Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study
CompletedPhase 1NCT01996384
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
The investigators research project is a randomized, controlled, single-blinded, feasibility pilot study. The investigators will study the feasibility of a novel treatment for women with Provoked Localized Vulvodynia (PLV) with acupuncture and 5% lidocaine cream. Lidocaine is a numbing agent and common first treatment for this disorder. Acupuncture is a treatment commonly used for other pain disorders. The investigators will compare two types of acupuncture (classical and non-classical) as a treatment for PLV, in addition to 5% lidocaine cream. Researchers want to determine if acupuncture is acceptable and convenient to women with PLV. The investigators hypothesize that classical acupuncture and 5% lidocaine cream will be better than non-classical acupuncture and 5% lidocaine cream to decrease PLV pain.
Study details
- Official title
- Acupuncture Augmentation of Lidocaine for the Treatment of Provoked, Localized vulvodynia-a Feasibility and Acceptability Pilot Study
- Conditions
- Provoked, Localized Vulvodynia
- Provoked Vestibulodynia
- Vulvar Vestibulitis
- Vulvodynia
- Interventions
- Procedure: Classical Acupuncture
- Procedure: Non-classical acupuncture
- Drug: Lidocaine
- Sponsor
- Oregon College of Oriental Medicine
- Collaborators
- National Vulvodynia Association; Council of Colleges of Acupuncture and Oriental Medicine; Oregon Health and Science University
- Start date
- 2013-11
- Primary completion
- 2016-03
- Sex
- Female
- Age range
- from 18 Years to 45 Years
- Results posted
- No results posted in this snapshot
- Countries
- United States
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Literate, English speaking, premenopausal, women meeting Friedrich's criteria for Provoked, localized vulvodynia * Reported introital dyspareunia longer than three months duration; * Average pain score greater than 4 on Visual Analog Scale (VAS) at enrollment with cotton swab test and Tampon Test; * Able to insert an Original Regular Tampax™ tampon. Exclusion Criteria: * Co-existing conditions leading to dyspareunia including generalized unprovoked vulvodynia, atrophic vaginitis, vulvovaginal dermatoses (e.g. lichen sclerosus), or genital infection (e.g. herpes simplex virus or yeast infection). * Pregnant or postpartum and breastfeeding; * Use of neuromodulator medications (e.g. Serotonin Norepinephrine Reuptake Inhibitors (SNRIs), Tricyclic Antidepressants, or anti-seizure medications) started in the last six months. If taken for longer, must be on a stable dose for at least six months and still report moderate to severe pain. Selective Serotonin Reuptake Inhibitors (SSRIs) are allowed; * Postmenopausal as defined by surgical or natural menopause (no menses for 12 months); * Chronic pelvic pain defined as daily, non-menstrual pain in pelvis or lower abdomen for longer than three months duration; * Must be able to refrain from other treatments for PLV including non-traditional options (e.g. other medications, physical therapy, sex therapy, acupuncture, naturopathic remedies) during the course of the study (6 months). * Use of SNRIs, lidocaine, or acupuncture within the last three months.
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT01996384