Endometriosis-related pain Urological and Genital Diseases Endometriosis, unspecified
Conditions
Interventions
Participants are randomised to receive either omega-3 purified fatty acids (fish oil) or olive oil soft gelatin (placebo) capsules, with a dose of 1000 mg each, and advised to take two capsules per da
Sponsors
University of Edinburgh and NHS Lothian
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Aged 18-50 years 2. Known endometriosis diagnosed from previous laparoscopy 3. Pain of at least 3 months duration located in the true pelvis 4. Worst pain score =4 over 4 weeks as measured by Numerical Rating Score (NRS) 5. Ability to provide informed consent
Exclusion criteria
Exclusion criteria: 1. Unable to take/allergic to fish/PUFA/peanuts/soyabean 2. Insulin dependent diabetes 3. Pregnant 4. Taking contraindicated medications (anticoagulants) 5. Breastfeeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The proportion of screened women who are eligible for the trial 2. The proportion of eligible patients randomised into the study 3. The proportion of randomised patients who take the supplement and complete questionnaires at final follow up The outcomes will be measured at baseline and at the end of the study (i.e., 8 weeks). | — |
Secondary
| Measure | Time frame |
|---|---|
| The remaining outcomes will be used to refine the research methodology of a future large RCT: 1. Pain, measured using the Numerical Rating Score (NRS) collected via text message during the screening phase (-1 to -4 weeks) and last 4 weeks (weeks 5-8) of the treatment phase 2. Eicosapentaenoic acid, arachidonic acid and docosahexaenoic acid concentrations measured from peripheral venous blood samples at baseline and 8 weeks 3. Quality of life, measured using SF-12 at baseline and 8 weeks 4. Pain, measured using the Brief Pain Inventory (BPI) at baseline and 8 weeks 5. Pain catastrophizing, measured using the Pain Catastrophising Questionnaire (PCQ) at baseline and 8 weeks 5. Pain, measures using the PainDETECT™ questionnaire at baseline and 8 weeks 6. Sexual activity, measured using the Sexual Activity Questionnaire (SAQ) at baseline and 8 weeks 7. Fatigue, measured using the Brief Fatigue Inventory (BFI) at baseline and 8 weeks 8. General health, measures using the General Health Questionnaire -12 (GHQ-12) at baseline and 8 weeks 9. Work and productivity activity impairment, measured using the Work and Productivity Activity Impairment Questionnaire- Specific Health Problem version 2.0 (WPAI-SHP) at baseline and 8 weeks 10. Acceptability of proposed methods of recruitment, randomisation, treatments and questionnaires, measured using a questionnaire at 8 weeks | — |
Countries
Scotland, United Kingdom
Contacts
Public ContactAnn Doust
Outcome results
None listed