Musculoskeletal and Pelvic Floor Health in Female Chronic Overlapping Pelvic Pain Conditions
- Conditions
- Chronic Pelvic Pain Syndrome
- Interventions
- Diagnostic Test: ToneDiagnostic Test: TendernessDiagnostic Test: ContractionDiagnostic Test: RelaxationDiagnostic Test: ElectromyographyDiagnostic Test: TransperinealDiagnostic Test: Pressure
- Registration Number
- NCT05750212
- Lead Sponsor
- Loyola University
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 208
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cases Tenderness Cases are adult female patients with a diagnosis of pelvic floor disorder. Cases Contraction Cases are adult female patients with a diagnosis of pelvic floor disorder. Controls Relaxation Controls are adult female patients sampled from an outpatient primary care center Cases Relaxation Cases are adult female patients with a diagnosis of pelvic floor disorder. Cases Transperineal Cases are adult female patients with a diagnosis of pelvic floor disorder. Controls Tenderness Controls are adult female patients sampled from an outpatient primary care center Controls Electromyography Controls are adult female patients sampled from an outpatient primary care center Controls Transperineal Controls are adult female patients sampled from an outpatient primary care center Cases Tone Cases are adult female patients with a diagnosis of pelvic floor disorder. Controls Contraction Controls are adult female patients sampled from an outpatient primary care center Cases Electromyography Cases are adult female patients with a diagnosis of pelvic floor disorder. Cases Pressure Cases are adult female patients with a diagnosis of pelvic floor disorder. Controls Pressure Controls are adult female patients sampled from an outpatient primary care center Controls Tone Controls are adult female patients sampled from an outpatient primary care center
- Primary Outcome Measures
Name Time Method Difference in two receiver operating characteristic curves 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).
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Loyola Medical Center
🇺🇸Maywood, Illinois, United States