Dry Needling for Provoked Vestibulodynia

NCT05797480 | Completed

• 1 other identifier: 2023-4686
• Study Type: interventional
• Target: 46
• Locations: 1 country
• Sites: 1

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.

Conditions

Provoked Vestibulodynia

Keywords

Dyspareunia; Vulvodynia

Outcome Measures

Primary Outcomes (9)

• Adherence to treatment sessions

  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)

• Adherence to treatment protocol

  a. To determine feasibility by assessing adherence to treatment sessions.

  Through treatment completion (session 1 to 6; 6 weeks of treatment)

• Retention rate

  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)

• Adverse effects

  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

  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)

• Recruitment rate

  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

• Intervention Acceptability Questionnaire

  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

  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

  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 Outcomes (15)

• Change in pain intensity during intercourse

  Baseline to Post-treatment assessment (2-week post-treatment)

• Change in pain quality

  Baseline to Post-treatment assessment (2-week post-treatment)

• Change in pain catastrophizing

  Baseline to Post-treatment assessment (2-week post-treatment)

• Change in fear of pain

  Baseline to Post-treatment assessment (2-week post-treatment)

• Change in sexual function

  Baseline to Post-treatment assessment (2-week post-treatment)

Study Arms (2)

Experimental: Real Dry needling

EXPERIMENTAL

1 dry needling treatment per week for 6 consecutive weeks

Other: Real Dry needling

Sham: Non penetrating dry needling

SHAM COMPARATOR

1 non penetrating dry needling per week for 6 consecutive weeks

Other: Non penetrating dry needling

Interventions

Real Dry needling OTHER

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

Also known as: Needling

Experimental: Real Dry needling

Non penetrating dry needling OTHER

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

Also known as: Sham, Control

Sham: Non penetrating dry needling

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Université de Sherbrooke: lead

Study Sites (1)

Research Center of the Centre Hospitalier Universitaire de Sherbrooke

Sherbrooke, Quebec, J1H5N4, Canada

Location

MeSH Terms

Conditions

Dyspareunia; Vulvodynia

Interventions

salicylhydroxamic acid

Condition Hierarchy (Ancestors)

Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Sexual Dysfunction, Physiological; Male Urogenital Diseases; Sexual Dysfunctions, Psychological; Mental Disorders; Vulvar Diseases

Study Officials

• Melanie Morin, PhD

  Université de Sherbrooke

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator, professor and researcher, director of the research laboratory in urogynecology

Model Details: Baseline evaluation - Randomization to real dry needling or sham dry needling (6 sessions for 6 consecutive weeks) - post-treatment evaluation (2-week post-treatment)

Study Record Dates

• First Submitted: February 27, 2023
• First Posted: April 4, 2023
• Study Start: February 27, 2023
• Primary Completion: July 17, 2024
• Study Completion: July 17, 2024
• Last Updated: February 7, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)