N/A
N=89
Effect of Acupuncture on Patient Vulvodynia Outcomes
Vulvodynia · Vulvodynia, Generalized · Vulvar Vestibulitis
Bottom Line
View on ClinicalTrials.gov: NCT03364127 ↗Enrolled (actual)
89
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Average Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS). — 3.90; 3.51; 2.48; 2.22 score on a scale — p=0.702
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Active Acupuncture (Other); Placebo Acupuncture (Other)
- Age
- Adult · 18+ yrs
- Sex
- Female
- Sponsor
- University of Illinois at Chicago
- Primary completion
- Oct 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS). |
3.90; 3.51; 2.48; 2.22 | 0.702 |
| SECONDARY Dyspareunia Subscale of the Female Sexual Function Index (FSFI) |
1.22; 1.38; 1.61; 1.83 | 0.77 |
| SECONDARY Total Score of the Female Sexual Function Index (FSFI) |
15.9; 17.4; 17.0; 19.3 | 0.436 |
| SECONDARY Vulvar Pain Intensity Will be Measured With the Pain Intensity Numbers Scale (PINS). |
4.19; 2.60; 3.37; 3.68; 3.79; 3.16 | 0.017 sig |
Summary
This study evaluates acupuncture for the treatment of vulvodynia; specifically if it reduces vulvar pain and pain with intercourse. It also examines how long the effect of acupuncture lasts in women with vulvodynia. Half of the women will receive acupuncture and the other half will receive placebo acupuncture. Women who get a reduction in pain will monitor there pain once a week for up to 12 weeks to see how long the acupuncture effect lasts.
Eligibility Criteria
Inclusion Criteria
- a previous diagnosis of generalized vulvodynia or provoked vestibulodynia
- 18 to 45 years old
- a pain now score 4 or higher with tampon insertion and removal performed at the initial screening exam
- speak and read English
Exclusionary Criteria
- infectious conditions of the vulva/vagina
- inflammatory conditions of the vulva/vagina
- neoplastic disorders of the vulva/vagina
- neurologic disorders of the vulva/vagina
- trauma to the genitals
- iatrogenic conditions of the genitals
- hormonal deficiencies
- co-morbid pelvic pain conditions (to avoid confounding pain outcomes) such as pelvic inflammatory disease and documented history of endometriosis
- menopause
Patients may have a history of but not have active in the last 6 months migraine headaches, temporomandibular joint disease (TMJ), irritable bowel syndrome (IBS), interstitial cystitis, painful bladder syndrome, or fibromyalgia.
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Data sourced from ClinicalTrials.gov (NCT03364127). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.