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临床试验/NCT05750212
NCT05750212已完成不适用

Musculoskeletal and Pelvic Floor Health in Female Chronic Overlapping Pelvic Pain Conditions (The MSK-PELVIC Study)

Loyola University2 个研究点 分布在 1 个国家目标入组 98 人开始时间: 2023年1月24日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
98
试验地点
2
主要终点
Difference in two receiver operating characteristic curves

研究概览

简要总结

The purpose of this study is to learn about nerve function and pelvic muscle function. To do this we will compare the pelvic nerve and muscle function of women with chronic pelvic pain to those who do not have chronic pelvic pain. Understanding the pain may lead to better treatments in the future.

详细描述

Chronic pelvic pain (CPP) may affect up to a quarter of all women. Traditionally, CPP has been thought to be driven by visceral pain mechanisms such as Interstitial Cystitis/Painful Bladder Syndrome (IC/PBS), Irritable bowel syndrome (IBS) and endometriosis. It is also established that these visceral pain conditions overlap with vulvodynia, fibromyalgia, depression, and anxiety. More recently, underlying pelvic floor myofascial (PFMP) and dyssynergia have been identified as additional overlapping CPP conditions. Prior work suggests PFMP may be a viscero-somatic response, however, PFMP as a compensatory consequence of other regional musculoskeletal (MSK) conditions has also been proposed. Indeed, across their lifespan, women face higher risks than men for a plethora of MSK injuries and chronic MSK conditions, including an increased prevalence of sports-related injuries, joint hypermobility, fibromyalgia, osteoarthritic conditions (post-menopause), and osteoporosis/osteoporosis-associated fractures. These elevated risks are thought to be due to the unique anatomic (structural), biomechanical, and hormonal factors that can be attributed to the physiologic process of pregnancy and aging. The current application aims to address the significant knowledge gap regarding the limited understanding of the neuromuscular function of the PFM in CPP as well as the role of overlapping MSK conditions and MSK health that may be influencing PFM response. The short-term goal is to examine PFM biomechanics by identifying the most precise muscle measures in women with CPP of various overlapping diagnoses compared to asymptomatic controls, along with assessing overall MSK health/physical activity. The long-term goal is to determine MSK pelvic pain mechanisms that will inform clinically relevant classification, develop evidence-based non-pharmacologic (physical therapy/exercise) treatments for women with CPP, and advance research tools in the area of PFM function and CPP as it relates to overall MSK health. Our innovative strategy combines neuromuscular measures using novel devices and validated measures in evaluating CPP, MSK health, and physical activity. Our central hypothesis is that women with CPP will demonstrate quantifiable PFM abnormalities and clinical MSK characteristics that differ from asymptomatic controls. The results from this study will have a significant public health impact with contributions of rigorous objective and comprehensive PFM and MSK methods, which will be suitable for future NIH clinical research networks/trials, to evaluate and assess the MSK contribution and potential treatment outcomes in women with CPP.

研究设计

研究类型
Observational
观察模型
Case Control
时间视角
Cross Sectional

入排标准

年龄范围
21 Years 至 80 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Female sex
  • Age 21 to 80 years
  • Symptoms of CPP as defined by the American College of Obstetrics & Gynecology (ACOG) for more than 6 months
  • At least two of seven overlapping CPP diagnosis (i.e., IC/PBS, IBS, Endometriosis, Vulvodynia, PN, FM, PFMP)
  • An average CPP pain score of at least three on a 10 point pain scale

排除标准

  • Current or history of GI or GU pelvic cancer
  • Current pelvic infection (e.g., a UTI or vaginal infection)
  • Current or imminent planned pregnancy or recent delivery in the last 6 months
  • Abdominal or pelvic surgery in the last 36 months.

研究组 & 干预措施

Cases

Cases are adult female patients with a diagnosis of pelvic floor disorder.

干预措施: Tone (Diagnostic Test)

Cases

Cases are adult female patients with a diagnosis of pelvic floor disorder.

干预措施: Tenderness (Diagnostic Test)

Cases

Cases are adult female patients with a diagnosis of pelvic floor disorder.

干预措施: Contraction (Diagnostic Test)

Cases

Cases are adult female patients with a diagnosis of pelvic floor disorder.

干预措施: Relaxation (Diagnostic Test)

Cases

Cases are adult female patients with a diagnosis of pelvic floor disorder.

干预措施: Electromyography (Diagnostic Test)

Cases

Cases are adult female patients with a diagnosis of pelvic floor disorder.

干预措施: Transperineal (Diagnostic Test)

Cases

Cases are adult female patients with a diagnosis of pelvic floor disorder.

干预措施: Pressure (Diagnostic Test)

Controls

Controls are adult female patients sampled from an outpatient primary care center

干预措施: Tone (Diagnostic Test)

Controls

Controls are adult female patients sampled from an outpatient primary care center

干预措施: Tenderness (Diagnostic Test)

Controls

Controls are adult female patients sampled from an outpatient primary care center

干预措施: Contraction (Diagnostic Test)

Controls

Controls are adult female patients sampled from an outpatient primary care center

干预措施: Relaxation (Diagnostic Test)

Controls

Controls are adult female patients sampled from an outpatient primary care center

干预措施: Electromyography (Diagnostic Test)

Controls

Controls are adult female patients sampled from an outpatient primary care center

干预措施: Transperineal (Diagnostic Test)

Controls

Controls are adult female patients sampled from an outpatient primary care center

干预措施: Pressure (Diagnostic Test)

结局指标

主要结局

Difference in two receiver operating characteristic curves

时间窗: 0 Days

The delta value between two diagnostic accuracy statistics (c-statistics) will be reported with its 95% confidence interval and significance value (p-value).

次要结局

未报告次要终点

研究者

发起方
Loyola University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Colleen M. Fitzgerald, MD, MS

Principal Investigator

Loyola University

研究点 (2)

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