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

NCT02543593 | Completed

• 1 other identifier: 14-169
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

tDCS

Outcome Measures

Primary Outcomes (1)

• Pain during intercourse (Numeric rating scale)

  Pain during intercourse will be assessed using a numeric rating scale (NRS) ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever. This method for measuring pain has been shown to detect significant treatment effects in women with PVD and demonstrates a significant positive correlation with other pain intensity measures. Pain during intercourse is the main symptom of PVD and the one that most interferes with quality of life, hence the most relevant measure of functional outcome (Bergeron et al., 2008; Bergeron et al., 2001; Morin et al., 2010; Morin et al., 2011).

  Change in the NRS scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment

Secondary Outcomes (9)

• Pain (McGill-Melzack questionnaire)

  Change in the McGill-Melzack scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment

• Vestibular sensitivity (algometer)

  Change in the pain threshold and pain tolerance scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment

• Female Sexual Function Index (FSFI)

  Change in the FSFI scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment

• Pain Catastrophizing Scale (PCS)

  Change in the PCS scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment

• Spielberg State-Trait Anxiety Inventory (IASTA)

  Change in the IASTA state and IASTA trait scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment

Study Arms (2)

Intervention

EXPERIMENTAL

Participants will receive active transcranial direct-current stimulation (tDCS) for ten 20 minute sessions of 2 mA stimulation over a 2-week period.

Device: Active tDCS or Sham tDCS

Placebo

SHAM COMPARATOR

Participants will receive sham transcranial direct-current stimulation (tDCS) for ten 20 minute sessions of 2 mA stimulation over a 2-week period.

Device: Active tDCS or Sham tDCS

Interventions

Active tDCS or Sham tDCS DEVICE

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).

Also known as: neuroConn; Model no: 0008; Serial no:0169

Intervention; Placebo

Eligibility Criteria

• Age: 17 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Experience moderate to severe pain in at least 90% of attempted sexual intercourse;
• Experience moderate to severe pain during cotton swab test, in one or more regions of the vestibule (minimum of 5/10 on a subjective numeric scale of pain intensity);
• Pain limited to the vestibule during vaginal intercourse and during activities exerting pressure on the vestibule (tampon insertion, tight jeans or pants, cycling, horseback riding);
• Presence of PVD for at least 6 months and diagnosed according to the standardized gynecological examination protocol by one of our staff gynecologists;
• Have a stable sexual partner with regular sexual activity including penetration.

You may not qualify if:

• Other pelvic pathology associated with pelvic pain (e.g., deep dyspareunia);
• Chronic pain conditions (e.g. fibromyalgia, low back pain, chronic migraines);
• Use of medication that can influence the perception of pain (eg analgesic, opioids, antiepileptic, muscle relaxant);
• Pregnancy for less than one year and breastfeeding;
• Anterior vulvar or vaginal surgery;
• Refusal to refrain from other treatments one month prior to first treatment study until the last 3-month follow-up assessment;
• Important urogynecologic symptoms (urinary or anal incontinence, urinary urgency, pelvic organ prolapse, active urinary tract or vaginal infection or earlier in the last 3 months, etc.);
• Contraindications to tDCS (e.g. metallic implant in or near the skull, history of epilepsy, pacemaker);
• Previously received tDCS treatment.

Sponsors & Collaborators

• Université de Sherbrooke: lead
• Centre de recherche du Centre hospitalier universitaire de Sherbrooke: collaborator

Study Sites (2)

Centre hospitalier Universitaire de Sherbroke

Sherbrooke, Quebec, J1H 5n4, Canada

Location

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H 5N4, Canada

Location

Related Publications (1)

• Morin A, Leonard G, Gougeon V, Waddell G, Bureau YA, Girard I, Morin M. Efficacy of transcranial direct-current stimulation (tDCS) in women with provoked vestibulodynia: study protocol for a randomized controlled trial. Trials. 2016 May 14;17(1):243. doi: 10.1186/s13063-016-1366-5.

  PMID: 27179944 DERIVED

Related Links

• Facebook page
• Laboratory Web page

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: pht, PhD

Study Record Dates

• First Submitted: September 4, 2015
• First Posted: September 7, 2015
• Study Start: November 1, 2014
• Primary Completion: June 1, 2016
• Study Completion: November 1, 2016
• Last Updated: May 2, 2017

Record last verified: 2017-05

Locations

CA (2)