Use of TENS Unit in the Management of Endometriosis Pain

Description

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.

Conditions

Endometriosis, Pelvic Pain

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Study Overview

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Study Details

Study overview

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.

A Cross-Over Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain

Use of TENS Unit in the Management of Endometriosis Pain

Condition
Endometriosis
Intervention / Treatment

-

Contacts and Locations

Hershey

Penn State Health Milton S. Hershey Medical Center, Hershey, Pennsylvania, United States, 17033

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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

Ages Eligible for Study

18 Years to 45 Years

Sexes Eligible for Study

FEMALE

Accepts Healthy Volunteers

No

Collaborators and Investigators

Milton S. Hershey Medical Center,

Kristin W Riley, MD, PRINCIPAL_INVESTIGATOR, Penn State Health Hershey Medical Center

Study Record Dates

2026-05-01