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

NCT ID: NCT05750212

Last Updated: 2025-03-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

208 participants

Study Classification

OBSERVATIONAL

Study Start Date

2023-01-24

Study Completion Date

2025-10-24

Brief Summary

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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

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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.

Conditions

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Chronic Pelvic Pain Syndrome

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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Cases

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

Tone

Intervention Type DIAGNOSTIC_TEST

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

Tenderness

Intervention Type DIAGNOSTIC_TEST

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

Contraction

Intervention Type DIAGNOSTIC_TEST

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

Relaxation

Intervention Type DIAGNOSTIC_TEST

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

Electromyography

Intervention Type DIAGNOSTIC_TEST

Electromyography is a measurement of the pelvic floor muscle in microvolts

Transperineal

Intervention Type DIAGNOSTIC_TEST

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

Pressure

Intervention Type DIAGNOSTIC_TEST

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

Tone

Intervention Type DIAGNOSTIC_TEST

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

Tenderness

Intervention Type DIAGNOSTIC_TEST

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

Contraction

Intervention Type DIAGNOSTIC_TEST

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

Relaxation

Intervention Type DIAGNOSTIC_TEST

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

Electromyography

Intervention Type DIAGNOSTIC_TEST

Electromyography is a measurement of the pelvic floor muscle in microvolts

Transperineal

Intervention Type DIAGNOSTIC_TEST

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

Pressure

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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Tone

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

Intervention Type DIAGNOSTIC_TEST

Tenderness

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

Intervention Type DIAGNOSTIC_TEST

Contraction

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

Intervention Type DIAGNOSTIC_TEST

Relaxation

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

Intervention Type DIAGNOSTIC_TEST

Electromyography

Electromyography is a measurement of the pelvic floor muscle in microvolts

Intervention Type DIAGNOSTIC_TEST

Transperineal

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

Intervention Type DIAGNOSTIC_TEST

Pressure

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

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

21 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Loyola University

OTHER

Sponsor Role lead

Responsible Party

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Colleen M. Fitzgerald, MD, MS

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Colleen Fitzgerald, MD

Role: PRINCIPAL_INVESTIGATOR

Loyola Medical Center

Locations

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Loyola Medical Center

Maywood, Illinois, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Mary J Tulke, RN

Role: CONTACT

7082162067

Colleen Fitzgerald, MD

Role: CONTACT

7082163387

Facility Contacts

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Mary Tulke, RN

Role: primary

7082162067

References

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

Reference Type BACKGROUND
PMID: 24658485 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23234637 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31050659 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 32281205 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 30566976 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 31425373 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 17710181 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 21539165 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 15722283 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 10653551 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 8600737 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28387555 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26330572 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29324820 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27802962 (View on PubMed)

Russek LN, Errico DM. Prevalence, injury rate and, symptom frequency in generalized joint laxity and joint hypermobility syndrome in a "healthy" college population. Clin Rheumatol. 2016 Apr;35(4):1029-39. doi: 10.1007/s10067-015-2951-9. Epub 2015 May 1.

Reference Type BACKGROUND
PMID: 25930211 (View on PubMed)

Clauw DJ. Fibromyalgia: a clinical review. JAMA. 2014 Apr 16;311(15):1547-55. doi: 10.1001/jama.2014.3266.

Reference Type BACKGROUND
PMID: 24737367 (View on PubMed)

Prieto-Alhambra D, Judge A, Javaid MK, Cooper C, Diez-Perez A, Arden NK. Incidence and risk factors for clinically diagnosed knee, hip and hand osteoarthritis: influences of age, gender and osteoarthritis affecting other joints. Ann Rheum Dis. 2014 Sep;73(9):1659-64. doi: 10.1136/annrheumdis-2013-203355. Epub 2013 Jun 6.

Reference Type BACKGROUND
PMID: 23744977 (View on PubMed)

D'Ambrosia RD. Epidemiology of osteoarthritis. Orthopedics. 2005 Feb;28(2 Suppl):s201-5. doi: 10.3928/0147-7447-20050202-04.

Reference Type BACKGROUND
PMID: 15747607 (View on PubMed)

Compston JE, McClung MR, Leslie WD. Osteoporosis. Lancet. 2019 Jan 26;393(10169):364-376. doi: 10.1016/S0140-6736(18)32112-3.

Reference Type BACKGROUND
PMID: 30696576 (View on PubMed)

Dugan SA, Gabriel KP, Lange-Maia BS, Karvonen-Gutierrez C. Physical Activity and Physical Function: Moving and Aging. Obstet Gynecol Clin North Am. 2018 Dec;45(4):723-736. doi: 10.1016/j.ogc.2018.07.009. Epub 2018 Oct 25.

Reference Type BACKGROUND
PMID: 30401553 (View on PubMed)

Dugan SA, Powell LH, Kravitz HM, Everson Rose SA, Karavolos K, Luborsky J. Musculoskeletal pain and menopausal status. Clin J Pain. 2006 May;22(4):325-31. doi: 10.1097/01.ajp.0000208249.07949.d5.

Reference Type BACKGROUND
PMID: 16691084 (View on PubMed)

Lange-Maia BS, Karvonen-Gutierrez CA, Kazlauskaite R, Strotmeyer ES, Karavolos K, Appelhans BM, Janssen I, Avery EF, Dugan SA, Kravitz HM. Impact of Chronic Medical Condition Development on Longitudinal Physical Function from Mid- to Early Late-Life: The Study of Women's Health Across the Nation. J Gerontol A Biol Sci Med Sci. 2020 Jun 18;75(7):1411-1417. doi: 10.1093/gerona/glz243.

Reference Type BACKGROUND
PMID: 31732730 (View on PubMed)

Pettee Gabriel K, Sternfeld B, Colvin A, Stewart A, Strotmeyer ES, Cauley JA, Dugan S, Karvonen-Gutierrez C. Physical activity trajectories during midlife and subsequent risk of physical functioning decline in late mid-life: The Study of Women's Health Across the Nation (SWAN). Prev Med. 2017 Dec;105:287-294. doi: 10.1016/j.ypmed.2017.10.005. Epub 2017 Oct 5.

Reference Type BACKGROUND
PMID: 28987336 (View on PubMed)

Waetjen LE, Crawford SL, Chang PY, Reed BD, Hess R, Avis NE, Harlow SD, Greendale GA, Dugan SA, Gold EB; Study of Women's Health Across the Nation (SWAN). Factors associated with developing vaginal dryness symptoms in women transitioning through menopause: a longitudinal study. Menopause. 2018 Oct;25(10):1094-1104. doi: 10.1097/GME.0000000000001130.

Reference Type BACKGROUND
PMID: 29916947 (View on PubMed)

Rurangirwa AA, Gaillard R, Steegers EA, Hofman A, Jaddoe VW. Hemodynamic adaptations in different trimesters among nulliparous and multiparous pregnant women; the Generation R study. Am J Hypertens. 2012 Aug;25(8):892-9. doi: 10.1038/ajh.2012.57. Epub 2012 May 31.

Reference Type BACKGROUND
PMID: 22647784 (View on PubMed)

Hill CC, Pickinpaugh J. Physiologic changes in pregnancy. Surg Clin North Am. 2008 Apr;88(2):391-401, vii. doi: 10.1016/j.suc.2007.12.005.

Reference Type BACKGROUND
PMID: 18381119 (View on PubMed)

San-Frutos L, Engels V, Zapardiel I, Perez-Medina T, Almagro-Martinez J, Fernandez R, Bajo-Arenas JM. Hemodynamic changes during pregnancy and postpartum: a prospective study using thoracic electrical bioimpedance. J Matern Fetal Neonatal Med. 2011 Nov;24(11):1333-40. doi: 10.3109/14767058.2011.556203. Epub 2011 Feb 22.

Reference Type BACKGROUND
PMID: 21338331 (View on PubMed)

Elkus R, Popovich J Jr. Respiratory physiology in pregnancy. Clin Chest Med. 1992 Dec;13(4):555-65.

Reference Type BACKGROUND
PMID: 1478018 (View on PubMed)

Knuttgen HG, Emerson K Jr. Physiological response to pregnancy at rest and during exercise. J Appl Physiol. 1974 May;36(5):549-53. doi: 10.1152/jappl.1974.36.5.549. No abstract available.

Reference Type BACKGROUND
PMID: 4826317 (View on PubMed)

ACOG Committee Opinion No. 650: Physical Activity and Exercise During Pregnancy and the Postpartum Period. Obstet Gynecol. 2015 Dec;126(6):e135-e142. doi: 10.1097/AOG.0000000000001214.

Reference Type BACKGROUND
PMID: 26595585 (View on PubMed)

Heckman JD, Sassard R. Musculoskeletal considerations in pregnancy. J Bone Joint Surg Am. 1994 Nov;76(11):1720-30. doi: 10.2106/00004623-199411000-00018. No abstract available.

Reference Type BACKGROUND
PMID: 7962034 (View on PubMed)

FitzGerald MP, Payne CK, Lukacz ES, Yang CC, Peters KM, Chai TC, Nickel JC, Hanno PM, Kreder KJ, Burks DA, Mayer R, Kotarinos R, Fortman C, Allen TM, Fraser L, Mason-Cover M, Furey C, Odabachian L, Sanfield A, Chu J, Huestis K, Tata GE, Dugan N, Sheth H, Bewyer K, Anaeme A, Newton K, Featherstone W, Halle-Podell R, Cen L, Landis JR, Propert KJ, Foster HE Jr, Kusek JW, Nyberg LM; Interstitial Cystitis Collaborative Research Network. Randomized multicenter clinical trial of myofascial physical therapy in women with interstitial cystitis/painful bladder syndrome and pelvic floor tenderness. J Urol. 2012 Jun;187(6):2113-8. doi: 10.1016/j.juro.2012.01.123. Epub 2012 Apr 12.

Reference Type BACKGROUND
PMID: 22503015 (View on PubMed)

Halder GE, Scott L, Wyman A, Mora N, Miladinovic B, Bassaly R, Hoyte L. Botox combined with myofascial release physical therapy as a treatment for myofascial pelvic pain. Investig Clin Urol. 2017 Mar;58(2):134-139. doi: 10.4111/icu.2017.58.2.134. Epub 2017 Feb 1.

Reference Type BACKGROUND
PMID: 28261683 (View on PubMed)

Bartley J, Han E, Gupta P, Gaines N, Killinger KA, Boura JA, Farrah M, Gilleran J, Sirls LT, Peters KM. Transvaginal Trigger Point Injections Improve Pain Scores in Women with Pelvic Floor Hypertonicity and Pelvic Pain Conditions. Female Pelvic Med Reconstr Surg. 2019 Sep/Oct;25(5):392-396. doi: 10.1097/SPV.0000000000000581.

Reference Type BACKGROUND
PMID: 29621041 (View on PubMed)

Carey ET, Till SR, As-Sanie S. Pharmacological Management of Chronic Pelvic Pain in Women. Drugs. 2017 Mar;77(3):285-301. doi: 10.1007/s40265-016-0687-8.

Reference Type BACKGROUND
PMID: 28074359 (View on PubMed)

Andrews J, Yunker A, Reynolds WS, Likis FE, Sathe NA, Jerome RN. Noncyclic Chronic Pelvic Pain Therapies for Women: Comparative Effectiveness [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2012 Jan. Report No.: 11(12)-EHC088-EF. Available from http://www.ncbi.nlm.nih.gov/books/NBK84586/

Reference Type BACKGROUND
PMID: 22439157 (View on PubMed)

Carter JE. Surgical treatment for chronic pelvic pain. JSLS. 1998 Apr-Jun;2(2):129-39.

Reference Type BACKGROUND
PMID: 9876726 (View on PubMed)

AbdelHafeez MA, Reda A, Elnaggar A, El-Zeneiny H, Mokhles JM. Gabapentin for the management of chronic pelvic pain in women. Arch Gynecol Obstet. 2019 Nov;300(5):1271-1277. doi: 10.1007/s00404-019-05272-z. Epub 2019 Aug 21.

Reference Type BACKGROUND
PMID: 31435774 (View on PubMed)

Chronic Pelvic Pain: ACOG Practice Bulletin, Number 218. Obstet Gynecol. 2020 Mar;135(3):e98-e109. doi: 10.1097/AOG.0000000000003716.

Reference Type BACKGROUND
PMID: 32080051 (View on PubMed)

TAVERNER D, SMIDDY FG. An electromyographic study of the normal function of the external anal sphincter and pelvic diaphragm. Dis Colon Rectum. 1959 Mar-Apr;2(2):153-60. doi: 10.1007/BF02616708. No abstract available.

Reference Type BACKGROUND
PMID: 13652783 (View on PubMed)

Sapsford RR, Hodges PW, Richardson CA, Cooper DH, Markwell SJ, Jull GA. Co-activation of the abdominal and pelvic floor muscles during voluntary exercises. Neurourol Urodyn. 2001;20(1):31-42. doi: 10.1002/1520-6777(2001)20:13.0.co;2-p.

Reference Type BACKGROUND
PMID: 11135380 (View on PubMed)

Sapsford RR, Richardson CA, Maher CF, Hodges PW. Pelvic floor muscle activity in different sitting postures in continent and incontinent women. Arch Phys Med Rehabil. 2008 Sep;89(9):1741-7. doi: 10.1016/j.apmr.2008.01.029.

Reference Type BACKGROUND
PMID: 18760158 (View on PubMed)

Weiss JM. Pelvic floor myofascial trigger points: manual therapy for interstitial cystitis and the urgency-frequency syndrome. J Urol. 2001 Dec;166(6):2226-31. doi: 10.1016/s0022-5347(05)65539-5.

Reference Type BACKGROUND
PMID: 11696740 (View on PubMed)

Bassaly R, Tidwell N, Bertolino S, Hoyte L, Downes K, Hart S. Myofascial pain and pelvic floor dysfunction in patients with interstitial cystitis. Int Urogynecol J. 2011 Apr;22(4):413-8. doi: 10.1007/s00192-010-1301-3. Epub 2010 Oct 26.

Reference Type BACKGROUND
PMID: 20976441 (View on PubMed)

Tu FF, As-Sanie S, Steege JF. Musculoskeletal causes of chronic pelvic pain: a systematic review of existing therapies: part II. Obstet Gynecol Surv. 2005 Jul;60(7):474-83. doi: 10.1097/01.ogx.0000162246.06900.9f.

Reference Type BACKGROUND
PMID: 15995564 (View on PubMed)

Tu FF, As-Sanie S, Steege JF. Prevalence of pelvic musculoskeletal disorders in a female chronic pelvic pain clinic. J Reprod Med. 2006 Mar;51(3):185-9.

Reference Type BACKGROUND
PMID: 16674013 (View on PubMed)

Peters KM, Carrico DJ, Diokno AC. Characterization of a clinical cohort of 87 women with interstitial cystitis/painful bladder syndrome. Urology. 2008 Apr;71(4):634-40. doi: 10.1016/j.urology.2007.11.013.

Reference Type BACKGROUND
PMID: 18387392 (View on PubMed)

Tu FF, Holt J, Gonzales J, Fitzgerald CM. Physical therapy evaluation of patients with chronic pelvic pain: a controlled study. Am J Obstet Gynecol. 2008 Mar;198(3):272.e1-7. doi: 10.1016/j.ajog.2007.09.002.

Reference Type BACKGROUND
PMID: 18313447 (View on PubMed)

Butrick CW. Pelvic floor hypertonic disorders: identification and management. Obstet Gynecol Clin North Am. 2009 Sep;36(3):707-22. doi: 10.1016/j.ogc.2009.08.011.

Reference Type BACKGROUND
PMID: 19932423 (View on PubMed)

Fitzgerald CM, Neville CE, Mallinson T, Badillo SA, Hynes CK, Tu FF. Pelvic floor muscle examination in female chronic pelvic pain. J Reprod Med. 2011 Mar-Apr;56(3-4):117-22.

Reference Type BACKGROUND
PMID: 21542528 (View on PubMed)

Meister MR, Sutcliffe S, Ghetti C, Chu CM, Spitznagle T, Warren DK, Lowder JL. Development of a standardized, reproducible screening examination for assessment of pelvic floor myofascial pain. Am J Obstet Gynecol. 2019 Mar;220(3):255.e1-255.e9. doi: 10.1016/j.ajog.2018.11.1106. Epub 2018 Dec 7.

Reference Type BACKGROUND
PMID: 30527941 (View on PubMed)

Frawley H, Shelly B, Morin M, Bernard S, Bo K, Digesu GA, Dickinson T, Goonewardene S, McClurg D, Rahnama'i MS, Schizas A, Slieker-Ten Hove M, Takahashi S, Voelkl Guevara J. An International Continence Society (ICS) report on the terminology for pelvic floor muscle assessment. Neurourol Urodyn. 2021 Jun;40(5):1217-1260. doi: 10.1002/nau.24658. Epub 2021 Apr 12.

Reference Type BACKGROUND
PMID: 33844342 (View on PubMed)

Beales DJ, O'Sullivan PB, Briffa NK. Motor control patterns during an active straight leg raise in chronic pelvic girdle pain subjects. Spine (Phila Pa 1976). 2009 Apr 20;34(9):861-70. doi: 10.1097/BRS.0b013e318198d212.

Reference Type BACKGROUND
PMID: 19531994 (View on PubMed)

Glazer HI, Jantos M, Hartmann EH, Swencionis C. Electromyographic comparisons of the pelvic floor in women with dysesthetic vulvodynia and asymptomatic women. J Reprod Med. 1998 Nov;43(11):959-62.

Reference Type BACKGROUND
PMID: 9839264 (View on PubMed)

Grape HH, Dedering A, Jonasson AF. Retest reliability of surface electromyography on the pelvic floor muscles. Neurourol Urodyn. 2009;28(5):395-9. doi: 10.1002/nau.20648.

Reference Type BACKGROUND
PMID: 19214991 (View on PubMed)

Dias N, Zhang C, Spitznagle T, Lai HH, Zhang Y. High-Density Surface Electromyography Assessment of Pelvic Floor Dysfunction in Women with Interstitial Cystitis/Bladder Pain Syndrome. J Urol. 2020 Dec;204(6):1275-1283. doi: 10.1097/JU.0000000000001237. Epub 2020 Jul 6.

Reference Type BACKGROUND
PMID: 32628100 (View on PubMed)

Peschers UM, Gingelmaier A, Jundt K, Leib B, Dimpfl T. Evaluation of pelvic floor muscle strength using four different techniques. Int Urogynecol J Pelvic Floor Dysfunct. 2001;12(1):27-30. doi: 10.1007/s001920170090.

Reference Type BACKGROUND
PMID: 11294527 (View on PubMed)

Stuge B, Saetre K, Braekken IH. The association between pelvic floor muscle function and pelvic girdle pain--a matched case control 3D ultrasound study. Man Ther. 2012 Apr;17(2):150-6. doi: 10.1016/j.math.2011.12.004. Epub 2012 Jan 15.

Reference Type BACKGROUND
PMID: 22245422 (View on PubMed)

Polpeta NC, Giraldo PC, Juliato CR, Yoshida LP, do Amaral RL, Eleuterio J Jr. Electromyography and vaginal pressure of the pelvic floor muscles in women with recurrent vulvovaginal candidiasis and vulvodynia. J Reprod Med. 2012 Mar-Apr;57(3-4):141-7.

Reference Type BACKGROUND
PMID: 22523874 (View on PubMed)

Voorham-van der Zalm PJ, Voorham JC, van den Bos TW, Ouwerkerk TJ, Putter H, Wasser MN, Webb A, DeRuiter MC, Pelger RC. Reliability and differentiation of pelvic floor muscle electromyography measurements in healthy volunteers using a new device: the Multiple Array Probe Leiden (MAPLe). Neurourol Urodyn. 2013 Apr;32(4):341-8. doi: 10.1002/nau.22311. Epub 2012 Sep 12.

Reference Type BACKGROUND
PMID: 22972554 (View on PubMed)

Voorham JC, De Wachter S, Van den Bos TWL, Putter H, Lycklama A Nijeholt GA, Voorham-van der Zalm PJ. The effect of EMG biofeedback assisted pelvic floor muscle therapy on symptoms of the overactive bladder syndrome in women: A randomized controlled trial. Neurourol Urodyn. 2017 Sep;36(7):1796-1803. doi: 10.1002/nau.23180. Epub 2016 Nov 21.

Reference Type BACKGROUND
PMID: 27869312 (View on PubMed)

Huskisson EC. Measurement of pain. J Rheumatol. 1982 Sep-Oct;9(5):768-9. No abstract available.

Reference Type BACKGROUND
PMID: 6184474 (View on PubMed)

Lapin B, Davin S, Stilphen M, Benzel E, Katzan IL. Validation of PROMIS CATs and PROMIS Global Health in an Interdisciplinary Pain Program for Patients With Chronic Low Back Pain. Spine (Phila Pa 1976). 2020 Feb 15;45(4):E227-E235. doi: 10.1097/BRS.0000000000003232.

Reference Type BACKGROUND
PMID: 31513107 (View on PubMed)

van den Hoven LH, Gorter KJ, Picavet HS. Measuring musculoskeletal pain by questionnaires: the manikin versus written questions. Eur J Pain. 2010 Mar;14(3):335-8. doi: 10.1016/j.ejpain.2009.06.002. Epub 2009 Aug 20.

Reference Type BACKGROUND
PMID: 19699125 (View on PubMed)

Pollard CA. Preliminary validity study of the pain disability index. Percept Mot Skills. 1984 Dec;59(3):974. doi: 10.2466/pms.1984.59.3.974. No abstract available.

Reference Type BACKGROUND
PMID: 6240632 (View on PubMed)

Tait RC, Pollard CA, Margolis RB, Duckro PN, Krause SJ. The Pain Disability Index: psychometric and validity data. Arch Phys Med Rehabil. 1987 Jul;68(7):438-41.

Reference Type BACKGROUND
PMID: 3606368 (View on PubMed)

Hill JC, Kang S, Benedetto E, Myers H, Blackburn S, Smith S, Dunn KM, Hay E, Rees J, Beard D, Glyn-Jones S, Barker K, Ellis B, Fitzpatrick R, Price A. Development and initial cohort validation of the Arthritis Research UK Musculoskeletal Health Questionnaire (MSK-HQ) for use across musculoskeletal care pathways. BMJ Open. 2016 Aug 5;6(8):e012331. doi: 10.1136/bmjopen-2016-012331.

Reference Type BACKGROUND
PMID: 27496243 (View on PubMed)

Rosen RC. Measurement of male and female sexual dysfunction. Curr Psychiatry Rep. 2001 Jun;3(3):182-7. doi: 10.1007/s11920-001-0050-x.

Reference Type BACKGROUND
PMID: 11353580 (View on PubMed)

O'Leary MP, Sant GR, Fowler FJ Jr, Whitmore KE, Spolarich-Kroll J. The interstitial cystitis symptom index and problem index. Urology. 1997 May;49(5A Suppl):58-63. doi: 10.1016/s0090-4295(99)80333-1.

Reference Type BACKGROUND
PMID: 9146003 (View on PubMed)

Francis CY, Morris J, Whorwell PJ. The irritable bowel severity scoring system: a simple method of monitoring irritable bowel syndrome and its progress. Aliment Pharmacol Ther. 1997 Apr;11(2):395-402. doi: 10.1046/j.1365-2036.1997.142318000.x.

Reference Type BACKGROUND
PMID: 9146781 (View on PubMed)

Jones G, Jenkinson C, Kennedy S. Development of the Short Form Endometriosis Health Profile Questionnaire: the EHP-5. Qual Life Res. 2004 Apr;13(3):695-704. doi: 10.1023/B:QURE.0000021321.48041.0e.

Reference Type BACKGROUND
PMID: 15130031 (View on PubMed)

Sullivan MJ, D'Eon JL. Relation between catastrophizing and depression in chronic pain patients. J Abnorm Psychol. 1990 Aug;99(3):260-3. doi: 10.1037//0021-843x.99.3.260.

Reference Type BACKGROUND
PMID: 2145334 (View on PubMed)

Craig CL, Marshall AL, Sjostrom M, Bauman AE, Booth ML, Ainsworth BE, Pratt M, Ekelund U, Yngve A, Sallis JF, Oja P. International physical activity questionnaire: 12-country reliability and validity. Med Sci Sports Exerc. 2003 Aug;35(8):1381-95. doi: 10.1249/01.MSS.0000078924.61453.FB.

Reference Type BACKGROUND
PMID: 12900694 (View on PubMed)

Lin I, Wiles L, Waller R, Goucke R, Nagree Y, Gibberd M, Straker L, Maher CG, O'Sullivan PPB. What does best practice care for musculoskeletal pain look like? Eleven consistent recommendations from high-quality clinical practice guidelines: systematic review. Br J Sports Med. 2020 Jan;54(2):79-86. doi: 10.1136/bjsports-2018-099878. Epub 2019 Mar 2.

Reference Type BACKGROUND
PMID: 30826805 (View on PubMed)

Majlesi J, Togay H, Unalan H, Toprak S. The sensitivity and specificity of the Slump and the Straight Leg Raising tests in patients with lumbar disc herniation. J Clin Rheumatol. 2008 Apr;14(2):87-91. doi: 10.1097/RHU.0b013e31816b2f99.

Reference Type BACKGROUND
PMID: 18391677 (View on PubMed)

Maitland GD. The slump test: examination and treatment. Aust J Physiother. 1985;31(6):215-9. doi: 10.1016/S0004-9514(14)60634-6.

Reference Type BACKGROUND
PMID: 25026106 (View on PubMed)

Vleeming A, Albert HB, Ostgaard HC, Sturesson B, Stuge B. European guidelines for the diagnosis and treatment of pelvic girdle pain. Eur Spine J. 2008 Jun;17(6):794-819. doi: 10.1007/s00586-008-0602-4. Epub 2008 Feb 8.

Reference Type BACKGROUND
PMID: 18259783 (View on PubMed)

Mens JM, Vleeming A, Snijders CJ, Koes BW, Stam HJ. Reliability and validity of the active straight leg raise test in posterior pelvic pain since pregnancy. Spine (Phila Pa 1976). 2001 May 15;26(10):1167-71. doi: 10.1097/00007632-200105150-00015.

Reference Type BACKGROUND
PMID: 11413432 (View on PubMed)

Mens JM, Vleeming A, Snijders CJ, Stam HJ, Ginai AZ. The active straight leg raising test and mobility of the pelvic joints. Eur Spine J. 1999;8(6):468-73. doi: 10.1007/s005860050206.

Reference Type BACKGROUND
PMID: 10664304 (View on PubMed)

Friedrich J, Brakke R, Akuthota V, Sullivan W. Reliability and Practicality of the Core Score: Four Dynamic Core Stability Tests Performed in a Physician Office Setting. Clin J Sport Med. 2017 Jul;27(4):409-414. doi: 10.1097/JSM.0000000000000366.

Reference Type BACKGROUND
PMID: 28653966 (View on PubMed)

Kockum B, Heijne AI. Hop performance and leg muscle power in athletes: Reliability of a test battery. Phys Ther Sport. 2015 Aug;16(3):222-7. doi: 10.1016/j.ptsp.2014.09.002. Epub 2014 Sep 19.

Reference Type BACKGROUND
PMID: 25891995 (View on PubMed)

Podsiadlo D, Richardson S. The timed "Up & Go": a test of basic functional mobility for frail elderly persons. J Am Geriatr Soc. 1991 Feb;39(2):142-8. doi: 10.1111/j.1532-5415.1991.tb01616.x.

Reference Type BACKGROUND
PMID: 1991946 (View on PubMed)

Dietz HP. Ultrasound imaging of the pelvic floor. Part I: two-dimensional aspects. Ultrasound Obstet Gynecol. 2004 Jan;23(1):80-92. doi: 10.1002/uog.939.

Reference Type BACKGROUND
PMID: 14971006 (View on PubMed)

Baguley SD, Curnow JS, Morrison GD, Barron LF. Vaginal algometer: development and application of a device to monitor vaginal wall pressure pain threshold. Physiol Meas. 2003 Nov;24(4):833-6. doi: 10.1088/0967-3334/24/4/302.

Reference Type BACKGROUND
PMID: 14658776 (View on PubMed)

Tu FF, Fitzgerald CM, Kuiken T, Farrell T, Norman Harden R. Vaginal pressure-pain thresholds: initial validation and reliability assessment in healthy women. Clin J Pain. 2008 Jan;24(1):45-50. doi: 10.1097/AJP.0b013e318156db13.

Reference Type BACKGROUND
PMID: 18180636 (View on PubMed)

Tu FF, As-Sanie S, Steege JF. Musculoskeletal causes of chronic pelvic pain: a systematic review of diagnosis: part I. Obstet Gynecol Surv. 2005 Jun;60(6):379-85. doi: 10.1097/01.ogx.0000167831.83619.9f.

Reference Type BACKGROUND
PMID: 15920438 (View on PubMed)

Nelson P, Apte G, Justiz R 3rd, Brismee JM, Dedrick G, Sizer PS Jr. Chronic female pelvic pain--part 2: differential diagnosis and management. Pain Pract. 2012 Feb;12(2):111-41. doi: 10.1111/j.1533-2500.2011.00492.x. Epub 2011 Jul 31.

Reference Type BACKGROUND
PMID: 21801301 (View on PubMed)

Gyang A, Hartman M, Lamvu G. Musculoskeletal causes of chronic pelvic pain: what a gynecologist should know. Obstet Gynecol. 2013 Mar;121(3):645-650. doi: 10.1097/AOG.0b013e318283ffea.

Reference Type BACKGROUND
PMID: 23635629 (View on PubMed)

Troiano RP, Berrigan D, Dodd KW, Masse LC, Tilert T, McDowell M. Physical activity in the United States measured by accelerometer. Med Sci Sports Exerc. 2008 Jan;40(1):181-8. doi: 10.1249/mss.0b013e31815a51b3.

Reference Type BACKGROUND
PMID: 18091006 (View on PubMed)

Bo K, Nygaard IE. Is Physical Activity Good or Bad for the Female Pelvic Floor? A Narrative Review. Sports Med. 2020 Mar;50(3):471-484. doi: 10.1007/s40279-019-01243-1.

Reference Type BACKGROUND
PMID: 31820378 (View on PubMed)

Dehnavi ZM, Jafarnejad F, Kamali Z. The Effect of aerobic exercise on primary dysmenorrhea: A clinical trial study. J Educ Health Promot. 2018 Jan 10;7:3. doi: 10.4103/jehp.jehp_79_17. eCollection 2018.

Reference Type BACKGROUND
PMID: 29417063 (View on PubMed)

Steege JF, Blumenthal JA. The effects of aerobic exercise on premenstrual symptoms in middle-aged women: a preliminary study. J Psychosom Res. 1993;37(2):127-33. doi: 10.1016/0022-3999(93)90079-u.

Reference Type BACKGROUND
PMID: 8463989 (View on PubMed)

Awad E, Ahmed HAH, Yousef A, Abbas R. Efficacy of exercise on pelvic pain and posture associated with endometriosis: within subject design. J Phys Ther Sci. 2017 Dec;29(12):2112-2115. doi: 10.1589/jpts.29.2112. Epub 2017 Dec 7.

Reference Type BACKGROUND
PMID: 29643586 (View on PubMed)

DeLong ER, DeLong DM, Clarke-Pearson DL. Comparing the areas under two or more correlated receiver operating characteristic curves: a nonparametric approach. Biometrics. 1988 Sep;44(3):837-45.

Reference Type BACKGROUND
PMID: 3203132 (View on PubMed)

Rosen R, Brown C, Heiman J, Leiblum S, Meston C, Shabsigh R, Ferguson D, D'Agostino R Jr. The Female Sexual Function Index (FSFI): a multidimensional self-report instrument for the assessment of female sexual function. J Sex Marital Ther. 2000 Apr-Jun;26(2):191-208. doi: 10.1080/009262300278597.

Reference Type BACKGROUND
PMID: 10782451 (View on PubMed)

Dyck PJ, Boes CJ, Mulder D, Millikan C, Windebank AJ, Dyck PJ, Espinosa R. History of standard scoring, notation, and summation of neuromuscular signs. A current survey and recommendation. J Peripher Nerv Syst. 2005 Jun;10(2):158-73. doi: 10.1111/j.1085-9489.2005.0010206.x.

Reference Type BACKGROUND
PMID: 15958127 (View on PubMed)

Kirshblum SC, Burns SP, Biering-Sorensen F, Donovan W, Graves DE, Jha A, Johansen M, Jones L, Krassioukov A, Mulcahey MJ, Schmidt-Read M, Waring W. International standards for neurological classification of spinal cord injury (revised 2011). J Spinal Cord Med. 2011 Nov;34(6):535-46. doi: 10.1179/204577211X13207446293695. No abstract available.

Reference Type BACKGROUND
PMID: 22330108 (View on PubMed)

Hallett M. NINDS myotatic reflex scale. Neurology. 1993 Dec;43(12):2723. doi: 10.1212/wnl.43.12.2723. No abstract available.

Reference Type BACKGROUND
PMID: 7802740 (View on PubMed)

Slieker-ten Hove MC, Pool-Goudzwaard AL, Eijkemans MJ, Steegers-Theunissen RP, Burger CW, Vierhout ME. Face validity and reliability of the first digital assessment scheme of pelvic floor muscle function conform the new standardized terminology of the International Continence Society. Neurourol Urodyn. 2009;28(4):295-300. doi: 10.1002/nau.20659.

Reference Type BACKGROUND
PMID: 19090583 (View on PubMed)

Apte G, Nelson P, Brismee JM, Dedrick G, Justiz R 3rd, Sizer PS Jr. Chronic female pelvic pain--part 1: clinical pathoanatomy and examination of the pelvic region. Pain Pract. 2012 Feb;12(2):88-110. doi: 10.1111/j.1533-2500.2011.00465.x. Epub 2011 May 26.

Reference Type BACKGROUND
PMID: 21615678 (View on PubMed)

Papoutsis D, Antonakou A. The Q-tip test of the vulva as a diagnostic aid for vulvodynia: sensitivity, specificity and predictive values. J Psychosom Obstet Gynaecol. 2019 Jun;40(2):90. doi: 10.1080/0167482X.2017.1415882. Epub 2017 Dec 19. No abstract available.

Reference Type BACKGROUND
PMID: 29256294 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

213778

Identifier Type: -

Identifier Source: org_study_id

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