Somatosensory Rehabilitation Program for Vestibulodynia

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Centre Hospitalier Universitaire de Sherbrooke, Sherbrooke, Canada
Vestibulodynia+2 More
Somatosensory Rehabilitation Program - Other
Eligibility
18 - 65
Female
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Study Summary

The feasibility and acceptability of a somatosensory rehabilitation program and an educational pain management program will be investigated in women with provoked vestibulodynia. Forty-four women will be randomized into the two groups. The secondary objective is to explore the effects of the somatosensory rehabilitation program compared to the pain management program. Each participant will receive 12 weekly sessions with a physiotherapist. The somatosensory rehabilitation program includes minimizing contact with the painful zone of the vulva and uses repeated tactile stimulation at a tolerated distance, proximal to the vulva. The pain management program includes teaching participants about vulvar hygiene, chronic pain mechanisms, relaxation techniques, and approaches to reduce skin irritations in painful regions. Participants in both groups will also receive advice on sexual function and steps toward resuming sexual activities with vaginal penetration. Feasibility and acceptability outcomes will be assessed and analyzed using descriptive statistics for the adherence rates to treatment sessions and home exercises, the recruitment rate, retention rate, satisfaction, and adverse effects. The results will be compared to predetermined thresholds to determine the feasibility and acceptability of a future clinical trial. Secondary measures will be assessed at baseline, two weeks after the treatment, and at three months follow-up. These outcomes will be assessed using validated questionnaires (pain, sexual function, global impression of change, psychological variables, quality of life) as well as evaluations of tactile and pressure sensitivity in vulvar regions using monofilaments, a 2-point aesthesiometer and an algometer. Linear mixed models for repeated measurements (2 groups, 3 measurement times) will be used to explore the treatment effects and will contribute to determining the feasibility of a future clinical trial. Hypothesis and expected results: It is expected that both programs will meet the pre-determined criteria for acceptability and feasibility in women with provoked vestibulodynia. This study will provide guidance for a future randomized clinical trial.

Eligible Conditions

  • Vestibulodynia

Treatment Effectiveness

Effectiveness Progress

1 of 3

Other trials for Vestibulodynia

Study Objectives

6 Primary · 19 Secondary · Reporting Duration: Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment

Month 3
Adverse events
Month 3
Patients' Global Impression of Change and Satisfaction
Month 3
Intervention Acceptability Questionnaire
At baseline only (before the initiation of the treatment)
Credibility and Expectancy Questionnaire
Short-Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS)
At baseline only (during the recruitement period)
Recruitment rate
Week 6
Self-Efficacy Question
Month 3
Adherence rate to assessment sessions
Retention rate
Change in the scores from pre- to 2-week post-treatment, and from pre-treatment to 3-month post-treatment
Vaginal Penetration Cognition Questionnaire (VPCQ)
Change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
12-item Short Form Survey (SF-12 v2)
Beck Depression Inventory questionnaire (BDI-II)
Female Sexual Distress Scale (FSDS)
Female Sexual Function Index (FSFI)
Pain Anxiety Symptoms Scale (PASS-20)
Pain Catastrophizing Scale (PCS)
Pain quality (McGill-Melzack questionnaire-short form)
Vulvar sensitivity
Change in the surface from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
Two-point discrimination test
Vulvar tactile alllodynia severity
Vulvar tactile allodynia area
Vulvar tactile sensibility
Changes from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment
Pain intensity during intercourse (Numerical Rating Scale)
From first to last session (baseline to 12th week)
Adherence rate to home exercises
Patients' adherence rate to treatment sessions
Therapists treatment adherence

Trial Safety

Safety Progress

1 of 3

Other trials for Vestibulodynia

Trial Design

2 Treatment Groups

Educational Pain Management Program (PMP)
1 of 2
Somatosensory Rehabilitation Program
1 of 2
Active Control
Experimental Treatment

44 Total Participants · 2 Treatment Groups

Primary Treatment: Somatosensory Rehabilitation Program · No Placebo Group · N/A

Somatosensory Rehabilitation Program
Other
Experimental Group · 1 Intervention: Somatosensory Rehabilitation Program · Intervention Types: Other
Educational Pain Management Program (PMP)
Other
ActiveComparator Group · 1 Intervention: Educational Pain Management Program · Intervention Types: Other

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: change in the scores from pre- to 2-week post-treatment, from 2-week post-treatment to 3-month post-treatment, and from pre-treatment to 3-month post-treatment

Trial Background

Prof. Mélanie Morin, Researcher and Full Professor
Principal Investigator
Université de Sherbrooke
Closest Location: Centre Hospitalier Universitaire de Sherbrooke · Sherbrooke, Canada
2005First Recorded Clinical Trial
2 TrialsResearching Vestibulodynia
72 CompletedClinical Trials

Eligibility Criteria

Age 18 - 65 · Female Participants · 2 Total Inclusion Criteria

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About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.