Near-infrared scanning to help diagnose myofascial pelvic pain

Quantitative Assessment of Pelvic Floor Muscle Fitness in Myofascial Pelvic Pain

This test uses near-infrared measurements of pelvic floor muscle oxygen changes during contractions to help diagnose myofascial pelvic pain in adult women with chronic pelvic pain.

Quick facts

• Study type: Observational
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: University of California, Los Angeles (Academic / other)
• Locations: 1 site (Los Angeles, California)
• Trial ID: NCT07181447 on ClinicalTrials.gov

What this trial studies

This observational study will use near-infrared spectroscopy (NIRS) to record oxygenation and hemodynamic changes in the pelvic floor muscles during standardized contractions. Researchers will develop a normal range based on intra-day (test-to-test) reliability in healthy controls and compare those values with women who have clinically confirmed myofascial pelvic pain. The study will correlate quantitative NIRS signals with pelvic floor exam findings and symptom patterns, and will follow participants prospectively to see whether baseline NIRS data predict response to treatment. The primary goal is to create objective, reproducible physiologic measures to support diagnosis and guide care for MPP.

Who should consider this trial

Good fit: Adult women (18–100) with pelvic pain lasting more than 6 months, average daily pain of at least 4/10, and palpable internal pelvic floor trigger points who can attend clinic visits are ideal candidates.

Not a fit: Women with an alternative diagnosed cause of pelvic pain (such as interstitial cystitis or vestibulodynia), recent childbirth or recent invasive pelvic procedures, active infections, pregnancy, or serious uncontrolled medical conditions are unlikely to benefit from the diagnostic approach tested here.

Why it matters

Potential benefit: If successful, this could provide a noninvasive, objective test to improve diagnosis and treatment selection for women with myofascial pelvic pain.

How similar studies have performed: While NIRS has been used to study skeletal muscle oxygenation in other settings, applying NIRS to pelvic floor diagnostics is novel and has limited prior clinical validation.

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

Where this trial is running

Los Angeles, California

• UCLA Center for Women's Pelvic Health — Los Angeles, California, United States (Recruiting)

Study contacts

• Study coordinator: Keila Kimura

Conditions Myofascial Pelvic Pain; pelvic pain