Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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-month "baseline" period (no TENS unit use for endometriosis flares) and then cross-over to a 3-month "treatment" period (TENS unit use for endometriosis flares). Potential subjects will be pre-screened in the Penn State Minimally Invasive GYN (MIGS) Surgery Clinic for pathologically diagnosed endometriosis and from the Penn State MIGS endometriosis database. Potential subjects will then be called to evaluate the remainder of the inclusion and exclusion criteria. If fulfilled, potential subjects will follow up at the enrollment visit (Visit 1) where consent is reviewed and signed. The baseline QOL and FSFI REDCap surveys will be completed at this visit. Subjects will be set up to receive automated links to complete diary entries and surveys directly in REDCap. Prior to initiating TENS unit use for endometriosis flare-related pain, subjects will record daily entries into RedCap during episodes of endometriosis flares for 3 months. Each entry will record their VAS pain score as well as medication intake and bleeding profile. Subjects will then be mailed the TENS unit at the 3 months mark into the study. Subjects will then complete entries with TENS use at their discretion for the following 3 months and record TENS unit use duration, frequency, and side effects in addition to the documentation of pain, medication and bleeding. At the end of the study, subjects will complete a QOL and FSFI survey. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT05348005
Study type Interventional
Source Milton S. Hershey Medical Center
Contact Linda Li, MD
Phone 7175310003
Email lindali@pennstatehealth.psu.edu
Status Recruiting
Phase N/A
Start date July 28, 2022
Completion date January 1, 2025

See also
  Status Clinical Trial Phase
Completed NCT01931670 - A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain Phase 3
Recruiting NCT05648669 - A Study to Evaluate Safety and Efficacy of Elagolix in Patients With Moderate to Severe Endometriosis-Associated Pain Phase 3
Completed NCT04081532 - The Effectiveness of Laparoscopic Treatment of Superficial Endometriosis for Managing Chronic Pelvic Pain N/A
Recruiting NCT06101303 - Endometriosis Pain
Completed NCT04665414 - Diagnosis of Adenomyosis Using Ultrasound, Elastography and MRI
Completed NCT03690765 - Study of Real Clinical Practice to Evaluate the Effects of Oral Dydrogesterone for Treatment of Confirmed Endometriosis
Recruiting NCT05153512 - ADOlescent DysmenoRrhea Endometriosis Assessment Magnetic Resonance Imaging (Adodream)
Active, not recruiting NCT04171297 - Ultrasound Evaluation of the Pelvis in Women With Suspected Endometriosis Scheduled for Laparoscopic Surgery
Recruiting NCT04172272 - The Influence of TAP Block in the Control of Postoperative Pain After Laparotomy for Gynecological Procedures N/A
Completed NCT04565470 - Strategies of Self-management of Endometriosis Symptoms
Completed NCT03613298 - Treatment by HIFU With Focal One® of Posterior Deep Infiltrating Endometriosis Lesions With Intestinal Involvement. N/A
Withdrawn NCT05568940 - Evaluating Tibolone Add-back in Patients With Endometriosis and Fibroids
Not yet recruiting NCT03464799 - Does Immunotherapy Have a Role in the Management of Endometriosis?
Active, not recruiting NCT03002870 - Characteristics of Patient Population With Endometriosis N/A
Completed NCT02973854 - Activation of the Sphingosine-1-phosphate (S1P) to S1P1 Receptor Subtype (S1PR1) Axis in Patients With Endometriosis: Identification of Potential Relevant Biomarkers to Diagnose and Treat
Withdrawn NCT03272360 - Endometriosis Biomarker Discovery Study N/A
Recruiting NCT02481739 - Laparoscopic Surgical Management of Endometriosis on Fertility N/A
Active, not recruiting NCT02754648 - Three Different Laparoscopic Approaches for Ovarian Endometrioma and the Effect on Ovarian Reserve N/A
Completed NCT06106932 - GnRH-a on Angiogenesis of Endometriosis N/A
Completed NCT02387931 - Supplementation in Adolescent Girls With Endometriosis Phase 4