Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05472740
• Other study ID #: Pro00111100
• Status: Completed
• Phase: N/A
• Start date: December 13, 2022
• Est. completion date: December 26, 2023

Study information

• Verified date: February 2024
• Source: Duke University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 149
• Est. completion date: December 26, 2023
• Est. primary completion date: December 26, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Endometrial Diseases
• Pain, Postoperative
• Uterine Diseases

Intervention

Device:
• TENS 7000
TENS device to be used in both the active and placebo groups

Locations

Country	Name	City	State
United States	Duke University Medical Center	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Duke University

Country where clinical trial is conducted

United States, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	Provider satisfaction with the procedure	A 0 to 100 mm scale similar to VAS to assess provider satisfaction	End of procedure