Actively Recruiting
Efficacy of Dry Needling for Reducing Pain During Intercourse in Women With Provoked Vestibulodynia: A Multicenter Randomized Controlled Trial
Led by Université de Sherbrooke · Updated on 2026-05-12
170
Participants Needed
4
Research Sites
N/A
Total Duration
On this page
Sponsors
U
Université de Sherbrooke
Lead Sponsor
C
Centre de recherche du Centre hospitalier universitaire de Sherbrooke
Collaborating Sponsor
AI-Summary
What this Trial Is About
Chronic vulvar pain affects up to 16% of women and can be very distressing, especially provoked vestibulodynia (PVD), which causes sharp pain at the vaginal entrance during pressure or attempted penetration. Women with PVD often face psychological distress and disruptions in sexual function, with few effective treatment options available. This research aims to evaluate the use of dry needling (DN), a therapy targeting muscle tension, to reduce pain in women with PVD through a large randomized controlled trial. Participants will be randomly assigned to receive either real dry needling with needle penetration or sham dry needling with non-penetrating needles. Both treatments involve eight weekly sessions focused on the pelvic floor, hip, and lower back muscles, combined with education. This multicenter study compares these two approaches to establish whether dry needling can effectively reduce pain during intercourse in women with PVD. Women in the study will undergo assessments at the start, after treatment, and six months later. Researchers will measure changes in pain intensity during intercourse, pain quality, sexual function and distress, psychological factors like fear and catastrophizing, and pelvic floor muscle function and structure. Participants' satisfaction and perceptions of improvement will also be tracked to evaluate the treatment's impact and safety over time.
CONDITIONS
Brief Title
Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Women aged 18 to 45 years
- Women reporting vulvo-vaginal pain during intercourse for more than 3 months with an average pain intensity of 5 or higher on a numerical rating scale
- Confirmed diagnosis of provoked vestibulodynia by a gynecologist following a standardized exam
You will not qualify if you...
- Other urogynecological and vulvar pain conditions such as unprovoked pain, deep dyspareunia, or dermatological conditions
- Prior vulvovaginal or pelvic surgery
- Current pregnancy
- Postmenopausal status
- Previous dry needling or acupuncture treatments
- Expected changes in medication that could affect pain perception
- Significant medical conditions likely to interfere with study procedures
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 8 weeks
Participants receive real or sham dry needling applied to pelvic floor, hip, and lower back muscles along with education over eight consecutive weekly sessions.
Weekly visits for 8 weeks
Duration - 6 months
Participants are assessed for changes in pain, sexual function, quality of life, and treatment satisfaction after treatment completion.
2 visits (2-week and 6-month post-treatment evaluations)
Trial Site Locations
Total: 4 locations
1
Centre hospitalier universitaire de Québec - Université Laval
Québec, Quebec, Canada, G1V 4G2
Not Yet Recruiting
2
Kinatex l'Ormière
Québec, Quebec, Canada, G2B 3K3
Not Yet Recruiting
3
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec, Canada, J1H 5N4
Actively Recruiting
4
Cigonia
Sherbrooke, Quebec, Canada, J1L 1C6
Actively Recruiting
Research Team
C
Camille Simard, MSc
K
Kathryne Brûlé, MSc
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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