Status:
COMPLETED
Use of TENS Unit in the Management of Endometriosis Pain
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Endometriosis
Pelvic Pain
Eligibility:
FEMALE
18-45 years
Phase:
NA
Brief 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 associate...
Detailed Description
The investigators propose to conduct a cross-over clinical study to evaluate the effectiveness of TENS units on the management of endometriosis flare-related pain. Subjects will participate in a 3-mon...
Eligibility Criteria
Inclusion
- 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
Exclusion
- TENS device exclusion:
- Implantable devices (pacemaker, Interstim, etc.)
- Cardiac arrhythmia
- Open skin sores over areas of placement
- Pregnancy
- Nursing or trying to conceive at this time
- Post-operative \<12 weeks from abdominal or pelvic surgery
- Planned surgery or hormonal medication changes for duration of study if applicable
- Non-English speaking or inability to read and understand English
- Prisoners
Key Trial Info
Start Date :
July 28 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 16 2025
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT05348005
Start Date
July 28 2022
End Date
July 16 2025
Last Update
October 20 2025
Active Locations (1)
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1
Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, United States, 17033