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Use of TENS Unit in the Management of Endometriosis Pain

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ClinicalTrials.gov Identifier: NCT05348005
Recruitment Status : Recruiting
First Posted : April 27, 2022
Last Update Posted : August 1, 2022
Sponsor:
Information provided by (Responsible Party):
Kristin Riley, MD, Milton S. Hershey Medical Center

Study Description
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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 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.


Condition or disease Intervention/treatment Phase
Endometriosis Pelvic Pain Device: Ovira Transcutaneous Electrical Nerve Stimulation Unit Not Applicable

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-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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention 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)
Primary Purpose: Supportive Care
Official Title: A Cross-Over Study of the Use of Transcutaneous Electrical Nerve Stimulation Unit in the Management of Endometriosis Pain
Actual Study Start Date : July 28, 2022
Estimated Primary Completion Date : March 1, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
No Intervention: No TENS unit use
All subjects will start with 3 months of no TENS use and diary tracking
Active Comparator: TENS unit use
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Change in Average Daily VAS Pain Score [ Time Frame: Baseline Period (months 1-3) and Treatment Period (months 4-6) ]
    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).


Secondary Outcome Measures :
  1. Change in Quality of Life Score from baseline to end of study using the EHP30 questionnaire [ Time Frame: Baseline and 6 months ]
    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).

  2. Change in Female Sexual Function Index Total Score using the FSFI questionnaire [ Time Frame: Baseline and 6 months ]
    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).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05348005


Contacts
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Contact: Linda Li, MD 7175310003 ext 286762 lindali@pennstatehealth.psu.edu

Locations
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United States, Pennsylvania
Penn State Health Milton S. Hershey Medical Center Recruiting
Hershey, Pennsylvania, United States, 17033
Contact: Linda Li, MD    717-531-0003 ext 286762    lindali@pennstatehealth.psu.edu   
Contact: Amyee McMonagle    7175314484      
Sub-Investigator: Linda Li, MD         
Principal Investigator: Kristin Riley, MD         
Sponsors and Collaborators
Milton S. Hershey Medical Center
Investigators
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Principal Investigator: Kristin W Riley, MD Penn State Health Hershey Medical Center
More Information
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Publications of Results:

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Responsible Party: Kristin Riley, MD, Assistant Professor, Obstetrics and Gynecology; Interim Chief, Minimally Invasive Gynecologic Surgery; Fellowship Program Director, Minimally Invasive Gynecologic Surgery, Milton S. Hershey Medical Center
ClinicalTrials.gov Identifier: NCT05348005    
Other Study ID Numbers: STUDY00019024
First Posted: April 27, 2022    Key Record Dates
Last Update Posted: August 1, 2022
Last Verified: July 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No
Additional relevant MeSH terms:
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Endometriosis
Pelvic Pain
Pain
Neurologic Manifestations