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

Status: Completed
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 45
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Canada
Research Center of the Centre Hospitalier Universitaire de Sherbrooke
Sherbrooke
Time Frame
Start Date: 2023-02-27
Completion Date: 2024-07-17
Participants
Target number of participants: 46
Treatments
Experimental: Experimental: Real Dry needling
1 dry needling treatment per week for 6 consecutive weeks
Sham_comparator: Sham: Non penetrating dry needling
1 non penetrating dry needling per week for 6 consecutive weeks
Related Therapeutic Areas
Sponsors
Leads: Université de Sherbrooke

This content was sourced from clinicaltrials.gov