NCT05472740

Transcutaneous Electrical Nerve Stimulation During Outpatient Endometrial Biopsy

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 149 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

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

Type	Name	Description
DEVICE	TENS 7000	TENS device to be used in both the active and placebo groups

Timeline

• Start date: 2022-12-13
• Primary completion: 2023-12-26
• Completion: 2023-12-26
• First posted: 2022-07-25
• Last updated: 2025-08-22
• Results posted: 2025-08-22

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study