COMPLETED

Use of TENS Unit in the Management of Endometriosis Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-07-28
Study Completion:2025-07-16
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:COMPLETED

Study ID

NCT05348005

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 45 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Females ages 18-45 years at time of enrollment
  2. 2. A surgical diagnosis with direct visualization and/or histopathologic confirmation of endometriosis
  3. 3. Average monthly endometriosis pain flare
  4. 4. Naïve TENS user
  1. 1. TENS device exclusion:
  2. 1. Implantable devices (pacemaker, Interstim, etc.)
  3. 2. Cardiac arrhythmia
  4. 3. Open skin sores over areas of placement
  5. 2. Pregnancy
  6. 3. Nursing or trying to conceive at this time
  7. 4. Post-operative \<12 weeks from abdominal or pelvic surgery
  8. 5. Planned surgery or hormonal medication changes for duration of study if applicable
  9. 6. Non-English speaking or inability to read and understand English
  10. 7. Prisoners

Contacts and Locations

Principal Investigator

Kristin W Riley, MD
PRINCIPAL_INVESTIGATOR
Penn State Health Hershey Medical Center

Study Locations (Sites)

Penn State Health Milton S. Hershey Medical Center
Hershey, Pennsylvania, 17033
United States

Collaborators and Investigators

Sponsor: Milton S. Hershey Medical Center

  • Kristin W Riley, MD, PRINCIPAL_INVESTIGATOR, Penn State Health Hershey Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-07-28
Study Completion Date2025-07-16

Study Record Updates

Study Start Date2022-07-28
Study Completion Date2025-07-16

Terms related to this study

Additional Relevant MeSH Terms

  • Endometriosis
  • Pelvic Pain