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Search / Trial NCT05348005

Use of TENS Unit in the Management of Endometriosis Pain

Launched by MILTON S. HERSHEY MEDICAL CENTER · Apr 22, 2022

Trial Information

Current as of July 08, 2025

Recruiting

Keywords

ClinConnect Summary

This clinical trial is looking at whether a device called a Transcutaneous Electrical Nerve Stimulator (TENS) can help reduce pain caused by endometriosis, a condition that affects many women and can cause severe pelvic pain. In this study, women between the ages of 18 and 45 who have been diagnosed with endometriosis and experience regular pain flare-ups can participate. Initially, participants will keep track of their pain levels, medication use, and any bleeding for three months without using the TENS unit. After this period, they will use the TENS unit for another three months while continuing to record their experiences.

Participants in this trial can expect to fill out online surveys and diaries to document their pain and other symptoms. It's important to note that not everyone can join the study; for example, women who are pregnant, nursing, or have certain medical conditions like heart problems or recent surgeries are excluded. This study aims to provide valuable information about whether using a TENS unit can improve the quality of life for women suffering from endometriosis pain.

Gender

FEMALE

Eligibility criteria

  • Inclusion Criteria:
  • 1. Females ages 18-45 years at time of enrollment
  • 2. A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis
  • 3. Average monthly endometriosis pain flare
  • 4. Naïve TENS user
  • Exclusion Criteria:
  • 1. TENS device exclusion:
  • 1. Implantable devices (pacemaker, Interstim, etc.)
  • 2. Cardiac arrhythmia
  • 3. Open skin sores over areas of placement
  • 2. Pregnancy
  • 3. Nursing or trying to conceive at this time
  • 4. Post-operative \<12 weeks from abdominal or pelvic surgery
  • 5. Planned surgery or hormonal medication changes for duration of study if applicable
  • 6. Non-English speaking or inability to read and understand English
  • 7. Prisoners

About Milton S. Hershey Medical Center

Milton S. Hershey Medical Center, a leading academic medical institution affiliated with Penn State University, is dedicated to advancing healthcare through innovative research and clinical trials. With a strong emphasis on patient-centered care, the center leverages its expertise in various medical fields to conduct rigorous clinical studies aimed at improving treatment outcomes and enhancing the understanding of complex health conditions. The facility is committed to ethical research practices and fostering collaboration among multidisciplinary teams, ensuring that participants receive the highest standard of care while contributing to the advancement of medical knowledge.

Locations

Hershey, Pennsylvania, United States

Patients applied

0 patients applied

Trial Officials

Kristin W Riley, MD

Principal Investigator

Penn State Health Hershey Medical Center

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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