation from the TENS. This will allow the device to be powered on and run in the same manner as the active group, but will not allow for electrical transmission between the unit and electrodes Sham TENS: Non-active TENS unit	Total n=74 Participants Total of all reporting groups
Age, Continuous	32 years n=5 Participants	34 years n=7 Participants	33 years n=5 Participants
Sex: Female, Male Female	37 Participants n=5 Participants	37 Participants n=7 Participants	74 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants	5 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	8 Participants n=5 Participants	6 Participants n=7 Participants	14 Participants n=5 Participants
Race (NIH/OMB) White	26 Participants n=5 Participants	23 Participants n=7 Participants	49 Participants n=5 Participants
Race (NIH/OMB) More than one race	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Region of Enrollment United States	37 participants n=5 Participants	37 participants n=7 Participants	74 participants n=5 Participants
Parity	1 Living Children n=5 Participants	1 Living Children n=7 Participants	1 Living Children n=5 Participants
BMI	26.7 Kg/m^2 n=5 Participants	25.5 Kg/m^2 n=7 Participants	25.7 Kg/m^2 n=5 Participants

PRIMARY outcome

Timeframe: within 5 mins after dilator placement procedure

Outcome measures

Outcome measures
Measure	Active TENS n=35 Participants The active TENS unit consists of the active unit and electrode pads connected to the unit via direct wires. The program that will be used is a high frequency (80Hz) program that runs for an hour in duration. It will be initiated 5 minutes prior to speculum placement. Participants will be instructed to increase the amplitude of the current as needed to provide analgesia but avoiding discomfort from the TENS stimulation TENS: TENS units are small, inexpensive, portable, battery-powered devices which deliver mild, alternating electrical currents via electrodes positioned on the skin near the anticipated dermatomal distribution of pain.	Sham TENS n=36 Participants The sham TENS will be the same unit without the true TENS electrical connections. The sham group will be given the active unit and have electrode pads placed but without wire connections. These participants will be told the device is a wireless device. They will also be told they may or may not feel sensation from the TENS. This will allow the device to be powered on and run in the same manner as the active group, but will not allow for electrical transmission between the unit and electrodes Sham TENS: Non-active TENS unit
Pain Following Dilator Placement	64 units on a scale Interval 7.0 to 94.0	60.5 units on a scale Interval 6.0 to 100.0

SECONDARY outcome

Timeframe: 5 mins after dilator placement to 36 hours after dilator placement

Self-reported highest level of pain between dilator placement and D\&E on 100mm visual analog scale (VAS). Range is from 0mm to 100mm, with 0mm being the least amount of pain (minimum score) and 100mm being the greatest (maximum score). Higher values are considered a worse outcome.

Outcome measures

Outcome measures
Measure	Active TENS n=35 Participants The active TENS unit consists of the active unit and electrode pads connected to the unit via direct wires. The program that will be used is a high frequency (80Hz) program that runs for an hour in duration. It will be initiated 5 minutes prior to speculum placement. Participants will be instructed to increase the amplitude of the current as needed to provide analgesia but avoiding discomfort from the TENS stimulation TENS: TENS units are small, inexpensive, portable, battery-powered devices which deliver mild, alternating electrical currents via electrodes positioned on the skin near the anticipated dermatomal distribution of pain.	Sham TENS n=36 Participants The sham TENS will be the same unit without the true TENS electrical connections. The sham group will be given the active unit and have electrode pads placed but without wire connections. These participants will be told the device is a wireless device. They will also be told they may or may not feel sensation from the TENS. This will allow the device to be powered on and run in the same manner as the active group, but will not allow for electrical transmission between the unit and electrodes Sham TENS: Non-active TENS unit
Interval Pain	39 units on a scale Interval 0.0 to 89.0	55 units on a scale Interval 0.0 to 100.0

SECONDARY outcome

Timeframe: 24-36 hours after dilator placement, immediately prior to D&E

Patient satisfaction with device based on 4 questions with 5 point Likert scale. Minimum value is 1, maximum is 5. Higher score is a better outcome.

Outcome measures

Outcome measures
Measure	Active TENS n=35 Participants The active TENS unit consists of the active unit and electrode pads connected to the unit via direct wires. The program that will be used is a high frequency (80Hz) program that runs for an hour in duration. It will be initiated 5 minutes prior to speculum placement. Participants will be instructed to increase the amplitude of the current as needed to provide analgesia but avoiding discomfort from the TENS stimulation TENS: TENS units are small, inexpensive, portable, battery-powered devices which deliver mild, alternating electrical currents via electrodes positioned on the skin near the anticipated dermatomal distribution of pain.	Sham TENS n=36 Participants The sham TENS will be the same unit without the true TENS electrical connections. The sham group will be given the active unit and have electrode pads placed but without wire connections. These participants will be told the device is a wireless device. They will also be told they may or may not feel sensation from the TENS. This will allow the device to be powered on and run in the same manner as the active group, but will not allow for electrical transmission between the unit and electrodes Sham TENS: Non-active TENS unit
Patient Satisfaction Would you use again	3 score on a scale Interval 1.0 to 5.0	2 score on a scale Interval 1.0 to 5.0
Patient Satisfaction Pain control	4 score on a scale Interval 2.0 to 5.0	3 score on a scale Interval 1.0 to 5.0
Patient Satisfaction Comfort	5 score on a scale Interval 1.0 to 5.0	4 score on a scale Interval 1.0 to 5.0
Patient Satisfaction Ease of use	2 score on a scale Interval 1.0 to 5.0	4 score on a scale Interval 1.0 to 5.0

Adverse Events

Active TENS

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Sham TENS

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

Ashley Turner, MD Assistant Professor of Obstetrics and Gynecology

Northwestern University Feinberg School of Medicine

Phone: 2316200549

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place