Clinical trial NCT05797480: Dry Needling for Provoked Vestibulodynia
Official title: Dry Needling for Women With Provoked Vestibulodynia: A Feasibility and Acceptability Randomized Controlled Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Provoked Vestibulodynia
Keywords: Dyspareunia
Vulvodynia
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
First posted: 2023-04-04
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Baseline evaluation - Randomization to real dry needling or sham dry needling (6 sessions for 6 consecutive weeks) - post-treatment evaluation (2-week post-treatment)
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Adherence to treatment sessions
timeFrame: Through treatment completion (session 1 to 6; 6 weeks of treatment)
measure: Adherence to treatment protocol
timeFrame: Through treatment completion (session 1 to 6; 6 weeks of treatment)
measure: Retention rate
timeFrame: Baseline to Post-treatment assessment (2-week post-treatment)
measure: Adverse effects
timeFrame: Through treatment completion (session 1 to 6; 6 weeks of treatment)
measure: Adverse effects
timeFrame: Post-treatment assessment (2-week post-treatment)
measure: Recruitment rate
timeFrame: Baseline
measure: Intervention Acceptability Questionnaire
timeFrame: Baseline
measure: Intervention Acceptability Questionnaire
timeFrame: After treatment session 3 (week 3)
measure: Intervention Acceptability Questionnaire
timeFrame: Post-treatment assessment (2-week post-treatment)
Secondary outcomes:
measure: Change in pain intensity during intercourse
timeFrame: Baseline to Post-treatment assessment (2-week post-treatment)
measure: Change in pain quality
timeFrame: Baseline to Post-treatment assessment (2-week post-treatment)
measure: Change in pain catastrophizing
timeFrame: Baseline to Post-treatment assessment (2-week post-treatment)
measure: Change in fear of pain
timeFrame: Baseline to Post-treatment assessment (2-week post-treatment)
measure: Change in sexual function
timeFrame: Baseline to Post-treatment assessment (2-week post-treatment)
measure: Change in sexual distress
timeFrame: Baseline to Post-treatment assessment (2-week post-treatment)
measure: Change in quality of life in the domains associated with chronic pelvic pain
timeFrame: Baseline to Post-treatment assessment (2-week post-treatment)
measure: Severity of symptoms related with central sensitization
timeFrame: Baseline to Post-treatment assessement (2-week post-treatment)
measure: Satisfaction with treatment
timeFrame: Post-treatment assessment (2-week post-treatment)
measure: Patient's global impression of change
timeFrame: Post-treatment assessment (2-week post-treatment)
measure: Blinding effectiveness
timeFrame: Post-treatment assessment (2-week post-treatment)
measure: Changes in pelvic floor muscle stiffness
timeFrame: Baseline to Post-treatment assessment (2-week post-treatment)
measure: Changes in pelvic floor muscle function
timeFrame: Baseline to Post-treatment assessment (2-week post-treatment)
measure: Changes in pain at palpation
timeFrame: Baseline to Post-treatment assessment (2-week post-treatment)
measure: Changes in pressure pain threshold
timeFrame: Baseline to Post-treatment assessment (2-week post-treatment)
Other outcomes:
Locations:
city: Sherbrooke
country: Canada
facility: Research Center of the Centre Hospitalier Universitaire de Sherbrooke
state: Quebec
Study officials:
affiliation: Université de Sherbrooke
name: Melanie Morin, PhD
role: PRINCIPAL_INVESTIGATOR
References: