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

NCT ID: NCT02543593

Last Updated: 2017-05-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-11-30
• Study Completion Date: 2016-11-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention

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

Group Type: EXPERIMENTAL

Active tDCS or Sham tDCS

Intervention Type: 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).

Placebo

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

Group Type: SHAM_COMPARATOR

Active tDCS or Sham tDCS

Intervention Type: 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).

Interventions

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).

Intervention Type: DEVICE

Other Intervention Names

neuroConn; Model no: 0008; Serial no:0169

Eligibility Criteria

Inclusion Criteria

1. Experience moderate to severe pain in at least 90% of attempted sexual intercourse;

2. 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);

3. 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);

4. Presence of PVD for at least 6 months and diagnosed according to the standardized gynecological examination protocol by one of our staff gynecologists;

5. Have a stable sexual partner with regular sexual activity including penetration.

Exclusion Criteria

1. Other pelvic pathology associated with pelvic pain (e.g., deep dyspareunia);

2. Chronic pain conditions (e.g. fibromyalgia, low back pain, chronic migraines);

3. Use of medication that can influence the perception of pain (eg analgesic, opioids, antiepileptic, muscle relaxant);

4. Pregnancy for less than one year and breastfeeding;

5. Anterior vulvar or vaginal surgery;

6. Refusal to refrain from other treatments one month prior to first treatment study until the last 3-month follow-up assessment;

7. 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.);

8. Contraindications to tDCS (e.g. metallic implant in or near the skull, history of epilepsy, pacemaker);

9. Previously received tDCS treatment.

• Minimum Eligible Age: 17 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

OTHER

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Mélanie Morin

pht, PhD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centre hospitalier Universitaire de Sherbroke

Sherbrooke, Quebec, Canada

Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 27179944 (View on PubMed)

Related Links

https://www.facebook.com/pages/Laboratoire-de-recherche-en-urogyn%C3%A9cologie/277240805641504?fref=ts

Facebook page

http://www.lab-urogyn.com/

Laboratory Web page

Other Identifiers

14-169

Identifier Type: -

Identifier Source: org_study_id