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.
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Adherence to treatment sessions
Timeframe: Through treatment completion (session 1 to 6; 6 weeks of treatment)
Adherence to treatment protocol
Timeframe: Through treatment completion (session 1 to 6; 6 weeks of treatment)
Retention rate
Timeframe: Baseline to Post-treatment assessment (2-week post-treatment)
Adverse effects
Timeframe: Through treatment completion (session 1 to 6; 6 weeks of treatment)
Adverse effects
Timeframe: Post-treatment assessment (2-week post-treatment)
Recruitment rate
Timeframe: Baseline
Intervention Acceptability Questionnaire
Timeframe: Baseline
Intervention Acceptability Questionnaire
Timeframe: After treatment session 3 (week 3)
Intervention Acceptability Questionnaire
Timeframe: Post-treatment assessment (2-week post-treatment)