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COMPLETED
NCT05348005
NA

Use of TENS Unit in the Management of Endometriosis Pain

Sponsor: Milton S. Hershey Medical Center

View on ClinicalTrials.gov

Summary

The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. TENS units have a 510K and are intended for relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. Participants will complete surveys, record pain, medication use and bleeding in an online diary during endometriosis flare ups for 3 months without using the TENS unit. After the first 3 month period of time, a TENS unit will be given to participants to wear and again, record pain, medication use and bleeding in the online diary during endometriosis flare ups for and additional 3 months while using the TENS unit.

Official title: Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain

Key Details

Gender

FEMALE

Age Range

18 Years - 45 Years

Study Type

INTERVENTIONAL

Enrollment

40

Start Date

2022-07-28

Completion Date

2025-07-16

Last Updated

2026-08-04

Healthy Volunteers

No

Interventions

DEVICE

Ovira Transcutaneous Electrical Nerve Stimulation Unit

TENS units have a wide application from treatment of chronic back pain, chronic abdominal pain, cancer pain, perioperative pain, and labor pain.19-24 TENS units have been shown to be well-tolerated with minimal side effects and have been successful in reducing pain as well as pain medication use in patients with primary dysmenorrhea, which excludes pathology such as endometriosis. 11-18 Certain TENS units have also been FDA approved for the general indication of pelvic pain.

Locations (1)

Penn State Health Milton S. Hershey Medical Center

Hershey, Pennsylvania, United States