The Progression From Dysmenorrhoea to Chronic Pelvic Pain

Chronic Pain Clinical Trial

Official title: The Progression From Dysmenorrhoea to Chronic Pelvic Pain: Investigation of the Role of Chronic Inflammatory Pain Phenotype in Peripheral Blood as a Potential Biomarker.

Status Active, not recruiting

Clinical Trial Summary

This is a cross-sectional observational study.

For participants resident in Adelaide, South Australia.

The study consists of 3 visits to the Pain and Anaesthesia Research Clinic (PARC), within the Royal Adelaide Hospital (RAH).

A total of 56 participants will be recruited for this study.

Clinical Trial Description

The study will involve a screening visit followed by two visits to PARC for blood sampling and questionnaires.

At the baseline visit, blood samples to assess biomarkers and confirm hormonal status will be taken.

From screening until the final study visit a total of approximately 120 mL in blood samples will be taken from each participant.

The study aims to further knowledge in the presence of severe pelvic pain in young women which is an area that has been under-researched with regard to it's impact on society.

The study proposes to enroll 7 groups of 8 healthy nulliparous women aged 18-35 with the following characteristics:

Mild or absent dysmenorrhoea (pain scale 0-3) and no other pelvic pain symptoms. (3 groups)

• Group 1, without contraceptive pill use

• Group 2A , contraceptive pill user and with a history of mild or absent dysmenorrhoea prior to pill use

• Group 2B, contraceptive pill user and with a history of severe dysmenorrhoea (pain scale 7-10) prior to pill use

Severe dysmenorrhoea (pain scale 7-10), but without chronic pelvic pain. (2 groups)

• Group 3, without contraceptive pill use

• Group 4, contraceptive pill user

Chronic pelvic pain and severe dysmenorrhoea (2 groups)

• Group 5, without contraceptive pill use

• Group 6,contraceptive pill user ;

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Pain
• Dysmenorrhea
• Dysmenorrhoea
• Pelvic Pain

• NCT number: NCT02636972
• Study type: Observational
• Source: University of Adelaide
• Status: Active, not recruiting
• Phase: N/A
• Start date: November 2014
• Completion date: January 2016