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.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02636972
• Other study ID #: PPAI-001
• Status: Active, not recruiting
• Phase: N/A
• First received: December 6, 2015
• Last updated: December 21, 2015
• Start date: November 2014
• Est. completion date: January 2016

Study information

• Verified date: December 2015
• Source: University of Adelaide
• Contact: n/a
• Is FDA regulated: No
• Health authority: Australia: Human Research Ethics Committee
• Study type: Observational

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.

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

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 56
• Est. completion date: January 2016
• Est. primary completion date: January 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 16 Years to 35 Years

Eligibility

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

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Chronic Pain
• Dysmenorrhea
• Dysmenorrhoea
• Pelvic Pain

Intervention

Drug:
• OCPs
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

Locations

Country	Name	City	State
Australia	PARC, Royal Adelaide Hospital	Adelaide	South Australia

Sponsors (1)

Lead Sponsor	Collaborator
University of Adelaide

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Reactivity of stimulated isolated peripheral blood immune cells	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).	2 weeks	Yes
Secondary	Impact of pelvic pain on everyday activities using the Pelvic Pain Questionnaire	Secondary efficacy end point	2 weeks	No
Secondary	Levels of anxiety and depression using the DAS21	Secondary efficacy end point	2 weeks	No