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Completed
NCT05348005
Use of TENS Unit in the Management of Endometriosis Pain
Conditions: Endometriosis, Pelvic Pain
Sex: Female
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 40
Sponsor: Milton S. Hershey Medical Center
Location: Penn State Health Milton S. Hershey Medical Center Hershey Pennsylvania
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.
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 \
Source: ClinicalTrials.gov (NCT05348005). StuddyBuddy aggregates publicly available trial information.
