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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 weeks
Treatment ~ Varies
Follow Up ~baseline
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

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 more
Secondary study objectives
Blinding effectiveness
Change in fear of pain
Change in pain catastrophizing
+12 more

Trial 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

Media Library

Dry needling (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05797480 — N/A
Vulvodynia Research Study Groups: Experimental: Real Dry needling, Sham: Non penetrating dry needling
Vulvodynia Clinical Trial 2023: Dry needling Highlights & Side Effects. Trial Name: NCT05797480 — N/A
Dry needling (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05797480 — N/A
~2 spots leftby Dec 2024
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