Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Université de Sherbrooke
Sponsor:
Collaborators:
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Mélanie Morin, Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT01455350
First received: October 13, 2011
Last updated: January 29, 2014
Last verified: January 2014

October 13, 2011
January 29, 2014
October 2011
October 2015   (final data collection date for primary outcome measure)
  • Change in pain during intercourse [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated with a visual analog scale
  • Change in global sexual function [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated with the female sexual function index (FSFI)
Same as current
Complete list of historical versions of study NCT01455350 on ClinicalTrials.gov Archive Site
  • Change in pain catastrophizing [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated using the pain catastrophizing scale
  • Change in psychologic distress [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated using the State-trait Anxiety Inventory (STAI)
  • Change in fear of pain [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated using the Pain Anxiety Symptoms Scale (PASS-20)
  • Change in vulvar blood circulation [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated using a doppler laser
  • Change in pelvic floor muscles function [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated using transperineal ultrasound and dynamometry
  • Change in pain sensitivity (pressure pain) [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated using a vulvagesiometer
Same as current
Not Provided
Not Provided
 
Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia
Efficacy of Treatments for Provoked Vestivulodynia : a Randomised Clinical Trial Comparing Multimodal Physiotherapy Treatments to Topical Lidocaine

Chronic gynaecological pain is a major medical problem that affects 20-30% of women at different moments of their life. This largely neglected issue has a significant impact on the sexual and conjugal life of women suffering from it as well as on their psychological health. Furthermore, this kind of pain is not well understood, often misdiagnosed or even totally ignored. Also, treatment is limited and not extensively studied. This study aims at better understanding and treating gynaecological pain. The focus of the study will be provoked vestibulodynia, pain at the entry of the vagina. The efficacy of specialized pelvic floor physiotherapy will be compared to a topical cream (lidocaine) applied to the vulva. The treatment efficacy will be assessed in 234 women (aged from 18-45 years old) suffering from provoked vestibulodynia recruited in 4 hospitals (CHUS, Jewish General Hospital, Royal-Victoria Hospital, CHUM St-Luc).

This is a randomised controlled trial comparing the impact of multimodal physiotherapy treatments to topical lidocaine in women suffering from provoked vestibulodyina. The first treatment consists of 10 sixty minutes weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises. The second treatment is a night time application of lidocaine to the vulva for 10 weeks. Physiotherapists will then evaluate women's pain and sexual function right after the treatment and 6 months later.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Vestibulodynia
  • Procedure: Multimodal physiotherapy
    10 weeks of weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises.
  • Drug: lidocaine
    10 weeks of daily topical 5% lidocaine application
    Other Name: Xylocaine
  • Active Comparator: Lidocaine
    10 week treatment of daily application of topical lidocaine
    Intervention: Drug: lidocaine
  • Experimental: Multimodal physiotherapy
    10 weeks of weekly multimodal physiotherapy treatments
    Intervention: Procedure: Multimodal physiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
234
October 2015
October 2015   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • Moderate to severe pain in at least 90% of sexual intercourses.
  • Moderate to severe pain during the cotton-swab test at one of more vestibule regions (5/10 minimum pain evaluation on the verbal pain intensity scale).
  • Pain limited to the vestibule during vaginal penetrations and during activities applying pressure on the vestibule.
  • Provoked vestibulodynia lasting at least 6 months prior to the study and diagnosed by a standardised gynaecologic exam protocol by one of our collaborator.

Exclusion Criteria:

  • Major psychiatric condition or pelvic pathology associated with a genital pain problem (e.g.: dyspareunia).
  • Use of medication that could influence pain perception.
  • Actual or past pregnancy.
  • Vulvar or vaginal surgery
  • Post-menopausal state
  • Unwillingness to restrain from other treatments till the 6 months post-treatment evaluation.
  • Urogynaecologic symptoms (urinary/anal incontinence, pelvic organs prolapsus, urinary/vaginal infection active or during the last 3 months).
  • Incapacity to have sexual intercourse including vaginal penetration during the last 6 months.
  • Physiotherapy treatments or lidocaine application prior to the study
Female
18 Years to 45 Years
No
Contact: Melanie Morin, Pht, Ph.D. 819-346-1110 ext 13818 melanie.m.morin@usherbrooke.ca
Canada
 
NCT01455350
MOP-115028
No
Mélanie Morin, Université de Sherbrooke
Université de Sherbrooke
  • Canadian Institutes of Health Research (CIHR)
  • Fonds de la Recherche en Santé du Québec
Principal Investigator: Melanie Morin, Pht, Ph.D. University of Sherbrooke
Université de Sherbrooke
January 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP