Using TENS units to manage endometriosis pain
A Cross-Over Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain
This study is testing if using TENS units can help people with endometriosis feel less pain during flare-ups.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 45 Years |
| Sex | Female |
| Sponsor | Milton S. Hershey Medical Center Academic / other |
| Locations | 1 site (Hershey, Pennsylvania) |
| Trial ID | NCT05348005 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of Transcutaneous Electrical Nerve Stimulator (TENS) units in reducing pain associated with endometriosis flare-ups. Participants will first undergo a 3-month baseline period without TENS unit use, during which they will record their pain levels, medication use, and bleeding patterns. After this period, they will use the TENS unit for another 3 months while continuing to document their experiences in an online diary. The study aims to determine if TENS units can provide significant pain relief for individuals suffering from endometriosis.
Who should consider this trial
Good fit: Ideal candidates are females aged 18-45 with a surgical diagnosis of endometriosis and experiencing average monthly pain flare-ups.
Not a fit: Patients with implantable devices, recent surgeries, or those who are pregnant or nursing may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a non-invasive pain management option for patients with endometriosis.
How similar studies have performed: While the use of TENS units for pain management is established, this specific application for endometriosis is relatively novel and has not been extensively tested.
Eligibility criteria
Show full inclusion / exclusion 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 \<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
Where this trial is running
Hershey, Pennsylvania
- Penn State Health Milton S. Hershey Medical Center — Hershey, Pennsylvania, United States (Recruiting)
Study contacts
- Principal investigator: Kristin W Riley, MD — Penn State Health Hershey Medical Center
- Study coordinator: Linda Li, MD
- Email: lindali@pennstatehealth.psu.edu
- Phone: 7175310003
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.