Female Chronic Pelvic Pain

NCT ID: NCT01255345

Last Updated: 2011-06-27

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 2500 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-01-31
• Study Completion Date: 2012-12-31

Brief Summary

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.

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.

Conditions

Pelvic Pain; Abdominal Pain; Painful Bladder Syndrome; Interstitial Cystitis; Irritable Bowel Syndrome

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Adult females with CPP living in Denmark

Chronic pelvic pain

Intervention Type: OTHER

A physioterapeutic examination of abnormal muscular findings, i.e tonus, elasticitt and strength, in the pelvic area connected to female CPP.

Interventions

Chronic pelvic pain

A physioterapeutic examination of abnormal muscular findings, i.e tonus, elasticitt and strength, in the pelvic area connected to female CPP.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Copenhagen University Hospital at Herlev

OTHER

Sponsor Role: lead

Responsible Party

Multidisciplinary Pain Center, Herlev Hospital

Locations

Department of Anaesthesiology, Herlev University Hospital

Herlev, Copenhagen, Denmark

Site Status: RECRUITING

Countries

Denmark

Central Contacts

Sys Loving, PT, ph.d.

Role: CONTACT

sylo@heh.regionh.dk

0045 22128264

Facility Contacts

Sys Loving, PT, ph.d.-student

Role: primary

sylo@heh.regionh.dk

0045 22128264

Other Identifiers

H-1-2010-037

Identifier Type: -

Identifier Source: org_study_id