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Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

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ClinicalTrials.gov Identifier: NCT01455350
Recruitment Status : Completed
First Posted : October 19, 2011
Last Update Posted : November 4, 2016
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

Tracking Information
First Submitted Date  ICMJE October 13, 2011
First Posted Date  ICMJE October 19, 2011
Last Update Posted Date November 4, 2016
Study Start Date  ICMJE October 2011
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 17, 2011)
  • Change in pain during intercourse [ Time Frame: before treatment, after treatment, 6 months after treatment ]
    evaluated with a visual analog scale
  • Change in global sexual function [ Time Frame: before treatment, after treatment, 6 months after treatment ]
    evaluated with the female sexual function index (FSFI)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01455350 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 17, 2011)
  • Change in pain catastrophizing [ Time Frame: before treatment, after treatment, 6 months after treatment ]
    evaluated using the pain catastrophizing scale
  • Change in psychologic distress [ Time Frame: before treatment, after treatment, 6 months after treatment ]
    evaluated using the State-trait Anxiety Inventory (STAI)
  • Change in fear of pain [ Time Frame: before treatment, after treatment, 6 months after treatment ]
    evaluated using the Pain Anxiety Symptoms Scale (PASS-20)
  • Change in vulvar blood circulation [ Time Frame: before treatment, after treatment, 6 months after treatment ]
    evaluated using a doppler laser
  • Change in pelvic floor muscles function [ Time Frame: before treatment, after treatment, 6 months after treatment ]
    evaluated using transperineal ultrasound and dynamometry
  • Change in pain sensitivity (pressure pain) [ Time Frame: before treatment, after treatment, 6 months after treatment ]
    evaluated using a vulvagesiometer
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia
Official Title  ICMJE Efficacy of Treatments for Provoked Vestivulodynia : a Randomised Clinical Trial Comparing Multimodal Physiotherapy Treatments to Topical Lidocaine
Brief Summary 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).
Detailed Description 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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Vestibulodynia
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • 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
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 3, 2016)
212
Original Estimated Enrollment  ICMJE
 (submitted: October 17, 2011)
234
Actual Study Completion Date  ICMJE November 2015
Actual Primary Completion Date November 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01455350
Other Study ID Numbers  ICMJE MOP-115028
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Mélanie Morin, Université de Sherbrooke
Study Sponsor  ICMJE Université de Sherbrooke
Collaborators  ICMJE
  • Canadian Institutes of Health Research (CIHR)
  • Fonds de la Recherche en Santé du Québec
Investigators  ICMJE
Principal Investigator: Melanie Morin, Pht, Ph.D. Université de Sherbrooke
PRS Account Université de Sherbrooke
Verification Date November 2016

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