Dry Needling for Provoked Vestibulodynia

NCT ID: NCT05797480

Last Updated: 2025-02-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-02-27
• Study Completion Date: 2024-07-17

Brief Summary

This is a randomized and controlled study investigating the feasibility and acceptability of a dry needling treatment for women suffering from provoked vestibulodynia. Following their enrollment in the study, participants will undergo a gynecological examination for confirmation of their diagnoses of provoked vestibulodynia. Women diagnosed with provoked vestibulodynia will be randomized into the dry needling group or the sham-needle group. The dry needling group will receive 6 sessions of real dry needling for 6 consecutive weeks. The sham group will receive 6 sessions of sham needling for 6 consecutive weeks, using a validated sham-needle. Outcomes measures will be assessed at baseline and at post-treatment and will include: feasibility and acceptability variables, pain intensity and quality, pain during palpation and pressure pain threshold, psychosexual variables, perceived improvement and satisfaction after the treatment as well as pelvic floor muscle stiffness and function.

Detailed Description

Up to 18% of reproductive-aged women experience chronic pain in the vulvar region during sexual intercourse. This chronic pain condition is called vulvodynia. The main subtype of this pain condition is provoked vestibulodynia (PVD), which is characterized by a sharp or burning pain at the vaginal opening when there is a pressure applied to the vulvar vestibule or attempting vaginal penetration. Women suffering from PVD suffer from sexual dysfunctions, psychological distress and worsened quality of life. The treatment options currently available are still quite limited and some women still experience pain despite undertaking all options available. We, therefore, proposed a randomized and controlled study to investigate the feasibility and acceptability of a dry needling treatment for women suffering from PVD. Women diagnosed with provoked vestibulodynia will be randomized into the dry needling group or the sham-needle group. Participants and evaluators will be blinded. The dry needling group will receive 6 sessions of real dry needling for 6 consecutive weeks. For the first three sessions, the dry needling/or sham techniques will be aimed at the muscles of the trunk, lower back, hips and SI joints. For the last 3 treatment sessions, the dry needling/or sham techniques will aimed at the pelvic floor muscles. The sham group will receive the same 6 sessions of sham needling for 6 consecutive weeks, using a validated sham-needle. Outcomes measures will be assessed at baseline and 2 weeks post-treatment and will include: feasibility (adherence to treatment, retention rates, adverse effects, recruitment rates and data on dry needling (needles, # of insertions, pain related) and acceptability variables. Secondary outcomes will include pain intensity during intercourse (numeric scale) and quality (McGill pain questionnaire), pain during palpation and pressure pain threshold (Pressure algometer), psychosexual variables (sexual distress and sexual function), change in pain catastrophizing, change in quality of life in domains associated with chronic pelvic pain (Pelvic Pain Impact questionnaire, severity of symptoms related to central sensitization), perceived improvement and satisfaction after the treatment as well as pelvic floor muscle stiffness (shearwave elastography and dynamometric speculum)and function (dynamometric speculum), blinding efficacy.

Conditions

Provoked Vestibulodynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Experimental: Real Dry needling

1 dry needling treatment per week for 6 consecutive weeks

Group Type: EXPERIMENTAL

Real Dry needling

Intervention Type: OTHER

Real dry needling will be applied to the pelvic floor, hip and lower back muscles.

Sham: Non penetrating dry needling

1 non penetrating dry needling per week for 6 consecutive weeks

Group Type: SHAM_COMPARATOR

Non penetrating dry needling

Intervention Type: OTHER

Sham non penetrating dry needling (fixed needle in an introducer tube) will be applied to the pelvic floor, hip and lower back muscles.

Interventions

Real Dry needling

Real dry needling will be applied to the pelvic floor, hip and lower back muscles.

Intervention Type: OTHER

Non penetrating dry needling

Sham non penetrating dry needling (fixed needle in an introducer tube) will be applied to the pelvic floor, hip and lower back muscles.

Intervention Type: OTHER

Other Intervention Names

Needling; Sham; Control

Eligibility Criteria

Inclusion Criteria

• Diagnosis of provoked vestibulodynia according to a standardised gynaecologic exam
• Moderate to severe pain (≥ 5/10) in at least 90% of sexual intercourses or attempted sexual intercourse for at least 3 months

Exclusion Criteria

• Other causes of vulvo-vaginal pain (e.g., spontaneous vulvovaginal pain not related to sexual intercourse/contact, dermatological condition, herpes, vulvo-vaginal atrophy)
• Post-menopausal state
• Actual or past pregnancy in the last year
• Urogynecological conditions (e.g., pelvic organs prolapse (POP) ≥ 3, urinary/vaginal infection active or in the last 3 months)
• Previous vulvar, vaginal or pelvic surgery (e.g., vestibulectomy, corrective pelvic organs prolapse surgery)
• Prior use of dry needling or acupuncture treatments
• Fear of needles or any contraindication to needling therapies
• Changes of medication that could influence pain perception (e.g., analgesic, antidepressant) in the last 3 months
• Other medical conditions that could interfere with the study

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 45 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Université de Sherbrooke

OTHER

Sponsor Role: lead

Responsible Party

Mélanie Morin

Principal investigator, professor and researcher, director of the research laboratory in urogynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Melanie Morin, PhD

Role: PRINCIPAL_INVESTIGATOR

Université de Sherbrooke

Locations

Research Center of the Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, Canada

Countries

Canada

Other Identifiers

2023-4686

Identifier Type: -

Identifier Source: org_study_id