Use of TENS Unit in the Management of Endometriosis Pain

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Cross-Over Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain

Conditions
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Endometriosis, Pelvic Pain

Intervention / Treatment
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* Device: Ovira Transcutaneous Electrical Nerve Stimulation Unit


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: 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).
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No TENS unit use<br>All subjects will start with 3 months of no TENS use and diary tracking | |
| Active Comparator: TENS unit use<br>All subjects will then have 3 months of TENS use during episodes of endometriosis pain flare and diary tracking. | Device: Ovira Transcutaneous Electrical Nerve Stimulation Unit<br>* TENS units have a wide application from treatment of chronic back pain, chronic abdominal pain, cancer pain, perioperative pain, and labor pain.19-24 TENS units have been shown to be well-tolerated with minimal side effects and have been successful in reducing pain as well as pain medication use in patients with primary dysmenorrhea, which excludes pathology such as endometriosis. 11-18 Certain TENS units have also been FDA approved for the general indication of pelvic pain.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Daily VAS Pain Score | Average daily pain during endometriosis flares will be measured using a Visual Analog Scale (VAS), a horizontal line measuring pain from 0 (no pain) to 100 (worst pain), and compared between the baseline period (no TENS use) and treatment period (TENS use). | Baseline Period (months 1-3) and Treatment Period (months 4-6) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Quality of Life Score from baseline to end of study using the EHP30 questionnaire | Change in quality of life from baseline to end of study using the Endometriosis Health Profile (EHP30) questionnaire. Scores range from 0 (best health status) to 100 (worst health status). | Baseline and 6 months | 
| Change in Female Sexual Function Index Total Score using the FSFI questionnaire | Change in Female Sexual Function Index (FSFI) validated survey scores from baseline to end of study among participants who are currently partnered. FSFI total score ranges from 2.0 (poor) to 36.0 (best). | Baseline and 6 months |