Multimodal physiotherapy
Procedure10 weeks of weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises.
NCT Number: NCT01455350
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).
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Notify Me18 year–45 year
Female
Interventional
Not applicable
University of Montreal, Montreal, Quebec, Canada
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
10 weeks of weekly physiotherapy treatments including relaxation techniques, stretching and pelvic floor muscle control exercises.
10 weeks of daily topical 5% lidocaine application
Other names: Xylocaine
Time frame: before treatment, after treatment, 6 months after treatment
evaluated with a visual analog scale
Time frame: before treatment, after treatment, 6 months after treatment
evaluated with the female sexual function index (FSFI)
Time frame: before treatment, after treatment, 6 months after treatment
evaluated using the pain catastrophizing scale
Time frame: before treatment, after treatment, 6 months after treatment
evaluated using the State-trait Anxiety Inventory (STAI)
Time frame: before treatment, after treatment, 6 months after treatment
evaluated using the Pain Anxiety Symptoms Scale (PASS-20)
Time frame: before treatment, after treatment, 6 months after treatment
evaluated using a doppler laser
Time frame: before treatment, after treatment, 6 months after treatment
evaluated using transperineal ultrasound and dynamometry
Time frame: before treatment, after treatment, 6 months after treatment
evaluated using a vulvagesiometer
Université de Sherbrooke
Other
Efficacy of Treatments for Provoked Vestivulodynia : a Randomised Clinical Trial Comparing Multimodal Physiotherapy Treatments to Topical Lidocaine
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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