Plain English Summary
Background and study aims
Long-term pain is a major public health issue. In the UK, about 7•8 million people live with chronic pain and someone is in pain in more than a third of the households. The aim in this study is to further our understanding of the mechanism of pain in women with long-term pain and to inform the design of future clinical trials of sex steroid hormones for pain relief.
Who can participate?
Women who have had pain for at least 6 months, aged 18–50
What does the study involve?
Participants will attend one hospital visit to complete a questionnaire and give a blood sample for the measurement of hormone levels.
What are the possible benefits and risks of participating?
There are no benefits. The risks might be brief pain associated with the blood test and difficulty answering the questions on the study questionnaire because chronic pain is associated with psychological distress.
Where is the study run from?
Oxford University Hospital (UK)
When is the study starting and how long is it expected to run for?
March 2015 to December 2017
Who is funding the study?
Medical Research Fund (UK)
Who is the main contact?
Dr Katy Vincent, email@example.com
Dr Katy Vincent
Senior Fellow in Pain in Women and Honorary Consultant Gynaecologist
Nuffield Department of Women’s & Reproductive Health
University of Oxford
John Radcliffe Hospital
+44 (0)1865 220024
Serum hormone levels in women with chronic pain in the Women In Pain Studies, Oxford: a cohort study
To what extent is the hormone profile altered in women with chronic pain altered?:
1. Specifically, what proportion of women are hypoestrogenic, hypoandrogenic and hypocortisolaemic?
2. Do clinical symptoms relate to the extent of hypothalamic-pituitary-ovarian (HPO)/hypothalamo-pituitary-adrenal (HPA) axis suppression?
NRES Committee South Central - Oxford B, 26/01/2015, ref: 15/SC/0077
Single centre observational cohort study
Primary study design
Secondary study design
Patient information sheet
Not available in web format, please use contact details to request a patient information sheet.
Chronic pelvic and chronic muscloskeletal pain
Women will attend a single dedicated research appointment and will
1. Complete a questionnaire assessing the severity, nature and location of their pain; regularity of their menstrual cycle; levels of perceived stress; psychological well being; and a brief focused medical history.
2. Have height and weight measurements and calculation of their body-mass index
3. Have a blood sample taken for analysis of hormone levels: oestradiol, progesterone, testosterone, follicle-stimulating hormone (FSH), cortisol and sex-hormone binding globulin (SHBG)
4. Have vitamin D levels measured
Primary outcome measure
Hormonal profiles of women with chronic pain:
Secondary outcome measures
Relation between disease characteristics and suppression of HPO and HPA axes (hormone profiles and measures of pain severity and duration)
1. Numeric rating scales (NRS) will be used to measure average daily pain and most severe pain.
2. A body map will be used to visually identify the location of pain(s).
3. Validated measures will be used to measure psychological state cognitive processes:
3.1. STAI – Stait and trait anxiety questionnaires
3.2. Beck depression inventory (BDI)
3.3 Mcgill pain questionnaire, short form (SF-MPQ2)
3.4 Pain Catastrophising scale (PCS) will also be used
Overall trial start date
Overall trial end date
Reason abandoned (if study stopped)
Participant inclusion criteria
1. Willing and able to give informed consent
2. Age 18–50
3. Pelvic or musculoskeletal pain (back, hip or knee or fibromyalgia) for more than 50% of the days per month for at least the past 6 months
Target number of participants
Participant exclusion criteria
1. Use of exogenous hormones for any reason (including contraception, hormone-replacement therapy and treatment of pain), except women with pelvic pain who may be included if they have a Mirena intrauterine system in place
2. Use of mild opiates (e.g., codeine phosphate or tramadol) for 50% of the days per month
3. Use of strong opiates in the past 6 months
4. Previous hysterectomy or bilateral oophorectomy
5. Confirmed or suspected pregnancy
6. Pregnant within the past 6 months or currently breastfeeding
7. Recreational opiate use in the past 6 months
8. Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant’s ability to participate in the trial
Recruitment start date
Recruitment end date
Countries of recruitment
Trial participating centre
Oxford University Hospital
Nuffield Department of Obstetrics and Gynaecology Level 3 Women's Centre Headington
University of Oxford (UK)
Nuffield Department of Obstetrics and Gynaecology
+44 (0)186 522 1021
Medical Research Fund (UK)
Funding Body Type
Funding Body Subtype
Results and Publications
Publication and dissemination plan
Findings will be disseminated via peer-reviewed publications and presentation at relevant pain, gynaecology and endocrinology meetings. The plan is to submit the manuscript to an appropriate journal within 3 months of completion of the study.
IPD Sharing plan:
The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Katy Vincent, firstname.lastname@example.org.
Intention to publish date
Participant level data
Available on request
Basic results (scientific)