Quantitative Assessment of Pelvic Floor Muscle Fitness in Myofascial Pelvic Pain Before and After Myofascially-Directed Therapies
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 120
- 试验地点
- 1
研究概览
简要总结
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.
详细描述
STUDY OVERVIEW This is a prospective, randomized, controlled clinical study designed to objectively measure pelvic floor muscle (PFM) physiology and inflammatory changes in women with myofascial pelvic pain (MPP). The study uses a novel, transvaginal near-infrared spectroscopy (NIRS) system to assess pelvic floor muscle oxygenation, hemodynamics, and recovery during standardized contraction and relaxation tasks. The overarching goal is to improve objective diagnosis, phenotyping, and personalized treatment of MPP.
Scientific Rationale Myofascial pelvic pain is a common contributor to chronic pelvic pain in women and is characterized by pelvic floor muscle hypertonicity, impaired muscle perfusion, local acidosis, and accumulation of inflammatory mediators. These physiologic abnormalities contribute to pain as well as bladder, bowel, and sexual dysfunction. Current clinical evaluation relies largely on subjective examination and patient-reported symptoms, which limits precision in diagnosis and treatment selection.
Preliminary work has demonstrated that pelvic floor NIRS imaging can reliably distinguish women with MPP from asymptomatic controls and can identify physiologic impairments such as reduced muscle oxygenation and delayed recovery following contraction. This study evaluates whether targeted myofascial therapies improve these objective physiologic measures and whether changes in muscle physiology correlate with symptom improvement and inflammatory biomarkers.
STUDY OBJECTIVES
Primary Objective To determine whether pelvic floor muscle fitness, measured using NIRS-derived oxygenation parameters, improves following myofascial-directed treatments in women with MPP.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究者
Anne Lenore Ackerman
Associate Professor of Urology at UCLA, Director of Research, Division of Female Pelvic Medicine and Reconstructive Surgery at UCLA
University of California, Los Angeles