Dysmenorrhoea, Pelvic Pain, Chronic Pain
Conditions
Keywords
TLR2, TLR4, Biomarker, TLR responsiveness, Peripheral blood responsiveness, Inflammatory pain
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
Interventions
DRUGOCPs
Participants in the contraceptive pill groups can use any one of the following contraceptive pills: Oestradiol valerate and dienogest, drospirenone and ethinyl estradiol , ethinyloestradiol and levonorgestrel, cyproterone and ethinyl estradiol, ethinylestradiol and norethisterone, Nomegestrol Acetate and Oestradiol and Ethinyl Estra
Sponsors
University of Adelaide
Study design
Observational model
COHORT
Time perspective
CROSS_SECTIONAL
Eligibility
Sex/Gender
FEMALE
Age
16 Years to 35 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reactivity of stimulated isolated peripheral blood immune cells | 2 weeks | To determine if there are different inflammatory pain phenotypes between young women with either severe dysmenorrhoea alone, chronic pelvic pain from controls with mild or no dysmenorrhoea from the collected peripheral blood immune cells (assessed by cytokine output). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Levels of anxiety and depression using the DAS21 | 2 weeks | Secondary efficacy end point |
| Impact of pelvic pain on everyday activities using the Pelvic Pain Questionnaire | 2 weeks | Secondary efficacy end point |
Countries
Australia
Outcome results
None listed