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Somatosensory Rehabilitation Program for Vulvodynia

N/A
Waitlist Available
Research Sponsored by Université de Sherbrooke
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 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
Awards & highlights

Study Summary

This trial is investigating the feasibility and acceptability of a somatosensory rehabilitation program and an educational pain management program for women with provoked vestibulodynia. The results will be used to determine the feasibility of a future clinical trial.

Eligible Conditions
  • Vulvodynia

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 2-week post-treatment and 3 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 2-week post-treatment and 3 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Adherence rate to assessment sessions
Adherence rate to home exercises
Patients' adherence rate to treatment sessions
+3 more
Secondary outcome measures
12-item Short Form Survey (SF-12 v2)
Adverse events
Beck Depression Inventory questionnaire (BDI-II)
+16 more
Other outcome measures
Short-Leeds Assessment for Neuropathic Symptoms and Signs (S-LANSS)

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: Somatosensory Rehabilitation ProgramExperimental Treatment1 Intervention
Includes minimizing contact with the painful zone of the vulva and uses tactile stimulation at a tolerated distance from the vulva. Each participant will also receive advice on resuming sexual activities with vaginal penetration.
Group II: Educational Pain Management Program (PMP)Active Control1 Intervention
Includes education on decreasing irritative contacts with the vulva and relaxation techniques. Each participant will also receive advice on resuming sexual activities with vaginal penetration.

Find a Location

Who is running the clinical trial?

Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,343 Previous Clinical Trials
26,453,048 Total Patients Enrolled
1 Trials studying Vulvodynia
212 Patients Enrolled for Vulvodynia
Centre de recherche du Centre hospitalier universitaire de SherbrookeOTHER
58 Previous Clinical Trials
31,120 Total Patients Enrolled
3 Trials studying Vulvodynia
223 Patients Enrolled for Vulvodynia
Université de SherbrookeLead Sponsor
292 Previous Clinical Trials
69,396 Total Patients Enrolled
6 Trials studying Vulvodynia
553 Patients Enrolled for Vulvodynia

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Does this clinical research include participants that are over 20 years of age?

"The age criteria for this research are 18-45 years old."

Answered by AI

Is there still time to join this research experiment?

"Evidence on clinicaltrials.gov suggests that recruitment for this medical trial has ceased, with the initial posting occurring May 16th 2022 and last update happening October 31st 2022. At present, there are no active searches; however, 10 other trials are currently recruiting patients."

Answered by AI

Does my profile meet the requirements to join this experiment?

"This clinical trial seeks 44 individuals aged 18 to 45 years old with a verified diagnosis of vestibulodynia. In addition, these participants must have experienced moderate to intense (at least 5/10 on the pain scale) in their vulvar vestibule for at least 3 months, during most vaginal penetrations or activities that involve pressure being applied to the vagina."

Answered by AI

What is the ultimate objective of this research?

"This trial aims to assess patient adherence rates over a 12-week period. Secondary endpoints include Two-point Discrimination Test, Credibility and Expectancy Questionnaire, and Vulvar Tactile Allodynia Severity (VTAS). VTAS involves the use of seven monofilaments with various force levels being applied to the outside border of a participant's vulvar vestibule to determine their sensitivity threshold. The result is expressed as the minimum pressure required for an increase in discomfort, with lower values indicating more severe allodynia. Meanwhile, the Credibility and Acceptability Questionnaire examines participants' expectations by measuring 3 criteria"

Answered by AI
~15 spots leftby Apr 2025