Actively Recruiting

Age: 18Years +
FEMALE
Healthy Volunteers
NCT07181447

NIRS for the Diagnosis of Myofascial Pelvic Pain

Led by University of California, Los Angeles · Updated on 2025-09-23

110

Participants Needed

1

Research Sites

83 weeks

Total Duration

On this page

Sponsors

U

University of California, Los Angeles

Lead Sponsor

N

National Center for Complementary and Integrative Health (NCCIH)

Collaborating Sponsor

AI-Summary

What this Trial 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. 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.

CONDITIONS

Official Title

NIRS for the Diagnosis of Myofascial Pelvic Pain

Who Can Participate

Age: 18Years +
FEMALE
Healthy Volunteers

Eligibility Criteria

Eligible

You may qualify if you...

  • 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
Not Eligible

You will not qualify if you...

  • Inability to participate in clinic visits
  • Prior invasive pelvic procedures for pain (e.g., prior pelvic surgery, sacral neuromodulation, intradetrusor Botox�ae)
  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

UCLA Center for Women's Pelvic Health

Los Angeles, California, United States, 90095

Actively Recruiting

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Research Team

K

Keila Kimura

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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