The Progression From Dysmenorrhoea to Chronic Pelvic Pain: Investigation of the Role of Chronic Inflammatory Pain Phenotype in Peripheral Blood as a Potential Biomarker.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- Reactivity of stimulated isolated peripheral blood immune cells
研究概览
简要总结
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.
详细描述
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:
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 16 Years 至 35 Years（Child, Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Age between 16 to 35 years old
排除标准
- •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
研究组 & 干预措施
Group 2A
History of mild or absent dysmenorrhoea prior to pill use and no other pelvic pain symptoms with contraceptive pill use (Participants already using contraceptive pills).
干预措施: OCPs (Drug)
Group 2B
History of severe dysmenorrhoea prior to pill use and no other pelvic pain symptoms with contraceptive pill use (Participants already using contraceptive pills).
干预措施: OCPs (Drug)
Group 4
Severe dysmenorrhoea but without chronic pelvic pain and with contraceptive pill use (Participants already using contraceptive pills).
干预措施: OCPs (Drug)
Group 6
Chronic pelvic pain and severe dysmenorrhoea with contraceptive pill use (Participants already using contraceptive pills).
干预措施: OCPs (Drug)
结局指标
主要结局
Reactivity of stimulated isolated peripheral blood immune cells
时间窗: 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).
次要结局
- Levels of anxiety and depression using the DAS21(2 weeks)
- Impact of pelvic pain on everyday activities using the Pelvic Pain Questionnaire(2 weeks)
研究者
Dr Susan Evans
MBBS, FRANZCOG, FFPMANZCA, GAICD
University of Adelaide