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Dry Needling for Provoked Vestibulodynia
N/A
Recruiting
Led By Melanie Morin, PhD
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 through treatment completion (session 1 to 6; 6 weeks of treatment)
Summary
This trial studies the effects of dry needling to treat pelvic pain in women with provoked vestibulodynia. Participants randomized to receive real or sham needle therapy over 6 weeks, with outcomes measured.
Who is the study for?
This trial is for women with provoked vestibulodynia, experiencing moderate to severe pain during most sexual activities for at least three months. Participants should not be pregnant or have had vulvar surgery, other causes of vulvo-vaginal pain, post-menopausal state, fear of needles, or used dry needling/acupuncture before.
What is being tested?
The study tests the effectiveness of real versus sham (fake) dry needling in treating provoked vestibulodynia. Women will be randomly assigned to receive either 6 sessions of actual dry needling or sham needling over six weeks and evaluated on pain relief and psychosexual factors.
What are the potential side effects?
Potential side effects from dry needling may include temporary soreness at the needle site, minor bleeding or bruising. The sham procedure carries minimal risk since it does not penetrate the skin.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Adherence to treatment protocol
Adherence to treatment sessions
Adverse effects
+3 moreSecondary study objectives
Blinding effectiveness
Change in fear of pain
Change in pain catastrophizing
+12 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Experimental: Real Dry needlingExperimental Treatment1 Intervention
1 dry needling treatment per week for 6 consecutive weeks
Group II: Sham: Non penetrating dry needlingPlacebo Group1 Intervention
1 non penetrating dry needling per week for 6 consecutive weeks
Find a Location
Who is running the clinical trial?
Josiane ParéUNKNOWN
Nathaly GaudreaultUNKNOWN
Nathalie J. BureauUNKNOWN
Mélanie RochUNKNOWN
Université de SherbrookeLead Sponsor
307 Previous Clinical Trials
77,578 Total Patients Enrolled
6 Trials studying Vulvodynia
552 Patients Enrolled for Vulvodynia
Melanie Morin, PhDPrincipal InvestigatorUniversité de Sherbrooke
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have gone through menopause.I haven't changed my pain or mood medication in the last 3 months.I have previously received dry needling or acupuncture treatments.I experience significant pain during sex, rating it 5 or more out of 10.I have severe pelvic organ prolapse or had a urinary/vaginal infection recently.I have had surgery on my vulva, vagina, or pelvis before.I have been diagnosed with provoked vestibulodynia by a gynecologist.I have vulvo-vaginal pain not caused by sex, skin conditions, herpes, or thinning tissues.
Research Study Groups:
This trial has the following groups:- Group 1: Experimental: Real Dry needling
- Group 2: Sham: Non penetrating dry needling
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.