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Efficacy of Transcranial Direct-Current Stimulation (tDCS) for Provoked Vestibulodynia : a Triple Blind Randomized Controlled Trial

NCT02543593 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-05-02

No results posted yet for this study

Summary

Provoked vestibulodynia (PVD) is the most common form of vulvodynia and despite its high prevalence and important sexual, conjugal and psychological deleterious repercussions, effective evidence-based interventions remain limited. For a high proportion of women, significant pain persists despite the currently available treatments. Transcranial direct-current stimulation (tDCS) was shown to be effective in various chronic pain conditions. So far, only one case report study has shown significant pain reduction in women with vulvodynia. The main goal of this randomized controlled trial is to evaluate the efficacy of tDCS in women with PVD compared to sham tDCS. Forty women diagnosed with PVD, by a gynecologist following a standardized protocol will be randomized to either active or sham tDCS for ten 20 minute sessions of 2 mA stimulation over a 2-week period. Outcome measures will be collected at baseline, after treatment and at 3-month follow-up. The primary outcome is pain during intercourse assessed with a numerical rating scale (NRS). Secondary measurements focus on sexual function, vestibular pain sensitivity, psychological distress, treatment satisfaction and Patient Global Impression of Change (PGIC). The investigators expect that active tDCS treatment will significantly reduce pain during intercourse (post-treatment and 3-month follow-up compared to pre-treatment assessment). This trial will provide important information for determining the efficacy of a novel and promising intervention for women with PVD.

Conditions

  • Provoked Vestibulodynia

Interventions

DEVICE

Active tDCS or Sham tDCS

tDCS is a painless technique which consists in applying low direct-current through electrodes (one electrode serving as an anode, the other as a cathode) placed on the scalp to target the cerebral cortex. In patients with chronic pain, the anode is commonly placed over the motor cortex (M1) (Valeriani et al., 1999).

Sponsors & Collaborators

  • Centre de recherche du Centre hospitalier universitaire de Sherbrooke

    collaborator OTHER

  • Université de Sherbrooke

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
17 Years
Max Age
45 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-11-30
Primary Completion
2016-06-30
Completion
2016-11-30

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02543593 on ClinicalTrials.gov