Female Chronic Pelvic Pain (Female CPP)
Recruitment status was Recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Pelvic Pain Abdominal Pain Painful Bladder Syndrome Interstitial Cystitis Irritable Bowel Syndrome |
Other: Chronic pelvic pain |
| Study Type: | Observational |
| Study Design: | Observational Model: Case Control Time Perspective: Cross-Sectional |
| Official Title: | Female Chronic Pelvic Pain: Prevalence, Risk Factors and Clinical Characteristics With Particular Reference to the Pelvic Musculature |
| Estimated Enrollment: | 2500 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | December 2012 |
| Groups/Cohorts | Assigned Interventions |
|---|---|
| Adult females with CPP living in Denmark |
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.
|
Detailed Description:
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Probability Sample |
2500 adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark
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
Contacts and Locations| Contact: Sys Loving, PT, ph.d. | 0045 22128264 | sylo@heh.regionh.dk |
| Denmark | |
| Department of Anaesthesiology, Herlev University Hospital | Recruiting |
| Herlev, Copenhagen, Denmark, 2730 | |
| Contact: Sys Loving, PT, ph.d.-student 0045 22128264 sylo@heh.regionh.dk | |
More Information
No publications provided
| Responsible Party: | Sys Loving, PT, MSc, ph.d.-student, Multidisciplinary Pain Center, Herlev Hospital |
| ClinicalTrials.gov Identifier: | NCT01255345 History of Changes |
| Other Study ID Numbers: | H-1-2010-037 |
| Study First Received: | December 6, 2010 |
| Last Updated: | June 23, 2011 |
| Health Authority: | Denmark: The Danish Data Protection Agency |
Keywords provided by Copenhagen University Hospital at Herlev:
|
Physiotherapy Multidisciplinary Pain Centers Pain measurements Physical activity Quality of life |
Additional relevant MeSH terms:
|
Abdominal Pain Pelvic Pain Pain Cystitis Irritable Bowel Syndrome Cystitis, Interstitial Signs and Symptoms Signs and Symptoms, Digestive |
Urinary Bladder Diseases Urologic Diseases Colonic Diseases, Functional Colonic Diseases Intestinal Diseases Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 22, 2013