Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

Transcutaneous Electrical Nerve Stimulation for Analgesia During Outpatient Endometrial Biopsy: a Randomized Controlled Trial

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative; Endometrial Diseases
• Intervention / Treatment: Device: TENS 7000

• Study Type: Interventional
• Enrollment (Actual): 149
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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
• pregnant women (will be excluded as part of standard of care for endometrial evaluation)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active TENS; Participants will be connected to a TENS 7000 that is turned on and working	Device: TENS 7000; TENS device to be used in both the active and placebo groups
Placebo Comparator: Placebo TENS; Participants will be connected to a TENS 7000 however it will not be connected / will not be working	Device: TENS 7000; TENS device to be used in both the active and placebo groups

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants who find the intervention acceptable based on survey response	A 0 to 100 mm scale similar to VAS to assess acceptability of TENS intervention	End of procedure
Number of participants who find the intervention tolerable based on survey response	A 0 to 100 mm scale similar to VAS to assess tolerability of TENS intervention	End of procedure
Change in Pain, as measured by Visual Analogue Scale (VAS) across different time intervals	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	Speculum placement, tenaculum placement, 5 minutes after biopsy, and 15 minutes after biopsy
Provider satisfaction with the procedure	A 0 to 100 mm scale similar to VAS to assess provider satisfaction	End of procedure

Collaborators and Investigators

• Sponsor: Duke University
• Investigators: Principal Investigator: Laura Havrilesky, MD, Duke University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): December 13, 2022
• Primary Completion (Actual): December 26, 2023
• Study Completion (Actual): December 26, 2023

Study Registration Dates

• First Submitted: July 22, 2022
• First Submitted That Met QC Criteria: July 22, 2022
• First Posted (Actual): July 25, 2022

Study Record Updates

• Last Update Posted (Estimated): February 9, 2024
• Last Update Submitted That Met QC Criteria: February 8, 2024
• Last Verified: February 1, 2024

More Information

Terms related to this study

• Keywords: transcutaneous electrical nerve stimulation; endometrial biopsy
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Pain, Postoperative; Uterine Diseases
• Other Study ID Numbers: Pro00111100

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes