At-home transcranial direct current stimulation on endometriosis-related chronic pelvic pain: randomised, double-blind, sham-controlled trial
Management of endometriosis-related chronic pelvic pain (CPP).
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 endometriosis. Participants will be randomised into two arms: 1. Active tDCS Group – Participants will receive daily 20-minute sessions of active tDCS using the Nettle device for 20 consecutive days. The device targets the primary motor cortex (M1) and dorsolateral prefrontal cortex (DLPFC) to modulate pain perception and mood symptoms. 2. Sham Control Group – Participants will use the same device for 20 minutes daily for 20 days, but without active stimulation, ensuring blinding. Randomisation was carried out using the Excel randomisation formula, by a senior member of the team.
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.
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.