Trial Outcomes & Findings for Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy (NCT NCT05472740)
NCT ID: NCT05472740
Last Updated: 2025-08-22
Results Overview
Scores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
149 participants
Primary outcome timeframe
Immediately after endometrial biopsy
Results posted on
2025-08-22
Participant Flow
Participant milestones
| Measure |
Active TENS
Participants will be connected to a TENS 7000 that is turned on and working.
TENS 7000: TENS device to be used in both the active and placebo groups
|
Placebo TENS
Participants will be connected to a TENS 7000 however it will not be connected / will not be working.
TENS 7000: TENS device to be used in both the active and placebo groups
|
|---|---|---|
|
Overall Study
STARTED
|
75
|
74
|
|
Overall Study
COMPLETED
|
68
|
67
|
|
Overall Study
NOT COMPLETED
|
7
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy
Baseline characteristics by cohort
| Measure |
Active TENS
n=68 Participants
Participants will be connected to a TENS 7000 that is turned on and working
TENS 7000: TENS device to be used in both the active and placebo groups
|
Placebo TENS
n=67 Participants
Participants will be connected to a TENS 7000 however it will not be connected / will not be working
TENS 7000: TENS device to be used in both the active and placebo groups
|
Total
n=135 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
57 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
114 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
11 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
21 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
68 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
10 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
58 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
109 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
5 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
|
34 Participants
n=5 Participants
|
23 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
26 Participants
n=5 Participants
|
27 Participants
n=7 Participants
|
53 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
|
6 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
68 Participants
n=5 Participants
|
67 Participants
n=7 Participants
|
135 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Immediately after endometrial biopsyScores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain
Outcome measures
| Measure |
Active TENS
n=68 Participants
Participants will be connected to a TENS 7000 that is turned on and working
TENS 7000: TENS device to be used in both the active and placebo groups
|
Placebo TENS
n=67 Participants
Participants will be connected to a TENS 7000 however it will not be connected / will not be working
TENS 7000: TENS device to be used in both the active and placebo groups
|
|---|---|---|
|
Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS)
|
50 mm
Interval 20.0 to 80.0
|
60 mm
Interval 40.0 to 100.0
|
SECONDARY outcome
Timeframe: End of procedureA 0 to 100 mm scale similar to VAS (visual analog scale) to assess acceptability of TENS (Transcutaneous Electrical Nerve Stimulation) intervention. 0 - completely acceptable to 100 - not at all acceptable
Outcome measures
| Measure |
Active TENS
n=68 Participants
Participants will be connected to a TENS 7000 that is turned on and working
TENS 7000: TENS device to be used in both the active and placebo groups
|
Placebo TENS
n=67 Participants
Participants will be connected to a TENS 7000 however it will not be connected / will not be working
TENS 7000: TENS device to be used in both the active and placebo groups
|
|---|---|---|
|
Measure of the Intervention Acceptability Based on Survey Response
|
0 mm
Interval 0.0 to 22.5
|
0 mm
Interval 0.0 to 20.0
|
SECONDARY outcome
Timeframe: End of procedureA 0 to 100 mm scale similar to VAS to assess tolerability of TENS (Transcutaneous Electrical Nerve Stimulation) intervention.
Outcome measures
| Measure |
Active TENS
n=68 Participants
Participants will be connected to a TENS 7000 that is turned on and working
TENS 7000: TENS device to be used in both the active and placebo groups
|
Placebo TENS
n=67 Participants
Participants will be connected to a TENS 7000 however it will not be connected / will not be working
TENS 7000: TENS device to be used in both the active and placebo groups
|
|---|---|---|
|
Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS)
|
17.5 mm
Interval 0.0 to 60.0
|
30 mm
Interval 0.0 to 70.0
|
SECONDARY outcome
Timeframe: Speculum placement, tenaculum placement, 5 minutes after biopsy, and 15 minutes after biopsyScores are measured on a 100 mm VAS. The VAS ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain
Outcome measures
| Measure |
Active TENS
n=68 Participants
Participants will be connected to a TENS 7000 that is turned on and working
TENS 7000: TENS device to be used in both the active and placebo groups
|
Placebo TENS
n=67 Participants
Participants will be connected to a TENS 7000 however it will not be connected / will not be working
TENS 7000: TENS device to be used in both the active and placebo groups
|
|---|---|---|
|
Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals
Speculum Placement
|
20 mm
Interval 0.0 to 50.0
|
10 mm
Interval 0.0 to 40.0
|
|
Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals
Tenaculum Placement
|
50 mm
Interval 20.0 to 80.0
|
55 mm
Interval 30.0 to 80.0
|
|
Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals
5 min post biopsy
|
10 mm
Interval 0.0 to 40.0
|
20 mm
Interval 0.0 to 40.0
|
|
Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals
15 min post biopsy
|
7.5 mm
Interval 0.0 to 30.0
|
10 mm
Interval 0.0 to 30.0
|
SECONDARY outcome
Timeframe: End of procedurePopulation: Data not collected due to unavailability of providers post-procedure.
A 0 to 100 mm scale similar to VAS (visual analog scale) to assess provider satisfaction
Outcome measures
Outcome data not reported
Adverse Events
Active TENS
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo TENS
Serious events: 1 serious events
Other events: 1 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active TENS
n=75 participants at risk
Participants will be connected to a TENS 7000 that is turned on and working
TENS 7000: TENS device to be used in both the active and placebo groups
|
Placebo TENS
n=74 participants at risk
Participants will be connected to a TENS 7000 however it will not be connected / will not be working
TENS 7000: TENS device to be used in both the active and placebo groups
|
|---|---|---|
|
Gastrointestinal disorders
Esophageal dysphagia
|
0.00%
0/75 • Adverse event data were collected a week after the biopsy.
The study team looked for cases of post-procedural syncope, heavy bleeding, or reaction to TENS unit for a week following the biopsy. Any participant who experienced these was offered study withdrawal. Any need for hospitalization or death that was probably study related was immediately reported to the IRB.
|
1.4%
1/74 • Number of events 1 • Adverse event data were collected a week after the biopsy.
The study team looked for cases of post-procedural syncope, heavy bleeding, or reaction to TENS unit for a week following the biopsy. Any participant who experienced these was offered study withdrawal. Any need for hospitalization or death that was probably study related was immediately reported to the IRB.
|
Other adverse events
| Measure |
Active TENS
n=75 participants at risk
Participants will be connected to a TENS 7000 that is turned on and working
TENS 7000: TENS device to be used in both the active and placebo groups
|
Placebo TENS
n=74 participants at risk
Participants will be connected to a TENS 7000 however it will not be connected / will not be working
TENS 7000: TENS device to be used in both the active and placebo groups
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Possible electrode burn
|
0.00%
0/75 • Adverse event data were collected a week after the biopsy.
The study team looked for cases of post-procedural syncope, heavy bleeding, or reaction to TENS unit for a week following the biopsy. Any participant who experienced these was offered study withdrawal. Any need for hospitalization or death that was probably study related was immediately reported to the IRB.
|
1.4%
1/74 • Number of events 1 • Adverse event data were collected a week after the biopsy.
The study team looked for cases of post-procedural syncope, heavy bleeding, or reaction to TENS unit for a week following the biopsy. Any participant who experienced these was offered study withdrawal. Any need for hospitalization or death that was probably study related was immediately reported to the IRB.
|
Additional Information
Amelia Scott, Research Program Leader
Duke University
Phone: (919) 613-4584
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place