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Dry Needling for Provoked Vestibulodynia

N/A

Recruiting

Led By Melanie Morin, PhD

Research Sponsored by Université de Sherbrooke

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through treatment completion (session 1 to 6; 6 weeks of treatment)

Awards & highlights

Study Summary

This trial studies the effects of dry needling to treat pelvic pain in women with provoked vestibulodynia. Participants randomized to receive real or sham needle therapy over 6 weeks, with outcomes measured.

Who is the study for?

This trial is for women with provoked vestibulodynia, experiencing moderate to severe pain during most sexual activities for at least three months. Participants should not be pregnant or have had vulvar surgery, other causes of vulvo-vaginal pain, post-menopausal state, fear of needles, or used dry needling/acupuncture before.Check my eligibility

What is being tested?

The study tests the effectiveness of real versus sham (fake) dry needling in treating provoked vestibulodynia. Women will be randomly assigned to receive either 6 sessions of actual dry needling or sham needling over six weeks and evaluated on pain relief and psychosexual factors.See study design

What are the potential side effects?

Potential side effects from dry needling may include temporary soreness at the needle site, minor bleeding or bruising. The sham procedure carries minimal risk since it does not penetrate the skin.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Adherence to treatment protocol

Adherence to treatment sessions

Adverse effects

+3 more

Secondary outcome measures

Blinding effectiveness

Change in fear of pain

Change in pain catastrophizing

+12 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental: Real Dry needlingExperimental Treatment1 Intervention

1 dry needling treatment per week for 6 consecutive weeks

Group II: Sham: Non penetrating dry needlingPlacebo Group1 Intervention

1 non penetrating dry needling per week for 6 consecutive weeks

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

Josiane ParéUNKNOWN

Nathaly GaudreaultUNKNOWN

Nathalie J. BureauUNKNOWN

Media Library

Dry needling (Other) Clinical Trial Eligibility Overview. Trial Name: NCT05797480 — N/A

Provoked Vestibulodynia Research Study Groups: Experimental: Real Dry needling, Sham: Non penetrating dry needling

Provoked Vestibulodynia Clinical Trial 2023: Dry needling Highlights & Side Effects. Trial Name: NCT05797480 — N/A

Dry needling (Other) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05797480 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is eligibility for this test restricted to individuals below a certain age threshold?

"According to this research project's requirements, the minimum age of participation is 18 and the maximum age ceiling is 45."

Answered by AI

Am I qualified to join this research project?

"In order to meet the requirements of this clinical trial, patients need to have a history of provoked vestibulodynia and fall between 18-45 years old. Currently, researchers are seeking 46 volunteers for participation."

Answered by AI

Are there still opportunities to partake in this clinical experiment?

"Affirmative, according to the records published on clinicaltrials.gov this trial is still recruiting patients. It was initially announced on March 30th 2023 and modified for the last time on March 21st of that same year. There are 46 participants needed from 1 medical centre."

Answered by AI

What is the uppermost limit of participants in this trial?

"Affirmative. According to the information made available on clinicaltrials.gov, this trial is still open for enrollment and was first published on March 30th 2023 with its last edit being made 21 days later. At present, 46 participants are needed from just one medical site."

Answered by AI

What is the main goal of this clinical experiment?

"The primary aim of this 6-week trial is to determine the retention rate. Secondary objectives involve gauging changes in central sensitization (Central Sensitisation Inventory, 0 - 100), pain quality (McGill-Melzack Questionnaire, 0 - 78) and catastrophizing levels (Pain Catastrophising Scale, 0 - 52)."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dry Needling for Provoked Vestibulodynia

Mélanie Morin 2023. "Dry Needling for Provoked Vestibulodynia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05797480.

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