Clinical trial NCT02636972: The Progression From Dysmenorrhoea to Chronic Pelvic Pain
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.
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dysmenorrhoea
Pelvic Pain
Chronic Pain
Keywords: TLR2
TLR4
Biomarker
TLR responsiveness
Peripheral blood responsiveness
Inflammatory pain
Lead sponsor: University of Adelaide
Sponsor class: OTHER
First posted: 2015-12-22
Enrollment: 56
Sex: FEMALE
Minimum age (years): 16
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Nulliparous women in good general health (can experience dysmenorrhoea (abscent, mild or severe), with or without pelvic pain and with or without contraceptive pill use)

Brief 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.

Detailed 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

Eligibility criteria: Inclusion Criteria:

* Age between 16 to 35 years old

Exclusion Criteria:

* Irregular menstrual cycles
* Use of any reproductive hormonal preparations (other than the combined oral contraceptive pill), thyroxine, insulin or corticosteroids
* Presence of an inflammatory process, or clinically significant infection in the 4 weeks
* Clinically significant renal, hepatic, cardiac, auto-immune disease
* Current use of immunosuppressant medication such as hydroxychloroquine, methotrexate or azathioprine
* Inability to read or comprehend the written information provided
* Current use of medications known to affect TLR responsiveness including amitriptyline or minocycline
* Current use of any analgesics, including non-steroidal anti-inflammatory medications and opioids for 5 drug half-lives prior to the day of testing
* Current or previous pregnancy
* Body Mass index less than 18 or more than 30

Primary outcomes:
measure: Reactivity of stimulated isolated peripheral blood immune cells
timeFrame: 2 weeks
Secondary outcomes:
measure: Impact of pelvic pain on everyday activities using the Pelvic Pain Questionnaire
timeFrame: 2 weeks
measure: Levels of anxiety and depression using the DAS21
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Adelaide
country: Australia
facility: PARC, Royal Adelaide Hospital
state: South Australia
Study officials:
affiliation: PARC Research Clinic
name: Susan Evans, MBBS
role: PRINCIPAL_INVESTIGATOR
References: