Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

Sponsor

Université de Sherbrooke (Other)

Overall Status

Completed

CT.gov ID

NCT01455350

Collaborator

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

212

Enrollment

Locations

Arms

Duration (Months)

106

Patients Per Site

2.2

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Vestibulodynia	Procedure: Multimodal physiotherapy Drug: lidocaine	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

212 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

Efficacy of Treatments for Provoked Vestivulodynia : a Randomised Clinical Trial Comparing Multimodal Physiotherapy Treatments to Topical Lidocaine

Study Start Date :

Oct 1, 2011

Actual Primary Completion Date :

Nov 1, 2015

Actual Study Completion Date :

Nov 1, 2015

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

Change in pain during intercourse [before treatment, after treatment, 6 months after treatment]
evaluated with a visual analog scale
Change in global sexual function [before treatment, after treatment, 6 months after treatment]
evaluated with the female sexual function index (FSFI)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 45 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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