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

March 6, 2025 updated by: Colleen M. Fitzgerald, MD, MS, Loyola University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Estimated)

208

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Mary J Tulke, RN
  • Phone Number: 7082162067
  • Email: mtulke@luc.edu

Study Contact Backup

Study Locations

  • United States
    • Illinois
      • Maywood, Illinois, United States, 60153
        • Recruiting
        • Loyola Medical Center
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Participants are selected from a tertiary medical care center

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Difference in two receiver operating characteristic curves
Time Frame: 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).
0 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Loyola University

Investigators

  • Principal Investigator: Colleen Fitzgerald, MD, Loyola Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 24, 2023

Primary Completion (Estimated)

September 24, 2025

Study Completion (Estimated)

October 24, 2025

Study Registration Dates

First Submitted

January 20, 2023

First Submitted That Met QC Criteria

February 20, 2023

First Posted (Actual)

March 1, 2023

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

March 6, 2025

Last Verified

March 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 213778

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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