NCT07181447 · University of California, Los Angeles
NIRS for the Diagnosis of Myofascial Pelvic Pain
What this study is about
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.
View original scientific description
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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Los Angeles, California
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 23, 2025 · Source of record for eligibility and locations