RECRUITING

Transvaginal Electrical Stimulation for Myofascial Pelvic Pain

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Conditions

Myofascial Pelvic Painhigh frequency transvaginal electrical stimulationpelvic floorchronic pelvic painmuscle fatigue

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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

Myofascial Pelvic Pain (MPP) is a frequently overlooked musculoskeletal cause of chronic pelvic pain affecting 10-20% of all adult women. Despite high prevalence and societal costs, few effective treatments exist and are difficult to access due to shortages of skilled personnel. Treatments for MPP using electrical stimulation to induce muscle fatigue have proven efficacy at reducing pain, improving circulation, and promoting tissue healing, but have proven difficult to implement in gynecologic practice. The aim of this three-arm randomized study is to evaluate the utility of transvaginal electrical stimulation at a fixed frequency of 200 Hz in women with symptomatic MPP in comparison to the standard, first-line treatment with education, stretching, and low-impact exercise. Nursing staff without prior training will be taught to deliver this high-frequency transvaginal electrical stimulation (HF-TES) treatment using the device. Responses to treatment provided by a specialist physician and licensed vocational nurse will be compared. Patients with \>50% pain improvement will determine the effectiveness of HF-TES. Responses to treatment provided by a specialist physician and licensed vocational nurse will also be compared. Participants will be followed for 3 months following treatment completion.

Official Title

Repurposing Pelvic Floor Electrical Stimulation for the Treatment of Chronic Pelvic Pain

Quick Facts

Study Start:2022-10-31
Study Completion:2025-12
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05354869

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 65 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Women between 18 and 65 years of age
  2. * Pelvic pain for more than 6 months duration
  3. * Report an average daily pain intensity score of at least 4 (on a 0 to 10 scale)
  4. * Palpable trigger points in internal pelvic floor muscles on standardized myofascial pelvic floor exam
  5. * Willing to refrain from new clinical treatments that may affect pain during the study period
  1. * Inability to participate in weekly clinic visits
  2. * Prior invasive pelvic procedures for pain (e.g., prior pelvic surgery, sacroiliac joint injections, ganglion impar block, bladder instillations, sacral neuromodulation, intradetrusor or intramuscular Botox®)
  3. * Active urinary tract infection (UTI) or vaginal infection
  4. * Pregnancy, childbirth during the previous12 months, currently planning pregnancy
  5. * Drug addiction
  6. * Prior pelvic floor physical therapy
  7. * Malignancy or other serious medical condition (e.g., poorly controlled diabetes \[Glycated hemoglobin (HgA1c) \> 8\], neurologic or rheumatic disease)
  8. * Diagnosed with an alternate cause of pelvic pain (e.g., interstitial cystitis, dysmenorrhea/menorrhalgia, vestibulodynia, vulvar dermatoses)
  9. * Urinary retention
  10. * Greater than stage 3 pelvic organ prolapse
  11. * Indwelling vaginal devices (e.g., vaginal pessary, contraceptive ring)
  12. * Inability to sign an informed consent, fill out questionnaires, or complete study interviews

Contacts and Locations

Study Contact

A. Lenore Ackerman, MD, PhD
CONTACT
833-825-2974
aackerman@mednet.ucla.edu
Nasaura Richard, MPH
CONTACT
3107944321
nrichard@mednet.ucla.edu

Principal Investigator

A. Lenore Ackerman, MD, PhD
PRINCIPAL_INVESTIGATOR
University of California, Los Angeles

Study Locations (Sites)

UCLA Center for Women's Pelvic Health
Los Angeles, California, 90095
United States

Collaborators and Investigators

Sponsor: University of California, Los Angeles

  • A. Lenore Ackerman, MD, PhD, PRINCIPAL_INVESTIGATOR, University of California, Los Angeles

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 Date2022-10-31
Study Completion Date2025-12

Study Record Updates

Study Start Date2022-10-31
Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

  • high frequency transvaginal electrical stimulation
  • pelvic floor
  • chronic pelvic pain
  • muscle fatigue

Additional Relevant MeSH Terms

  • Myofascial Pelvic Pain