Dry Needling for Vulvodynia

Not yet recruiting at 3 trial locations

Overseen By Camille Simard, MSc

Age: 18 - 65

Sex: Female

Trial Phase: Academic

Sponsor: Université de Sherbrooke

Must not be taking: Antidepressants

Disqualifiers: Other pain conditions, Prior surgery, Pregnancy, Postmenopausal, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 10

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether dry needling can effectively reduce chronic vulvar pain, specifically provoked vestibulodynia (PVD), which causes sharp pain at the vaginal entrance during pressure or attempted penetration. Participants will receive either real dry needling, using fine needles to target muscle tension, or a sham version with non-penetrating needles, over eight weekly sessions. The researchers aim to determine if real dry needling can become a low-risk, first-line treatment for PVD. Women experiencing vulvo-vaginal pain during intercourse for more than three months, with a pain intensity of 5 or higher on a 10-point scale, might be a good fit for this trial. As an unphased trial, this study offers a unique opportunity to contribute to pioneering research that could lead to new treatment options for PVD.

What prior data suggests that dry needling is safe for treating vulvodynia?

Studies have shown that dry needling is generally safe and well-tolerated for women with provoked vestibulodynia (PVD), a condition causing chronic vulvar pain. Research indicates that this treatment is practical and acceptable for managing this type of pain. In previous trials, participants did not report any major side effects, suggesting that the treatment carries low risk. Dry needling involves inserting fine needles into specific muscles, similar to acupuncture, and aims to relieve muscle tension. This method has been used successfully for other types of muscle pain and appears safe for PVD as well. Available data indicate that many people have benefited from this approach without experiencing significant side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about dry needling for vulvodynia because it offers a unique, non-pharmacological approach to managing this chronic pain condition. Unlike traditional treatments that often involve medication or surgery, dry needling uses thin needles to target trigger points in muscles, potentially providing relief by altering nerve signaling and muscle tension. This technique could offer a new option for patients seeking pain relief without the side effects associated with medications, and the possibility of a more direct, localized treatment is a promising development for those affected by vulvodynia.

What evidence suggests that dry needling might be an effective treatment for vulvodynia?

Research has shown that dry needling (DN) can help reduce pain for women with provoked vestibulodynia (PVD). One study found that women who received DN reported significantly less pain than those who received a sham treatment, with an average difference of 2.4 points on a pain scale. This trial will compare real dry needling, which involves penetrating needles, with sham dry needling, using non-penetrating needles, over 8 consecutive weekly sessions. Another study demonstrated that DN also significantly reduced pain during sex. These findings suggest that DN, which relieves muscle tension and stiffness, could be a promising treatment for PVD. ^{1 3 4 6 7}

Who Is on the Research Team?

Mélanie Morin

Principal Investigator

Université de Sherbrooke

Are You a Good Fit for This Trial?

Inclusion Criteria

I have been diagnosed with provoked vestibulodynia by this team's gynecologist.

I have had vulvo-vaginal pain during sex for over 3 months, with pain rated 5 or higher out of 10.

Exclusion Criteria

I am postmenopausal.

I have received dry needling or acupuncture before.

Current pregnancy

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either sham or real dry needling for 8 consecutive weekly sessions

8 weeks

8 visits (in-person)

Post-treatment evaluation

Assessment of outcome measures 2 weeks after treatment completion

2 weeks

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness 6 months after treatment

6 months

1 visit (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dry Needling

How Is the Trial Designed?

Group I: Real dry needling Experimental Treatment 1 Intervention

Real dry needling, i.e., penetrating needles, for 8 consecutive weekly sessions.

Group II: Sham dry needling Placebo Group 1 Intervention

Sham dry needling, i.e., non-penetrating needles, for 8 consecutive weekly sessions.

Who Is Running the Clinical Trial?

Université de Sherbrooke

Lead Sponsor

Trials

317

Recruited

79,300+

Kinatex l'Ormière

Collaborator

Trials

1

Recruited

140+

Centre de recherche du Centre hospitalier universitaire de Sherbrooke

Collaborator

Trials

64

Recruited

33,600+

Cigonia

Collaborator

CHU de Quebec-Universite Laval

Collaborator

Trials

177

Recruited

110,000+

Citations

1.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/41207407/

A randomized controlled trial investigating feasibility ...

The realDN group showed a significant decrease in pain intensity compared to the shamDN group (mean difference between groups 2.4; 95%CI 1.4-3.3 ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2772973725007830

Dry needling to treat provoked vestibulodynia: results of a ...

This study's findings support DN's feasibility and acceptability in treating women with PVD. They also demonstrated a clinically and statistically significant ...

3.

jpain.org

jpain.org/article/S1526-5900(25)00823-5/fulltext

A randomized controlled trial investigating feasibility ...

Importantly, the results revealed a statistically and clinically significant improvement in pain during intercourse associated with the realDN treatment ...

4.

ics.org

ics.org/2025/abstract/242

Dry needling to treat provoked vestibulodynia

Dry needling to treat provoked vestibulodynia: results of a feasibility and acceptability randomized controlled trial.

5.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05797480

NCT05797480 | Dry Needling for Provoked Vestibulodynia

Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain intensity and quality, pain ...

6.

clinicaltrials.gov

clinicaltrials.gov/study/NCT07534345

Efficacy of Dry Needling in Reducing Pain During Sexual ...

The proposed multicenter randomized controlled trial aims to establish the efficacy of DN for reducing pain in women with PVD. Women will be ...

7.

anesth-pain-med.org

anesth-pain-med.org/upload/pdf/Apm007-01-05.pdf

Successful treatment of vulvodynia with dry needling using ...

We report a case of vulvodynia successfully treated with dry needling using a specially designed needle. CASE REPORT. A 50-year-old woman visited interventional ...