Efficacy of Dry Needling in Reducing Pain During Sexual Intercourse

Summary

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.

Conditions

• Provoked Vestibulodynia

Interventions

OTHER

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

Sham dry needling

The same treatment regimen will be applied using sham, non-penetrating, needles.

Sponsors & Collaborators

• Centre de recherche du Centre hospitalier universitaire de Sherbrooke

  collaborator OTHER

• Cigonia

  collaborator UNKNOWN

• CHU de Quebec-Universite Laval

  collaborator OTHER

• Kinatex l'Ormière

  collaborator UNKNOWN

• Université de Sherbrooke

  lead OTHER

Principal Investigators

• Mélanie Morin · Université de Sherbrooke

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

TRIPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

45 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2026-05-11

Primary Completion

2029-06-30

Completion

2029-06-30

Countries

• Canada

Study Locations