Testing Real dry needling against a placebo for provoked vestibulodynia
Official title: Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse
Efficacy of Dry Needling for Reducing Pain During Intercourse in Women With Provoked Vestibulodynia: A Multicenter Randomized Controlled Trial
- 2 groups
- Sites in Québec and Sherbrooke
- Recruiting
Interventions
- Other intervention
Real dry needling
The intervention will consist of real dry needling applied to the pelvic floor, hip, and lower back muscles, accompanied by an education component, delivered over eight consecutive weekly sessions.
- Other intervention
Sham dry needling
The same treatment regimen will be applied using sham, non-penetrating, needles.
Canadian Sites (4)
2 of 4 recruiting
- Recruiting
Centre hospitalier universitaire de Sherbrooke
Sherbrooke, Quebec
- Recruiting
Cigonia
Sherbrooke, Quebec
- Not yet recruiting
Centre hospitalier universitaire de Québec - Université Laval
Québec, Quebec
- Not yet recruiting
Kinatex l'Ormière
Québec, Quebec
Eligibility Criteria
See who this study is looking for9 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Women reporting vulvo-vaginal pain during intercourse for \>3 months with an average pain intensity of ≥5/10 on a numerical rating scale (NRS);
- +Confirmed diagnosis of provoked vestibulodynia by a gynecologist of our team following a standardized gynaecologic exam.
Exclusion
- −Other urogynecological and vulvar pain conditions (e.g., unprovoked pain, deep dyspareunia, dermatological condition);
- −Postmenopausal status;
- −Having previously received DN or acupuncture;
- −Expected changes of medication that could influence pain perception (e.g., antidepressant);
- −Any significant coexisting medical conditions likely to interfere with the study procedures.
- −Current pregnancy;
- −Prior vulvovaginal or pelvic surgery;
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
This study is not organised into the usual phase numbers — that is common for device, behavioural, and diagnostic research.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A receives Real dry needling.
Registry label: A: Real dry needling
Group B, the shamSham procedureA procedure made to feel like the real one, without the active step.Read more → group, receives Sham dry needling.
Registry label: B: Sham dry needling
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a sham procedureSham procedureA procedure made to feel like the real one, without the active step.Read more → — one made to feel like the real thing but without the active step.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 18 years to 45 years.
The study lists female participants only.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 170 people.
The study is currently expected to finish around June 2029.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT07534345 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Real dry needlingOther
The intervention will consist of real dry needling applied to the pelvic floor, hip, and lower back muscles, accompanied by an education component, delivered over eight consecutive weekly sessions.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
About Sham dry needlingOther
The same treatment regimen will be applied using sham, non-penetrating, needles.
From the trial registry — its own words, unedited.
What a other is here: An intervention the registry did not place in another category.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 18 years to 45 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study includes a shamSham procedureA procedure made to feel like the real one, without the active step.Read more → comparison — a procedure made to feel like the real one, without the active step.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 18 years to 45 years.
It lists female participants only.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more →, 2-week post-treatment evaluation, 6-month follow-upFollow-upContinued check-ins after the treatment part is finished.Read more → assessment.
The study as a whole is currently expected to finish around 2029-06.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 170 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 2 locations, including: Québec, Quebec, Canada; Sherbrooke, Quebec, Canada.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
Chronic vulvar pain is a highly prevalent and debilitating condition affecting up to 16% of women. The most common subtype of vulvar pain, provoked vestibulodynia (PVD), is characterized by a sharp pain at the entry of the vagina in response to pressure or attempted vaginal penetration. Women with PVD not only present with psychological distress and significant disruption in all aspects of sexual function, but they are also confronted with limited effective treatment options. Dry needling (DN) could fill this therapeutic gap. Similar to acupuncture, this approach involves the insertion of fine needles into the tissues. However, its mechanisms of action are quite different. DN specifically targets muscle tension/stiffness, which has been shown to play a key role in PVD. After designing a DN treatment protocol tailored to the affected muscles in PVD, our randomized pilot study confirmed that our state-of-the-art DN treatment protocol is feasible and acceptable for treating PVD and the promising findings obtained provide support for conducting the proposed large-scale study. The proposed multicenter randomized controlled trial aims to establish the efficacy of DN for reducing pain in women with PVD. Women will be randomized to receive either sham or real DN for 8 weekly sessions. Validated outcome measures will be assessed at baseline, post-treatment and at the 6-month follow-up. The current proposal addresses the urgent need to develop novel treatment options for women with PVD. If proven effective, DN could be proposed as a first-line low-risk treatment.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.