Using TENS units to manage endometriosis pain

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study evaluates the effectiveness of Transcutaneous Electrical Nerve Stimulator (TENS) units in reducing pain associated with endometriosis flare-ups. Participants will first undergo a 3-month baseline period without TENS unit use, during which they will record their pain levels, medication use, and bleeding patterns. After this period, they will use the TENS unit for another 3 months while continuing to document their experiences in an online diary. The study aims to determine if TENS units can provide significant pain relief for individuals suffering from endometriosis.

Why it matters

Who can join: the full rules

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

Where it's running

• Penn State Health Milton S. Hershey Medical Center
  Hershey, Pennsylvania, United States Recruiting

Study contacts

• Principal investigator: Kristin W Riley, MD — Penn State Health Hershey Medical Center
• Study coordinator: Linda Li, MD
• Email: lindali@pennstatehealth.psu.edu
• Phone: 7175310003

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.