Serum hormone levels in women with chronic pain

Not Applicable

Completed

• Conditions: Chronic pelvic and chronic muscloskeletal pain; Musculoskeletal Diseases; Musculoskeletal pain

• Registration Number: ISRCTN31708861
• Lead Sponsor: niversity of Oxford (UK)

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-10
• Study Completion: 2019-07-31
• Last Update Posted: 10 January 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 101

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

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

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<br> Hormonal profiles of women with chronic pain:<br> 1. Oestradiol<br> 2. Progesterone<br> 3. Testosterone<br> 4. FSH<br> 5. Cortisol<br> 6. SHBG<br>

Secondary Outcome Measures

Name	Time	Method
<br> Relation between disease characteristics and suppression of HPO and HPA axes (hormone profiles and measures of pain severity and duration)<br><br> 1. Numeric rating scales (NRS) will be used to measure average daily pain and most severe pain.<br> 2. A body map will be used to visually identify the location of pain(s).<br> 3. Validated measures will be used to measure psychological state cognitive processes:<br> 3.1. STAI – Stait and trait anxiety questionnaires<br> 3.2. Beck depression inventory (BDI)<br> 3.3 Mcgill pain questionnaire, short form (SF-MPQ2)<br> 3.4 Pain Catastrophising scale (PCS) will also be used<br>