Ignite Creation Date:
2024-05-05 @ 11:05 PM
Last Modification Date:
2024-10-26 @ 10:28 AM
Study NCT ID:
NCT01255345
Status:
UNKNOWN
Last Update Posted:
2011-06-27
First Post:
2010-12-06
Brief Title:
Female Chronic Pelvic Pain
Sponsor:
Copenhagen University Hospital at Herlev
Organization:
Copenhagen University Hospital at Herlev
Study Overview
Official Title:
Female Chronic Pelvic Pain Prevalence Risk Factors and Clinical Characteristics With Particular Reference to the Pelvic Musculature
Status:
UNKNOWN
Status Verified Date:
2010-10
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Female CPP
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 24 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 24 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 Fishers 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 Fishers 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
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 24 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 Fishers 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 Fishers 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None