NCT05354869 Transvaginal Electrical Stimulation for Myofascial Pelvic Pain
| NCT ID | NCT05354869 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Myofascial Pelvic Pain |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2022-10-31 |
| Primary Completion | 2026-12 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2022-10-31 with a primary completion date of 2026-12.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Women between 18 and 65 years of age * Pelvic pain for more than 6 months duration * Report an average daily pain intensity score of at least 4 (on a 0 to 10 scale) * Palpable trigger points in internal pelvic floor muscles on standardized myofascial pelvic floor exam * Willing to refrain from new clinical treatments that may affect pain during the study period Exclusion Criteria: * Inability to participate in weekly clinic visits * 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®) * Active urinary tract infection (UTI) or vaginal infection * Pregnancy, childbirth during the previous12 months, currently planning pregnancy * Drug addiction * Prior pelvic floor physical therapy * Malignancy or other serious medical condition (e.g., poorly controlled diabetes \[Glycated hemoglobin (HgA1c) \> 8\], neurologic or rheumatic disease) * Diagnosed with an alternate cause of pelvic pain (e.g., interstitial cystitis, dysmenorrhea/menorrhalgia, vestibulodynia, vulvar dermatoses) * Urinary retention * Greater than stage 3 pelvic organ prolapse * Indwelling vaginal devices (e.g., vaginal pessary, contraceptive ring) * Inability to sign an informed consent, fill out questionnaires, or complete study interviews
Contact & Investigator
A. Lenore Ackerman, MD, PhD
PRINCIPAL INVESTIGATOR
University of California, Los Angeles
Frequently Asked Questions
Who can join the NCT05354869 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 65 Years, studying Myofascial Pelvic Pain. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT05354869 currently recruiting?
Yes, NCT05354869 is actively recruiting participants. Contact the research team at aackerman@mednet.ucla.edu for enrollment information.
Where is the NCT05354869 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT05354869 clinical trial?
NCT05354869 is sponsored by University of California, Los Angeles. The principal investigator is A. Lenore Ackerman, MD, PhD at University of California, Los Angeles. The trial plans to enroll 60 participants.