Physical Therapy as Adjuvant Treatment of Vulvodynia: a Randomized Controled Trial

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.

Conditions

• Vulvodynia

Interventions

DRUG

Amitriptyline

Volunteers will take 25 milligrams of this medication every day from their enrollment until completing eight weeks long.

OTHER

Kinesiotherapy

Volunteers will be taught to contract their pelvic floor muscles right before stretching it, following a home protocol, every day for eight weeks long.

DEVICE

IC (Quark)

Volunteers will visit physical therapy clinic once a week to receive twenty minutes of electrical stimulation with Interferential Current (Duapex 961 of Quark Medical manufacturer) in their perineal area, for eight weeks long.

Sponsors & Collaborators

• University of Campinas, Brazil

  lead OTHER

Principal Investigators

• Paulo C Giraldo, MD, PhD · University of Campinas, Brazil

• Marcela G Bardin, PT, Master · University of Campinas, Brazil

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-07-31

Primary Completion

2017-10-31

Completion

2017-12-31

Countries

• Brazil

Study Locations