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. Author manuscript; available in PMC: 2014 Sep 1.
Published in final edited form as: Contemp Clin Trials. 2013 Jun 29;36(1):154–165. doi: 10.1016/j.cct.2013.06.015

Table 1.

Goal, hypotheses and measurements.

Goal 1.
Determine the efficacy of G-ERa for treatment of PVDb compared to placebo 1a. Pain from tampon insertion will be lower in PVD patients when treated with G-ER compared to when treated with placebo (primary outcome variable. Diary
1b. Pain from intercourse will be lower in PVD patients when treated with G-ER compared to when treated with placebo. Diary
1c. 24-hour vulvar pain will be lower in PVD patients when treated with G-ER compared to when treated with placebo. Diary
Goal 2.
Identify psychophysiological measures of treatment response and define mechanistically-based PVD subtypes including central vs. peripheral sensitization, pelvic hypertonicity, tender point tenderness and autonomic dysregulation 2a. G-ER will reduce mechanical allodynia compared to placebo Von frey hair, brush, Algesiometer
2b. G-ER will reduce area and duration of hypersensitivity induced by intradermal capsaicin compared to placebo Capsaicin skin sensitivity test
2c. G-ER will reduce vaginal muscle pain to palpation compared to placebo Vaginal algometer
2d. G-ER will decrease the number and intensity of somatic tender points compared to placebo Tender point tenderness test
2e. G-ER will increase cardiac beat-to-beat variability compared to placebo Heart rate variability
a

G-ER: gabapentin extended release.

b

PVD: provoked vestibulodynia.