Serum hormone levels in women with chronic pain
| ISRCTN | ISRCTN31708861 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN31708861 |
| Secondary identifying numbers | N/A |
- Submission date
- 15/01/2015
- Registration date
- 10/04/2015
- Last edited
- 29/12/2021
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Musculoskeletal Diseases
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@wrh.ox.ac.uk
Contact information
Scientific
Associate Professor, Senior Fellow in Pain in Women and Honorary Consultant Gynaecologist
Nuffield Department of Women’s & Reproductive Health
University of Oxford
John Radcliffe Hospital
Oxford
OX3 9DU
United Kingdom
| Phone | +44 (0)1865 220024 |
|---|---|
| katy.vincent@wrh.ox.ac.uk |
Study information
| Study design | Single centre observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Screening |
| Participant information sheet | Not available in web format, please use contact details to request a patient information sheet. |
| Scientific title | Serum hormone levels in women with chronic pain in the Women In Pain Studies, Oxford: a cohort study |
| 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(s) | NRES Committee South Central - Oxford B, 26/01/2015, ref: 15/SC/0077 |
| 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 |
| Primary outcome measure | 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 study start date | 01/03/2015 |
| Overall study end date | 31/07/2019 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Female |
| Target number of participants | 200 |
| Total final enrolment | 101 |
| 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 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 | 31/12/2016 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Level 3
Women's Centre
Headington
Oxford
OX3 9DU
United Kingdom
Sponsor information
University/education
Nuffield Department of Obstetrics and Gynaecology
Level 3, Women's Centre
Headington
Oxford
OX3 9DU
England
United Kingdom
| Phone | +44 (0)186 522 1021 |
|---|---|
| Lisa.buck@obs-gyn.ox.ac.uk | |
"ROR" |
https://ror.org/052gg0110 |
Funders
Funder type
Research organisation
No information available
Results and Publications
| Intention to publish date | 01/06/2022 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| 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, katy.vincent@wrh.ox.ac.uk. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 26/07/2023 | No | No |
Editorial Notes
29/12/2021: The intention to publish date has been changed from 01/11/2021 to 01/06/2022.
10/08/2021: The following changes were made to the trial record:
1. The intention to publish date was changed from 01/03/2018 to 01/11/2021.
2. Total final enrolment added.
03/08/2020: The scientific contact's details have been changed and the plain English summary and IPD sharing statement have been updated accordingly.
12/12/2018: The overall trial end date has been updated from 01/12/2017 to 31/07/2019.
14/03/2017: The recruitment end date has been updated from 01/12/2017 to 31/12/2016.
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.
