Management of endometriosis-related chronic pelvic pain (CPP). Urological and Genital Diseases
Conditions
Interventions
The study is a randomised, double-blind, sham-controlled trial evaluating the effectiveness of at-home transcranial direct current stimulation (tDCS) for chronic pelvic pain (CPP) in women with endome
Sponsors
Samphire Neuroscience Ltd
Eligibility
Sex/Gender
Female
Age
18 Years to 50 Years
Inclusion criteria
Inclusion criteria: 1. Women aged 18 to 50 years. 2. Confirmed diagnosis of endometriosis based on previous surgery, histology, MRI, or ultrasound findings. 3. Experiencing chronic pelvic pain (CPP) associated with endometriosis, defined as pain persisting for more than three months in the past six months with an intensity of at least 3 out of 10 on the Numerical Rating Scale (NRS). 4. Ability to complete symptom questionnaires and follow study procedures. 5. Capacity to provide informed consent for medical investigation and treatment. 6. Access to a compatible smartphone (Android or Apple) capable of hosting the study application.
Exclusion criteria
Exclusion criteria: 1. Severe or untreated neurological disease, such as subarachnoid haemorrhage or multiple sclerosis. 2. History of brain surgery, brain tumors, or intracranial metal implants. 3. History of stroke or head trauma. 4. History of epilepsy. 5. Active skin lesions, infections, open wounds, or cuts on the scalp. 6. Scalp conditions such as dermatitis, eczema, psoriasis, significant scarring, burns, or other forms of skin damage in areas where electrodes are placed. 7. Presence of brain implants. 8. Severe and/or untreated psychiatric illness, such as schizophrenia. 9. Metal implants or pacemakers, including implanted cardiac devices. 10. Pregnancy or plans to become pregnant within the next 12 months. 11. Currently breastfeeding. 12. Lack of capacity to consent.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain is measured using the Numerical Rating Scale (NRS) at baseline, daily during the 20-day intervention, post-intervention (Day 20), and one menstrual cycle post-intervention. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Pain catastrophising measured using the Pain Catastrophising Scale (PCS) at baseline, post-intervention (Day 20), and one menstrual cycle post-intervention. 2. Quality of life measured using the Endometriosis Health Profile-30 (EHP-30) at baseline, post-intervention (Day 20), and one menstrual cycle post-intervention. 3. Positive and negative affect measured using the Positive and Negative Affect Schedule (PANAS) at baseline, post-intervention (Day 20), and one menstrual cycle post-intervention. 4. State and trait anxiety measured using the State-Trait Anxiety Inventory (STAI) at baseline, post-intervention (Day 20), and one menstrual cycle post-intervention. 5. Depressive symptoms measured using the Beck Depression Inventory (BDI) at baseline, post-intervention (Day 20), and one menstrual cycle post-intervention. 6. Premenstrual symptom severity measured using the Daily Record of Severity of Problems (DRSP) continuously throughout the intervention and one menstrual cycle post-intervention. 7. Daily medication use recorded using the Daily Medication Diary daily during the intervention and one menstrual cycle post-intervention. Added 07/11/2025: 8. Health-related quality of life measured using the EuroQol 5-Dimension 5-Level (EQ-5D-5L) at baseline, post-intervention (Day 20), and one menstrual cycle post-intervention. | — |
Countries
England, United Kingdom
Contacts
Public ContactEmile Radyte
Outcome results
None listed