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A Pre-Post Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain

The purpose of this study is see if Transcutaneous Electrical Nerve Stimulator (TENS) units help decrease endometriosis flare pain. 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.

There will be one in person enrollment visit, involving being consented and completion of 2 surveys. The first 3 months, the "baseline period" will include filling out pain scores online on days of endometriosis flare without TENS unit use. The next 3 months, the "treatment period" will include filling out pain scores online on days of endometriosis flare with TENS unit. At end of study completion of 2 surveys.

Yes
 

Kristin Riley
Patricia Rawa - at prawa@pennstatehealth.psu.edu
Obstetrics and Gynecology (HERSHEY)
 

Female
18 year(s) or older
This study is NOT accepting healthy volunteers
NCT05348005
STUDY00019024
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Inclusion Criteria:
Women aged 18 to 45 years, inclusive,
Surgical diagnosis of endometriosis, visualized and/or pathology confirmed
Having monthly endometriosis pain flares on average
Has never used a TENS unit before for endometriosis pain flares
Must be greater than 12 weeks post-op for abdominal/pelvic surgery

Exclusion Criteria:
Has an implantable device (e.g. pacemaker, etc.)
Has a cardiac arrhythmia
Has open skin sores over area of TENS placement
Not planning to have surgery or hormonal medication changes during the study
Pregnant
Pain Management, Women's Health
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See this study on ClinicalTrials.gov
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Location Contacts
Hershey, PA ,