Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

NCT05472740 | Completed Results DMC FDA Device

• 1 other identifier: Pro00111100
• Study Type: interventional
• Target: 149
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

endometrial biopsy; transcutaneous electrical nerve stimulation

Outcome Measures

Primary Outcomes (1)

• Pain After Endometrial Biopsy, as Measured by Visual Analogue Scale (VAS)

  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

  Immediately after endometrial biopsy

Secondary Outcomes (4)

• Measure of the Intervention Acceptability Based on Survey Response

  End of procedure

• Tolerability of Procedure, as Measured by Visual Analogue Scale (VAS)

  End of procedure

• Pain, as Measured by Visual Analogue Scale (VAS) Across Different Time Intervals

  Speculum placement, tenaculum placement, 5 minutes after biopsy, and 15 minutes after biopsy

• Provider Satisfaction With the Procedure

  End of procedure

Study Arms (2)

Active TENS

EXPERIMENTAL

Participants will be connected to a TENS 7000 that is turned on and working

Device: TENS 7000

Placebo TENS

PLACEBO COMPARATOR

Participants will be connected to a TENS 7000 however it will not be connected / will not be working

Device: TENS 7000

Interventions

TENS 7000 DEVICE

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

Active TENS; Placebo TENS

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27705, United States

Location

Related Publications (4)

• Lerma K, Goldthwaite LM, Blumenthal PD, Shaw KA. Transcutaneous Electrical Nerve Stimulation for Pain Management of Aspiration Abortion up to 83 Days of Gestation: A Randomized Controlled Trial. Obstet Gynecol. 2021 Sep 1;138(3):417-425. doi: 10.1097/AOG.0000000000004502.

  PMID: 34352845 BACKGROUND

• Yilmazer M, Kose S, Arioz DT, Koken G, Ozbulut O. Efficacy of transcutaneous electrical nerve stimulation for pain relief in women undergoing office endometrial biopsy. Arch Gynecol Obstet. 2012 Apr;285(4):1059-64. doi: 10.1007/s00404-011-2111-7. Epub 2011 Oct 19.

  PMID: 22009510 BACKGROUND

• Lison JF, Amer-Cuenca JJ, Piquer-Marti S, Benavent-Caballer V, Bivia-Roig G, Marin-Buck A. Transcutaneous Nerve Stimulation for Pain Relief During Office Hysteroscopy: A Randomized Controlled Trial. Obstet Gynecol. 2017 Feb;129(2):363-370. doi: 10.1097/AOG.0000000000001842.

  PMID: 28079781 BACKGROUND

• Wu J, Lim S, Scott A, Hayes T, Unnithan S, Erkanli A, Havrilesky LJ, Swartz JJ. Transcutaneous Electric Nerve Stimulation for Analgesia During Outpatient Endometrial Biopsy: A Randomized Controlled Trial. Obstet Gynecol. 2025 Jan 1;145(1):e14-e23. doi: 10.1097/AOG.0000000000005727. Epub 2024 Nov 21.

  PMID: 39575620 DERIVED

MeSH Terms

Conditions

Uterine Diseases; Pain, Postoperative

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Results Point of Contact

• Title: Amelia Scott, Research Program Leader
• Organization: Duke University

amelia.lorenzo@duke.edu

(919) 613-4584

Study Officials

• Laura Havrilesky, MD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: The participant and the provider completing the endometrial biopsy will be blinded to what group (intervention or placebo) that the subject is in. The clinical research coordinator assisting with the study and placement of the TENS will not be blinded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 22, 2022
• First Posted: July 25, 2022
• Study Start: December 13, 2022
• Primary Completion: December 26, 2023
• Study Completion: December 26, 2023
• Last Updated: August 22, 2025
• Results First Posted: August 22, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)