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Female Chronic Pelvic Pain (Female CPP)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified October 2010 by Copenhagen University Hospital at Herlev.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01255345
First Posted: December 7, 2010
Last Update Posted: June 27, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Copenhagen University Hospital at Herlev
December 6, 2010
December 7, 2010
June 27, 2011
January 2011
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Complete list of historical versions of study NCT01255345 on ClinicalTrials.gov Archive Site
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Female Chronic Pelvic Pain
Female Chronic Pelvic Pain: Prevalence, Risk Factors and Clinical Characteristics With Particular Reference to the Pelvic Musculature
The purpose of this study is to investigate the frequency and severity of chronic pelvic pain (CPP) in adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark, in relation to selected factors, such as basic demographic and clinical factors, health related quality of life, physical activity and abnormal muscular findings in the pelvic area.

Introduction:

The aim of this study is to investigate the frequency and severity of chronic pelvic pain (CPP) in adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark, in relation to selected factors, such as basic demographic and clinical factors, health related quality of life, physical activity and abnormal muscular findings in the pelvic area.

Methods:

The study is designed as a cross-sectional, questionnaire-based survey and two randomly selected age stratified groups of the responding participating women, one with or one without pain, will receive a clinical examination by a specialist physiotherapist for abnormal muscular finding in the pelvic, lower abdominal or inguinal area.

Results:

Descriptive characteristics will be obtained by univariate analysis and presented as means with standard deviations, or percentages. T test and the Mann-Whitney test will be used to analyze continuous data with and without normal distribution, respectively, and the Chi-square test or Fisher's exact test will be used to analyze categorical data, as appropriate. Correlation between self-reported CPP and abnormal muscular findings will be analysed. Logistic regression analysis will be used to identify the independent variables significantly associated with CPP. For logistic regression analysis, we will select only those findings that are significant as determined by Fisher's exact or the Chi-square test, with values of 0 and 1 assigned to the absence and presence, respectively, of each variable in each subject.

Observational
Observational Model: Case Control
Time Perspective: Cross-Sectional
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Probability Sample
2500 adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark
  • Pelvic Pain
  • Abdominal Pain
  • Painful Bladder Syndrome
  • Interstitial Cystitis
  • Irritable Bowel Syndrome
Other: Chronic pelvic pain
A physioterapeutic examination of abnormal muscular findings, i.e tonus, elasticitt and strength, in the pelvic area connected to female CPP.
Adult females with CPP living in Denmark
Intervention: Other: Chronic pelvic pain
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Unknown status
2500
December 2012
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Inclusion Criteria:

  • Women ≥ 18 years
  • Living in Copenhagen Country (Region H)
  • Capable of reading, writing and speaking Danish

Exclusion Criteria:

  • Pain limited solely to the perineal skin or introitus (vulvodynia)
  • Pregnancy, cancer, active pelvic inflammatory disease
  • Operation in the pelvic during the last 6 months
  • Cognitively impaired individuals
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
Yes
Contact information is only displayed when the study is recruiting subjects
Denmark
 
 
NCT01255345
H-1-2010-037
Yes
Not Provided
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Sys Loving, PT, MSc, ph.d.-student, Multidisciplinary Pain Center, Herlev Hospital
Copenhagen University Hospital at Herlev
Not Provided
Not Provided
Copenhagen University Hospital at Herlev
October 2010
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