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Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

NCT05472740 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 149

Last updated 2025-08-22

Study results available
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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.

Conditions

  • Endometrial Diseases
  • Pain, Postoperative

Interventions

DEVICE

TENS 7000

TENS device to be used in both the active and placebo groups

Sponsors & Collaborators

Principal Investigators

  • Laura Havrilesky, MD · Duke University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-12-13
Primary Completion
2023-12-26
Completion
2023-12-26
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05472740 on ClinicalTrials.gov