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, 

References & Publications (102)

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. — View Citation

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. — View Citation

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. — View Citation

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

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/ — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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

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

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

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. Erratum In: Am J Sports Med. 2016 Jan;44(1):NP5. — View Citation

* 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