Clinical trial NCT01255345: Female Chronic Pelvic Pain
Official title: Female Chronic Pelvic Pain: Prevalence, Risk Factors and Clinical Characteristics With Particular Reference to the Pelvic Musculature
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Pelvic Pain
Abdominal Pain
Painful Bladder Syndrome
Interstitial Cystitis
Irritable Bowel Syndrome
Keywords: Physiotherapy
Multidisciplinary Pain Centers
Pain measurements
Physical activity
Quality of life
Lead sponsor: Copenhagen University Hospital at Herlev
Sponsor class: OTHER
First posted: 2010-12-07
Enrollment: 2500
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: 2500 adult women living in Copenhagen Country and Zealand Country (total population 2,4 million), Denmark

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.

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

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Herlev
country: Denmark
facility: Department of Anaesthesiology, Herlev University Hospital
state: Copenhagen
Study officials:
References: