Condition category
Musculoskeletal Diseases
Date applied
15/01/2015
Date assigned
10/04/2015
Last edited
12/04/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Ongoing
Recruitment status
Recruiting

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
katy.vincent@obs-gyn.ox.ac.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Katy Vincent

ORCID ID

Contact details

Nuffield Department of Obstetrics and Gynaecology
Level 3
Women's Centre
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)186 522 1021
katy.vincent@obs-gyn.ox.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Serum hormone levels in women with chronic pain in the Women In Pain Studies, Oxford: a cohort study

Acronym

WIPSOx1

Study hypothesis

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?

Ethics approval

NRES Committee South Central - Oxford B, 26/01/2015

Study design

Single centre observational cohort study

Primary study design

Observational

Secondary study design

Cohort study

Trial setting

Hospitals

Trial type

Screening

Patient information sheet

Not available in web format, please use contact details to request a patient information sheet.

Condition

Chronic pelvic and chronic muscloskeletal pain

Intervention

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

Intervention type

Other

Phase

Drug names

Primary outcome measures

Hormonal profiles of women with chronic pain:
1. Oestradiol
2. Progesterone
3. Testosterone
4. FSH
5. Cortisol
6. SHBG

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

01/03/2015

Overall trial end date

01/12/2017

Reason abandoned

Eligibility

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

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

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

01/01/2015

Recruitment end date

01/12/2017

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Oxford University Hospital
Nuffield Department of Obstetrics and Gynaecology Level 3 Women's Centre Headington
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

University of Oxford (UK)

Sponsor details

Nuffield Department of Obstetrics and Gynaecology
Level 3
Women's Centre
Headington
Oxford
OX3 9DU
United Kingdom
+44 (0)186 522 1021
Lisa.buck@obs-gyn.ox.ac.uk

Sponsor type

University/education

Website

Funders

Funder type

Research organisation

Funder name

Medical Research Fund (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Findings will be disseminated via peer-reviewed publications and presentation at relevant pain, gynaecology and endocrinology meetings. We plan to submit the manuscript to an appropriate journal within 3 months of completion of the study.

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes

On 12/04/2016 the following changes were made to the trial record: 1. The overall trial end date was changed from 01/03/2016 to 01/12/2017. 2. The recruitment end date was changed from 01/12/2015 to 01/12/2017.