Dry Needling for Provoked Vestibulodynia

February 4, 2025 updated by: Mélanie Morin, Université de Sherbrooke

Dry Needling for Women With Provoked Vestibulodynia: A Feasibility and Acceptability Randomized Controlled Study

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
46

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Canada
    • Quebec
      • Sherbrooke, Quebec, Canada, J1H5N4
        • Research Center of the Centre Hospitalier Universitaire de Sherbrooke

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 45 years (Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Experimental: Real Dry needling
1 dry needling treatment per week for 6 consecutive weeks
Other: Real Dry needling
Real dry needling will be applied to the pelvic floor, hip and lower back muscles.
Other Names:
  • Needling
Sham Comparator: Sham: Non penetrating dry needling
1 non penetrating dry needling per week for 6 consecutive weeks
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.
Other Names:
  • Control
  • Sham

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Adherence to treatment sessions
Time Frame: Through treatment completion (session 1 to 6; 6 weeks of treatment)
a. To determine feasibility, the patients' adherence to treatment sessions will be recorded (present vs absent) as well as reasons for non-attendance.
Through treatment completion (session 1 to 6; 6 weeks of treatment)
Retention rate
Time Frame: Baseline to Post-treatment assessment (2-week post-treatment)
a. To determine feasibility by assessing the percentage of participants completing the post-treatment assessment. Reason for dropouts will be compiled
Baseline to Post-treatment assessment (2-week post-treatment)
Recruitment rate
Time Frame: Baseline
a. To determine feasibility by assessing the percentage of participants included versus the participants screened. The barriers and reasons for refusing to participate as well as the reasons for exclusion will be documented
Baseline
Adherence to treatment protocol
Time Frame: Through treatment completion (session 1 to 6; 6 weeks of treatment)
a. To determine feasibility by assessing adherence to treatment sessions.
Through treatment completion (session 1 to 6; 6 weeks of treatment)
Adverse effects
Time Frame: Through treatment completion (session 1 to 6; 6 weeks of treatment)
a. Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.
Through treatment completion (session 1 to 6; 6 weeks of treatment)
Adverse effects
Time Frame: Post-treatment assessment (2-week post-treatment)
a. Adverse effects observed and reported will be documented at each treatment session and at the post-treatment assessment.
Post-treatment assessment (2-week post-treatment)
Intervention Acceptability Questionnaire
Time Frame: Baseline
a. The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
Baseline
Intervention Acceptability Questionnaire
Time Frame: After treatment session 3 (week 3)
a. The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
After treatment session 3 (week 3)
Intervention Acceptability Questionnaire
Time Frame: Post-treatment assessment (2-week post-treatment)
a. The Intervention Acceptability Questionnaire will be used to assess the participants' acceptability of the interventions. This questionnaire consists of 6 items measured on a VAS scale (Minimum value: 0; Maximum Value: 10). Each item is analyzed separately, with a greater score meaning higher acceptability of the intervention.
Post-treatment assessment (2-week post-treatment)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change in pain intensity during intercourse
Time Frame: Baseline to Post-treatment assessment (2-week post-treatment)
To explore changes in pain intensity during intercourse (Numerical Rating Scale (NRS)). Ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever.
Baseline to Post-treatment assessment (2-week post-treatment)
Change in pain quality
Time Frame: Baseline to Post-treatment assessment (2-week post-treatment)
To explore changes on the sensory, affective, and evaluative components of pain (McGill-Melzack Questionnaire). Ranging from 0 to 78, higher scores mean worst outcome (higher pain).
Baseline to Post-treatment assessment (2-week post-treatment)
Change in pain catastrophizing
Time Frame: Baseline to Post-treatment assessment (2-week post-treatment)
To explore changes on pain catastrophizing (Pain catastrophizing scale (PCS)). Ranging from 0 to 52, higher scores mean worse outcome (higher pain catastrophizing).
Baseline to Post-treatment assessment (2-week post-treatment)
Change in fear of pain
Time Frame: Baseline to Post-treatment assessment (2-week post-treatment)
To explore changes in fear of pain (Pain anxiety Symptoms Scale (PASS-20). Ranging from 0 to 100, higher scores mean worse outcome (higher fear of pain).
Baseline to Post-treatment assessment (2-week post-treatment)
Change in sexual function
Time Frame: Baseline to Post-treatment assessment (2-week post-treatment)
To explore changes in sexual function (Female Sexual Function Index - FSFI). Ranging from 2 to 36, lower scores mean wort outcome (low sexual function).
Baseline to Post-treatment assessment (2-week post-treatment)
Change in sexual distress
Time Frame: Baseline to Post-treatment assessment (2-week post-treatment)
To explore changes in sexual distress (Female Sexual Distress Scale - FSDS). Ranging from 0 to 52, higher scores mean worse outcome (higher sexually related distress).
Baseline to Post-treatment assessment (2-week post-treatment)
Change in quality of life in the domains associated with chronic pelvic pain
Time Frame: Baseline to Post-treatment assessment (2-week post-treatment)
To explore changes in quality of life Pelvic Pain Impact Questionnaire (PPIQ). Ranging from 0 to 32, higher scores mean worse outcome (less quality of life associated with pelvic pain).
Baseline to Post-treatment assessment (2-week post-treatment)
Severity of symptoms related with central sensitization
Time Frame: Baseline to Post-treatment assessement (2-week post-treatment)
To explore changes in symptoms related to central sensitization (Central Sensitization Inventory). Ranging from 0 to 100, a higher scores indicates higher central sensitivity.
Baseline to Post-treatment assessement (2-week post-treatment)
Satisfaction with treatment
Time Frame: Post-treatment assessment (2-week post-treatment)
To determine acceptability by measuring the participants' satisfaction with the treatment on a Numeric Rating Scale (NRS) ranging from 0 (completely dissatisfied) to 10 (complete satisfied).
Post-treatment assessment (2-week post-treatment)
Patient's global impression of change
Time Frame: Post-treatment assessment (2-week post-treatment)
To examine patient self-reported improvement (Patient's Global Impression of Change). Ranging from "very much worse" to "very much improved" on a 7-point scale.
Post-treatment assessment (2-week post-treatment)
Changes in pelvic floor muscle stiffness
Time Frame: Baseline to Post-treatment assessment (2-week post-treatment)
To explore changes in pelvic floor muscle stiffness (Shearwave elastography)
Baseline to Post-treatment assessment (2-week post-treatment)
Changes in pelvic floor muscle function
Time Frame: Baseline to Post-treatment assessment (2-week post-treatment)
To explore changes in pelvic floor muscle function (Dynamometric speculum)
Baseline to Post-treatment assessment (2-week post-treatment)
Changes in pain at palpation
Time Frame: Baseline to Post-treatment assessment (2-week post-treatment)
To explore changes at intravaginal palpation of the internal obturators and the levator ani muscles following a standardized procedure (Numerical Rating Scale). Ranging from 0 to 10, where 0 is no pain at all, and 10 is the worst pain ever.
Baseline to Post-treatment assessment (2-week post-treatment)
Changes in pressure pain threshold
Time Frame: Baseline to Post-treatment assessment (2-week post-treatment)
To explore changes in pressure pain threshold if predetermined areas of the pelvis (Wagner algometer)
Baseline to Post-treatment assessment (2-week post-treatment)
Blinding effectiveness
Time Frame: Post-treatment assessment (2-week post-treatment)
To assess the feasibility of maintaining blinding to group allocation for the participants. Evaluated by asking the question: ''What treatment do you think you have received? ''
Post-treatment assessment (2-week post-treatment)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Université de Sherbrooke

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Nathaly Gaudreault
Josiane Paré
Nathalie J. Bureau
Mélanie Roch

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Melanie Morin, PhD, Université de Sherbrooke

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 27, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 17, 2024

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 17, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 27, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 21, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 4, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 25, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 4, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 2023-4686

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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