Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia
This study has been completed.
First Posted: October 19, 2011
Last Update Posted: November 4, 2016
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Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Mélanie Morin, Université de Sherbrooke
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).
Procedure: Multimodal physiotherapy
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
||Efficacy of Treatments for Provoked Vestivulodynia : a Randomised Clinical Trial Comparing Multimodal Physiotherapy Treatments to Topical Lidocaine
Primary Outcome Measures:
Secondary Outcome Measures:
- 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
| Study Start Date:
| Study Completion Date:
| Primary Completion Date:
||November 2015 (Final data collection date for primary outcome measure)
Active Comparator: Lidocaine
10 week treatment of daily application of topical lidocaine
10 weeks of daily topical 5% lidocaine application
Other Name: 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.
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.