Measuring Pelvic Floor Muscle Fitness Before and After Treatment
Not yet recruitingNot applicableNCT07605598
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
This study is being done to better understand and improve treatment for myofascial pelvic pain, a common cause of long-lasting pelvic pain in women. Myofascial pelvic pain is related to tight or dysfunctional pelvic floor muscles and can cause pain as well as bladder, bowel, and sexual problems. Current clinical evaluations mostly rely on physical examination and patient-reported symptoms and do not fully measure how the pelvic floor muscles are functioning. The purpose of this study is to measure pelvic floor muscle function using a noninvasive imaging method called near-infrared spectroscopy, or NIRS. This method measures changes in muscle blood flow and oxygen levels during muscle contraction and relaxation. The study will examine whether pelvic floor muscle function improves after different treatments and whether these physiologic changes are associated with improvements in pain and symptoms. The study will enroll 120 adult women who have had pelvic pain for at least three months and have pelvic floor muscle tenderness on examination. Participants will be randomly assigned to one of three groups: education with relaxation exercises, pelvic floor physical therapy focused on myofascial release, or vaginal medication used to help relax pelvic floor muscles. Participants will take part in four study visits over a six-month period. During these visits, they will complete questionnaires about pain and pelvic symptoms, undergo pelvic floor examinations, and have pelvic floor muscle imaging using the NIRS device while performing brief muscle contractions and relaxations. Some visits will also include collection of blood, urine, and vaginal samples to measure inflammation. The information gained from this study may help improve the diagnosis and treatment of myofascial pelvic pain by providing objective measures of pelvic floor muscle function and identifying which treatments are most effective for different patients.
Study details
- Official title
- Quantitative Assessment of Pelvic Floor Muscle Fitness in Myofascial Pelvic Pain Before and After Myofascially-Directed Therapies
- Conditions
- Myofacial Pain
- Pelvic Pain
- Myofascial Pelvic Pain
- Chronic Pelvic Pain
- Interventions
- Diagnostic test: Near Infrared Imaging
- Sponsor
- University of California, Los Angeles
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Start date
- 2026-09-01
- Primary completion
- 2028-09-01
- Sex
- Female
- Age range
- from 18 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: Women over 18 years of age Pelvic Pain for more than 3 months 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 treatment 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®) in the past 6 months Active UTI or vaginal infection Pregnancy or childbirth in the past 12 months, currently planning a pregnancy Illicit Drug addiction/regular use of controlled substances (including marijuana use in the past 2 weeks or during the study period) Pelvic floor physical therapy in the past 3 months Malignancy or other serious medical condition (e.g., poorly controlled diabetes \[HgA1c \> 8\], chronic renal disease \[GFR \<30\], neurologic or rheumatic disease) Diagnosed with an alternate cause of pelvic pain (e.g., ulcerative interstitial cystitis, vestibulodynia, vulvar dermatoses, dysmenorrhea) Urinary retention with a PVR \>150 mL Greater than stage 3 pelvic organ prolapse Indwelling vaginal devices (e.g., pessary, contraceptive ring. Not including Mirena IUD) that cannot be removed for the study Inability to sign an informed consent, fill out questionnaires, or complete study interviews
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT07605598