Background and aim
Vulvodynia is a disabling cause of chronic gynecological pain, with poorly understood pathogenesis. A dysregulated pro-inflammatory and immune signaling by toll-like receptors (TRLs) may play a role in vulvar pain. Our project aims to use polietilen-anandamide(PEA) and curcumin as therapy tailored on the specific TLRs state.

Methods
In this stratified randomized controlled trial, we will reach statistical significance with a sample size of 92 patients with a clinical diagnosis and symptoms of vulvodynia. Recruited patients will undergo vulvar in-office examination and biopsy to assess TRLs expression and activity. According to the biopsy, data patients will be randomized defining four groups. Patients with high levels of TLRs treated using PEA (TAH-group) or PEA+Curcumin (TBH-group); patients with lower levels of TLRs treated using PEA (TAL-group) or PEA+Curcumin (TBL-group). We will evaluate by physical examination, questionnaires and tests the recruited patients to define pain characteristics, quality of life and sexual life, at T0 (recruiting phase), T1 (20 days post-treatment), T2 (60 days post-treatment) T3 (120 days post-treatment).

Results
The study will last for at least 24 months; preliminary results will be furnished. According to data published in previous literature and our clinical experience, we expect a decrease in pain entity of 50% in the TAL and TBL-groups, 70% TAH-group, and 80% in TBH-group. 

Conclusions
PEA or PEA+Curcumin based treatments may be alternatives to the currently available therapeutic approaches that are not satisfying, in term both of failed therapeutic response and high recurrence rate.

THE VITA-OK PROTOCOL FOR CHRONIC GYNECOLOGICAL PAIN: TOLL-LIKE RECEPTOR TARGETED TREATMENT IN VULVODYNIA