Chronic pelvic and chronic muscloskeletal pain Musculoskeletal Diseases Musculoskeletal pain
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Hormonal profiles of women with chronic pain: 1. Oestradiol 2. Progesterone 3. Testosterone 4. FSH 5. Cortisol 6. SHBG | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 | — |
Countries
England, United Kingdom