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Chronic Pelvic Pain SyndromeNCT05750212

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

An observational study of Chronic Pelvic Pain Syndrome, run by Loyola University at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 21 to 80 years, women only
Conditions the study is for
Chronic Pelvic Pain Syndrome
What is being tested?
Tone, Tenderness and Contraction
How many people
98 participants
Where
1 siteUnited States
Study dates
24 Jan 2023to 12 Sep 2025
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 80 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Study population: Participants are selected from a tertiary medical care center

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Loyola Medical Center

    Maywood, Illinois, 60153

Other trials in United States

About this study

Official title: 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.

Read the 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.

Being tested
Tone, Tenderness, Contraction, Relaxation, Electromyography

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • ToneDiagnostic test

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

  • TendernessDiagnostic test

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

  • ContractionDiagnostic test

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

  • RelaxationDiagnostic test

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

  • ElectromyographyDiagnostic test

    Electromyography is a measurement of the pelvic floor muscle in microvolts

  • TransperinealDiagnostic test

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

  • PressureDiagnostic test

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

Study groups in NCT05750212
Study groupRoleWhat they receive
CasesCases are adult female patients with a diagnosis of pelvic floor disorder.
Receives: Diagnostic Test: Tone; Diagnostic Test: Tenderness; Diagnostic Test: Contraction; Diagnostic Test: Relaxation; Diagnostic Test: Electromyography; Diagnostic Test: Transperineal; Diagnostic Test: Pressure
ControlsControls are adult female patients sampled from an outpatient primary care center
Receives: Diagnostic Test: Tone; Diagnostic Test: Tenderness; Diagnostic Test: Contraction; Diagnostic Test: Relaxation; Diagnostic Test: Electromyography; Diagnostic Test: Transperineal; Diagnostic Test: Pressure

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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).

    Measured: 0 Days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Mar 2023
  2. Study start24 Jan 2023
  3. Primary completion12 Sep 2025
  4. Study completion12 Sep 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Cross-sectional
Enrolment
98 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05750212
Sponsor's protocol ID
213778
Status last verified
Aug 2026
First submitted
20 Jan 2023
Last updated
31 Aug 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Ahangari A. Prevalence of chronic pelvic pain among women: an updated review. Pain Physician. 2014 Mar-Apr;17(2):E141-7.

    PubMed 24658485
  • Bullones Rodriguez MA, Afari N, Buchwald DS; National Institute of Diabetes and Digestive and Kidney Diseases Working Group on Urological Chronic Pelvic Pain. Evidence for overlap between urological and nonurological unexplained clinical conditions. J Urol. 2013 Jan;189(1 Suppl):S66-74. doi: 10.1016/j.juro.2012.11.019.

    PubMed 23234637
  • Harte SE, Schrepf A, Gallop R, Kruger GH, Lai HHH, Sutcliffe S, Halvorson M, Ichesco E, Naliboff BD, Afari N, Harris RE, Farrar JT, Tu F, Landis JR, Clauw DJ; MAPP Research Network. Quantitative assessment of nonpelvic pressure pain sensitivity in urologic chronic pelvic pain syndrome: a MAPP Research Network study. Pain. 2019 Jun;160(6):1270-1280. doi: 10.1097/j.pain.0000000000001505.

    PubMed 31050659
  • Liu A, Chedid V, Wang XJ, Vijayvargiya P, Camilleri M. Clinical presentation and characteristics of pelvic floor myofascial pain in patients presenting with constipation. Neurogastroenterol Motil. 2020 Jul;32(7):e13845. doi: 10.1111/nmo.13845. Epub 2020 Apr 13.

    PubMed 32281205
  • Lamvu G, Carrillo J, Witzeman K, Alappattu M. Musculoskeletal Considerations in Female Patients with Chronic Pelvic Pain. Semin Reprod Med. 2018 Mar;36(2):107-115. doi: 10.1055/s-0038-1676085. Epub 2018 Dec 19.

    PubMed 30566976
  • Ye AL, Adams W, Westbay LC, Fitzgerald CM. Evaluating Disability-Related Quality of Life in Women With Chronic Pelvic Pain. Female Pelvic Med Reconstr Surg. 2020 Aug;26(8):508-513. doi: 10.1097/SPV.0000000000000771.

    PubMed 31425373
  • Hootman JM, Dick R, Agel J. Epidemiology of collegiate injuries for 15 sports: summary and recommendations for injury prevention initiatives. J Athl Train. 2007 Apr-Jun;42(2):311-9.

    PubMed 17710181
  • Wentz L, Liu PY, Haymes E, Ilich JZ. Females have a greater incidence of stress fractures than males in both military and athletic populations: a systemic review. Mil Med. 2011 Apr;176(4):420-30. doi: 10.7205/milmed-d-10-00322.

    PubMed 21539165
  • Agel J, Arendt EA, Bershadsky B. Anterior cruciate ligament injury in national collegiate athletic association basketball and soccer: a 13-year review. Am J Sports Med. 2005 Apr;33(4):524-30. doi: 10.1177/0363546504269937. Epub 2005 Feb 8.

    PubMed 15722283
  • Gwinn DE, Wilckens JH, McDevitt ER, Ross G, Kao TC. The relative incidence of anterior cruciate ligament injury in men and women at the United States Naval Academy. Am J Sports Med. 2000 Jan-Feb;28(1):98-102. doi: 10.1177/03635465000280012901.

    PubMed 10653551
  • Arendt E, Dick R. Knee injury patterns among men and women in collegiate basketball and soccer. NCAA data and review of literature. Am J Sports Med. 1995 Nov-Dec;23(6):694-701. doi: 10.1177/036354659502300611.

    PubMed 8600737
  • O'Connor KL, Baker MM, Dalton SL, Dompier TP, Broglio SP, Kerr ZY. Epidemiology of Sport-Related Concussions in High School Athletes: National Athletic Treatment, Injury and Outcomes Network (NATION), 2011-2012 Through 2013-2014. J Athl Train. 2017 Mar;52(3):175-185. doi: 10.4085/1062-6050-52.1.15.

    PubMed 28387555
  • Zuckerman SL, Kerr ZY, Yengo-Kahn A, Wasserman E, Covassin T, Solomon GS. Epidemiology of Sports-Related Concussion in NCAA Athletes From 2009-2010 to 2013-2014: Incidence, Recurrence, and Mechanisms. Am J Sports Med. 2015 Nov;43(11):2654-62. doi: 10.1177/0363546515599634. Epub 2015 Sep 1.

    PubMed 26330572
  • Smith BE, Selfe J, Thacker D, Hendrick P, Bateman M, Moffatt F, Rathleff MS, Smith TO, Logan P. Incidence and prevalence of patellofemoral pain: A systematic review and meta-analysis. PLoS One. 2018 Jan 11;13(1):e0190892. doi: 10.1371/journal.pone.0190892. eCollection 2018.

    PubMed 29324820
  • Hunt KJ, Hurwit D, Robell K, Gatewood C, Botser IB, Matheson G. Incidence and Epidemiology of Foot and Ankle Injuries in Elite Collegiate Athletes. Am J Sports Med. 2017 Feb;45(2):426-433. doi: 10.1177/0363546516666815. Epub 2016 Nov 2.

    PubMed 27802962

Questions about this trial

What is this clinical trial studying?

An observational study of Chronic Pelvic Pain Syndrome, run by Loyola University at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 31 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Difference in two receiver operating characteristic curves (time frame: 0 Days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05750212, which also lists 102 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2026.

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