NCT07181447 NIRS for the Diagnosis of Myofascial Pelvic Pain
| NCT ID | NCT07181447 |
| Status | Recruiting |
| Phase | — |
| Sponsor | University of California, Los Angeles |
| Condition | Myofascial Pelvic Pain |
| Study Type | OBSERVATIONAL |
| Enrollment | 110 participants |
| Start Date | 2025-01-23 |
| Primary Completion | 2026-07-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 110 participants in total. It began in 2025-01-23 with a primary completion date of 2026-07-01.
⚠ 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 an often-misdiagnosed condition affecting up to 26% of women during their lives and imposing enormous costs on national health care systems. It frequently involves comorbidities such as bladder, bowel, and sexual dysfunction. There are no quantitative measures that adequately guide the physician and accurate diagnosis typically requires an internal examination by a tertiary specialist. This study will develop and test an instrument to establish a normal range for near infrared spectroscopy (NIRS) optical changes associate with pelvic floor exercise in adult women based on the test-to test (intra-day) reliability of oxygen kinetics related to contraction of the pelvic floor muscle. We will establish the relationship between the quantitative NIRS data, the condition of Myofascial pelvic musculature and the symptomatology of MPP and related comorbidities. We will also evaluate prospectively the effectiveness of these data in predicting effective treatment modalities. Finally, we will optimize a training regime for non-specialists to allow this technique to be used in a variety of settings. The development of this device and validation of its relevance to diagnosis and treatment of MPP will provide effective care sooner and at a lower cost than current procedures. It will also reduce inequities in the availability of care to underserved populations by providing an inexpensive, reliable and easily available method for a variety of providers to address MPP.
Eligibility Criteria
Inclusion Criteria: * Women between 18 and 100 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/tender 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 clinic visits * Prior invasive pelvic procedures for pain (e.g., prior pelvic surgery, sacral neuromodulation, intradetrusor Botox®) * Active UTI or vaginal infection * Pregnancy, childbirth during the previous 12 months, currently planning pregnancy * Illicit Drug addiction/regular use of controlled substances * Malignancy or other serious medical condition (e.g., poorly controlled diabetes \[HgA1c \> 8\], neurologic or rheumatic disease) * Diagnosed with an alternate cause of pelvic pain (e.g., interstitial cystitis, vestibulodynia, vulvar dermatoses dysmenorrhea) * Urinary retention * Greater than stage 3 pelvic organ prolapse * Indwelling vaginal devices (e.g., pessary, contraceptive ring) * Inability to sign an informed consent, fill out questionnaires, or complete study interviews
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07181447 clinical trial?
This trial is open to female participants only, aged 18 Years or older, 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 NCT07181447 currently recruiting?
Yes, NCT07181447 is actively recruiting participants. Contact the research team at bladderpainucla@gmail.com for enrollment information.
Where is the NCT07181447 trial being conducted?
This trial is being conducted at Los Angeles, United States.
Who is sponsoring the NCT07181447 clinical trial?
NCT07181447 is sponsored by University of California, Los Angeles. The trial plans to enroll 110 participants.