Status:
RECRUITING
NIRS for the Diagnosis of Myofascial Pelvic Pain
Lead Sponsor:
University of California, Los Angeles
Collaborating Sponsors:
National Center for Complementary and Integrative Health (NCCIH)
Conditions:
Myofascial Pelvic Pain
Eligibility:
FEMALE
18+ years
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 como...
Detailed Description
DETAILED DESCRIPTION Introduction. Myofascial pelvic pain (MPP) is the predominant underlying cause in 60-90% of women with chronic pelvic pain. MPP can be debilitating, and is often associated with b...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 23 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT07181447
Start Date
January 23 2025
End Date
September 1 2026
Last Update
September 23 2025
Active Locations (1)
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1
UCLA Center for Women's Pelvic Health
Los Angeles, California, United States, 90095