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.

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.

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

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

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)

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.