Musculoskeletal and Pelvic Floor Health in Female Chronic Overlapping Pelvic Pain Conditions

Chronic Pelvic Pain Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05750212
• Other study ID #: 213778
• Status: Recruiting
• Start date: January 24, 2023
• Est. completion date: October 24, 2024

Study information

• Verified date: March 2024
• Source: Loyola University
• Contact: Mary J Tulke, RN
• Phone: 7082162067
• Email: mtulke[@]luc.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Recruiting
• Enrollment: 208
• Est. completion date: October 24, 2024
• Est. primary completion date: September 24, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years to 80 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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.

Related Conditions & MeSH terms

• Chronic Pelvic Pain Syndrome
• Pelvic Pain

Intervention

Diagnostic Test:
• Tone
Tone is a binary measurement of the pelvic floor muscle on physical examination
• Tenderness
Tenderness is a binary measurement of the pelvic floor muscle on physical examination
• Contraction
Contraction is a binary measurement of the pelvic floor muscle on physical examination
• Relaxation
Relaxation is a binary measurement of the pelvic floor muscle on physical examination
• Electromyography
Electromyography is a measurement of the pelvic floor muscle in microvolts
• Transperineal
Transperineal measurements (in millimeters) of the pelvic floor muscle using an ultrasound
• Pressure
Pressure measurements (in millimeters) of the pelvic floor muscle using an algometer

Locations

Country	Name	City	State
United States	Loyola Medical Center	Maywood	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Loyola University

Country where clinical trial is conducted

United States, 

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* Note: There are 102 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in two receiver operating characteristic curves	The delta value between two diagnostic accuracy statistics (c-statistics) will be reported with its 95% confidence interval and significance value (p-value).	0 Days