Physical Therapy as Adjuvant Treatment of Vulvodynia: a Randomized Controled Trial
Status:
Unknown status
Trial end date:
2017-12-01
Target enrollment:
Participant gender:
Summary
INTRODUCTION: Vulvodynia (chronic vulvar pain in the absence of clinical findings) has a
negative impact over quality of life in women with this diagnose. The existing treatments,
however, are manifold but insufficient. This study aims to verify the effectiveness of
kinesiotherapy and electrotherapy as adjuvant methods in the treatment of vulvodynia.
METHODS: A single-blind randomized controlled trial will examine 58 women, divided into three
treatment arms: use of tricyclic antidepressant alone (hydrochloride Amitriptyline),
amitriptyline hydrochloride associated with pelvic floor muscle exercises and amitriptyline
hydrochloride associated with electrotherapy (interferential current). Exclusion criteria
are: presence of infections or genital cancers, chronic degenerative diseases; younger than
18 years, neurological disease that jeopardizes the contraction of the muscles of the pelvic
floor, taking antidepressant drugs that have interaction with amitriptyline hydrochloride and
being pacemakers use. The parameters analyzed before and after treatment will be: muscle
volume of the anus elevator and perfusion of the pudendal artery obtained with 3D ultrasound,
subjective pain in vaginal intercourse (visual analog scale), monthly frequency of vaginal
intercourse, pain referred within vulvar touch on physical examination (swab test from zero
to 10) and female sexual function (Female Sexual Function questionnaire - FSFI). There will
be a follow up of subjective pain in vaginal intercourse and monthly frequency of vaginal
intercourse obtained by telephone contact with the voluntary on one, six and twelve months
after the end of interventions. The data will be analyzed using Chi-square test of Pearson,
Fisher exact and Mann-Whitney. The beginning and end of treatment will be compared using the
Wilcoxon test (related samples) and McNemar (effect of the intervention), considering
statistical significance level of 5%. The software used is the statistical analysis software
(SAS) - Release 9.1, SAS Institute, Cary, North Carolina, USA, 2002-2003 and Statistical
Package for the Social Sciences (SPSS) -Release 17.0.
Phase:
Phase 3
Details
Lead Sponsor:
University of Campinas, Brazil
Treatments:
Amitriptyline Amitriptyline, perphenazine drug combination