NCT05348005Completed
Use of TENS Unit in the Management of Endometriosis Pain
Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 40 (actual)
- First submitted
- 8 Dec 2021
- Start date
- 28 Jul 2022
- Primary completion date
- 16 Jul 2025
- Lead sponsor
- Milton S. Hershey Medical Center
- Diseases
- Endometriosis
- NCT number
- NCT05348005
What you commit to
- Study type: Interventional
- Participants enrolled: 40
- From 28 Jul 2022 to the primary completion date, 16 Jul 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Post-operative \<12 weeks from abdominal or pelvic surgery
- Planned surgery or hormonal medication changes for duration of study if applicable
Other illness
- TENS device exclusion:
- Implantable devices (pacemaker, Interstim, etc.)
- Cardiac arrhythmia
- Open skin sores over areas of placement
Other
- Pregnancy
- Nursing or trying to conceive at this time
- Non-English speaking or inability to read and understand English
- Prisoners
Who the study is looking for
- Females ages 18-45 years at time of enrollment
- A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis
- Average monthly endometriosis pain flare
- Naïve TENS user
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Penn State Health Milton S. Hershey Medical Center Coordinator of this site? Confirm its status | Hershey | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.