N/A N=149 Randomized Double-blind Treatment

Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

Endometrial Diseases · Pain, Postoperative

Bottom Line

View on ClinicalTrials.gov: NCT05472740 ↗

Enrolled (actual)

149

Serious AEs

0.7%

Results posted

Aug 2025

Primary outcome: Primary: Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS) — 50; 60 mm — p=0.039

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: TENS 7000 (Device)
Age: Adult, Older Adult · 18+ yrs
Sex: Female
Sponsor: Duke University
Primary completion: Dec 2023

Outcome Measures

Outcome	Result	p-value
PRIMARY Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS)	50; 60	0.039 sig
SECONDARY Measure of the Intervention Acceptability Based on Survey Response	0; 0	—
SECONDARY Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS)	17.5; 30	—
SECONDARY Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals	20; 10; 50; 55; 10; 20	—
SECONDARY Provider Satisfaction With the Procedure	—	—

Summary

The purpose of this study is to see whether transcutaneous electrical nerve stimulation (or TENS) reduces pain during an endometrial biopsy. A TENS unit is an over-the-counter, FDA approved device that sends low-level electrical impulses through the skin to reduce the amount of discomfort experienced during procedures. A TENS unit is very low-risk and used in a lot of ways, including for chronic pain, after surgery, and during labor. Since there is no standard way of managing discomfort during an endometrial biopsy, the investigators think that TENS might be helpful. Participating in the study may require some additional time in clinic to answer research-related questions. Subjects will be asked to answer demographic questions (which will be combined anonymously) before and after the procedure, as well as rate subject's pain at different time points during the procedure. The biggest benefit in participating is that subject's discomfort might be lower during and after the procedure. Subjects may not benefit from participating in this study. There is a small risk of a skin reaction from wearing the TENS pads.

Eligibility Criteria

Inclusion Criteria

at least 18 years old
undergoing an outpatient endometrial biopsy
Duke gynecological oncology clinics and general gynecology clinic

Exclusion Criteria

age younger than 18 years
unable to follow study instructions and/or independently adjust TENS settings
cutaneous damage at the TENS application site
pacemaker or automatic implanted cardiac defibrillator
inability to understand or declines to sign the informed consent form
previous personal experience using a TENS unit
concurrent procedure (ex. IUD placement at time of biopsy)
pregnant women (will be excluded as part of standard of care for endometrial evaluation)

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05472740). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.