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Efficacy of a Physiotherapy Treatment in Women Suffering From Provoked Vestibulodynia

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2014 by Université de Sherbrooke
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
ClinicalTrials.gov Identifier:
NCT01455350
First received: October 13, 2011
Last updated: January 29, 2014
Last verified: January 2014
  Purpose

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 Intervention
Vestibulodynia
Procedure: Multimodal physiotherapy
Drug: lidocaine

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy of Treatments for Provoked Vestivulodynia : a Randomised Clinical Trial Comparing Multimodal Physiotherapy Treatments to Topical Lidocaine

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

Primary Outcome Measures:
  • Change in pain during intercourse [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated with a visual analog scale

  • Change in global sexual function [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated with the female sexual function index (FSFI)


Secondary Outcome Measures:
  • Change in pain catastrophizing [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated using the pain catastrophizing scale

  • Change in psychologic distress [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated using the State-trait Anxiety Inventory (STAI)

  • Change in fear of pain [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated using the Pain Anxiety Symptoms Scale (PASS-20)

  • Change in vulvar blood circulation [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated using a doppler laser

  • Change in pelvic floor muscles function [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated using transperineal ultrasound and dynamometry

  • Change in pain sensitivity (pressure pain) [ Time Frame: before treatment, after treatment, 6 months after treatment ] [ Designated as safety issue: No ]
    evaluated using a vulvagesiometer


Estimated Enrollment: 234
Study Start Date: October 2011
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Lidocaine
10 week treatment of daily application of topical lidocaine
Drug: 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.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01455350

Contacts
Contact: Melanie Morin, Pht, Ph.D. 819-346-1110 ext 13818 melanie.m.morin@usherbrooke.ca

Locations
Canada, Quebec
University of Montreal Recruiting
Montreal, Quebec, Canada, H3C 3T5
Contact: Melanie Morin, Ph.D. (c)    819-346-1110 ext 18439    memorin.chus@ssss.gouv.qc.ca   
Principal Investigator: Melanie Morin, Pht, Ph.D.         
Centre Hospitalier Universitaire de Sherbrooke Recruiting
Sherbrooke, Quebec, Canada, J1H 5N4
Contact: Melanie Morin, Ph.D.    819-346-1110 ext 18439    memorin.chus@ssss.gouv.qc.ca   
Principal Investigator: Melanie Morin, Pht, Ph.D.         
Sponsors and Collaborators
Université de Sherbrooke
Canadian Institutes of Health Research (CIHR)
Fonds de la Recherche en Santé du Québec
Investigators
Principal Investigator: Melanie Morin, Pht, Ph.D. University of Sherbrooke
  More Information

No publications provided

Responsible Party: Mélanie Morin, Physiotherapist, PhD, Université de Sherbrooke
ClinicalTrials.gov Identifier: NCT01455350     History of Changes
Other Study ID Numbers: MOP-115028
Study First Received: October 13, 2011
Last Updated: January 29, 2014
Health Authority: Canada: Ethics Review Committee

Keywords provided by Université de Sherbrooke:
provoked vestibulodynia
multimodal physiotherapy
lidocaine

Additional relevant MeSH terms:
Vulvodynia
Genital Diseases, Female
Vulvar Diseases
Lidocaine
Anesthetics
Anesthetics, Local
Anti-Arrhythmia Agents
Cardiovascular Agents
Central Nervous System Agents
Central Nervous System Depressants
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Sodium Channel Blockers
Therapeutic Uses
Voltage-Gated Sodium Channel Blockers

ClinicalTrials.gov processed this record on November 25, 2014