Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

November 3, 2016 updated by: Mélanie Morin, Université de Sherbrooke

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

212

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3C 3T5
        • University of Montreal
      • Sherbrooke, Quebec, Canada, J1H 5N4
        • Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Lidocaine
10 week treatment of daily application of topical lidocaine
Drug: lidocaine
10 weeks of daily topical 5% lidocaine application
Other Names:
  • Xylocaine
Experimental: Multimodal physiotherapy
10 weeks of weekly multimodal physiotherapy treatments
Procedure: Multimodal physiotherapy
10 weeks of weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain during intercourse
Time Frame: before treatment, after treatment, 6 months after treatment
evaluated with a visual analog scale
before treatment, after treatment, 6 months after treatment
Change in global sexual function
Time Frame: before treatment, after treatment, 6 months after treatment
evaluated with the female sexual function index (FSFI)
before treatment, after treatment, 6 months after treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in pain catastrophizing
Time Frame: before treatment, after treatment, 6 months after treatment
evaluated using the pain catastrophizing scale
before treatment, after treatment, 6 months after treatment
Change in psychologic distress
Time Frame: before treatment, after treatment, 6 months after treatment
evaluated using the State-trait Anxiety Inventory (STAI)
before treatment, after treatment, 6 months after treatment
Change in fear of pain
Time Frame: before treatment, after treatment, 6 months after treatment
evaluated using the Pain Anxiety Symptoms Scale (PASS-20)
before treatment, after treatment, 6 months after treatment
Change in vulvar blood circulation
Time Frame: before treatment, after treatment, 6 months after treatment
evaluated using a doppler laser
before treatment, after treatment, 6 months after treatment
Change in pelvic floor muscles function
Time Frame: before treatment, after treatment, 6 months after treatment
evaluated using transperineal ultrasound and dynamometry
before treatment, after treatment, 6 months after treatment
Change in pain sensitivity (pressure pain)
Time Frame: before treatment, after treatment, 6 months after treatment
evaluated using a vulvagesiometer
before treatment, after treatment, 6 months after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Sherbrooke

Collaborators

Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec

Investigators

  • Principal Investigator: Melanie Morin, Pht, Ph.D., Université de Sherbrooke

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (Actual)

November 1, 2015

Study Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

October 13, 2011

First Submitted That Met QC Criteria

October 17, 2011

First Posted (Estimate)

October 19, 2011

Study Record Updates

Last Update Posted (Estimate)

November 4, 2016

Last Update Submitted That Met QC Criteria

November 3, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MOP-115028

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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