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

Sponsor

Loyola University (Other)

Overall Status

Recruiting

CT.gov ID

NCT05750212

Collaborator

(none)

208

Enrollment

Location

Anticipated Duration (Months)

14.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Chronic Pelvic Pain Syndrome	Diagnostic Test: Tone Diagnostic Test: Tenderness Diagnostic Test: Contraction Diagnostic Test: Relaxation Diagnostic Test: Electromyography Diagnostic Test: Transperineal Diagnostic Test: Pressure

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

208 participants

Observational Model:

Case-Control

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Jan 24, 2023

Anticipated Primary Completion Date :

Jan 24, 2024

Anticipated Study Completion Date :

Mar 24, 2024

Arms and Interventions

Arm	Intervention/Treatment
Cases Cases are adult female patients with a diagnosis of pelvic floor disorder.	Diagnostic Test: Tone Tone is a binary measurement of the pelvic floor muscle on physical examination Diagnostic Test: Tenderness Tenderness is a binary measurement of the pelvic floor muscle on physical examination Diagnostic Test: Contraction Contraction is a binary measurement of the pelvic floor muscle on physical examination Diagnostic Test: Relaxation Relaxation is a binary measurement of the pelvic floor muscle on physical examination Diagnostic Test: Electromyography Electromyography is a measurement of the pelvic floor muscle in microvolts Diagnostic Test: Transperineal Transperineal measurements (in millimeters) of the pelvic floor muscle using an ultrasound Diagnostic Test: Pressure Pressure measurements (in millimeters) of the pelvic floor muscle using an algometer
Controls Controls are adult female patients sampled from an outpatient primary care center	Diagnostic Test: Tone Tone is a binary measurement of the pelvic floor muscle on physical examination Diagnostic Test: Tenderness Tenderness is a binary measurement of the pelvic floor muscle on physical examination Diagnostic Test: Contraction Contraction is a binary measurement of the pelvic floor muscle on physical examination Diagnostic Test: Relaxation Relaxation is a binary measurement of the pelvic floor muscle on physical examination Diagnostic Test: Electromyography Electromyography is a measurement of the pelvic floor muscle in microvolts Diagnostic Test: Transperineal Transperineal measurements (in millimeters) of the pelvic floor muscle using an ultrasound Diagnostic Test: Pressure Pressure measurements (in millimeters) of the pelvic floor muscle using an algometer

Arm

Intervention/Treatment

Cases

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

Diagnostic Test: Tone

Tone is a binary measurement of the pelvic floor muscle on physical examination

Diagnostic Test: Tenderness

Tenderness is a binary measurement of the pelvic floor muscle on physical examination

Diagnostic Test: Contraction

Contraction is a binary measurement of the pelvic floor muscle on physical examination

Diagnostic Test: Relaxation

Relaxation is a binary measurement of the pelvic floor muscle on physical examination

Diagnostic Test: Electromyography

Electromyography is a measurement of the pelvic floor muscle in microvolts

Diagnostic Test: Transperineal

Transperineal measurements (in millimeters) of the pelvic floor muscle using an ultrasound

Diagnostic Test: Pressure

Pressure measurements (in millimeters) of the pelvic floor muscle using an algometer

Controls

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

Diagnostic Test: Tone

Tone is a binary measurement of the pelvic floor muscle on physical examination

Diagnostic Test: Tenderness

Tenderness is a binary measurement of the pelvic floor muscle on physical examination

Diagnostic Test: Contraction

Contraction is a binary measurement of the pelvic floor muscle on physical examination

Diagnostic Test: Relaxation

Relaxation is a binary measurement of the pelvic floor muscle on physical examination

Diagnostic Test: Electromyography

Electromyography is a measurement of the pelvic floor muscle in microvolts

Diagnostic Test: Transperineal

Transperineal measurements (in millimeters) of the pelvic floor muscle using an ultrasound

Diagnostic Test: Pressure

Pressure measurements (in millimeters) of the pelvic floor muscle using an algometer

Outcome Measures

Primary Outcome Measures

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).

Eligibility Criteria

Criteria

Ages Eligible for Study:

21 Years to 80 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Loyola Medical Center	Maywood	Illinois	United States	60153

Sponsors and Collaborators

Loyola University

Investigators

Principal Investigator: Colleen Fitzgerald, MD, Loyola Medical Center

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Colleen M. Fitzgerald, MD, MS, Principal Investigator, Loyola University

ClinicalTrials.gov Identifier:

NCT05750212

Other Study ID Numbers:

213778

First Posted:

Mar 1, 2023

Last Update Posted:

Mar 1, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Pelvic Pain

Study Results

No Results Posted as of Mar 1, 2023