Clinical trial NCT01996384: Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study
Official title: Acupuncture Augmentation of Lidocaine for the Treatment of Provoked, Localized vulvodynia-a Feasibility and Acceptability Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Provoked, Localized Vulvodynia
Provoked Vestibulodynia
Vulvar Vestibulitis
Vulvodynia
Keywords: Vulvodynia
Provoked, localized vulvodynia
vulvar vestibulitis
provoked vestibulodynia
vulvovaginal pain
vulvar pain
vaginal pain
chronic pain
lidocaine
numbing agent
anesthetic cream
acupuncture
electroacupuncture
electrical stimulated acupuncture
manual acupuncture
classical acupuncture
non-classical acupuncture
Traditional Chinese Medicine
TCM
Chinese medicine
Acupuncture and Oriental Medicine
AOM
treatment
feasibility
pilot study
Patient Reported Outcomes Measure Information System
Tampon Test
cotton swab test
pain diary
Research Electronic Data Capture
REDCap
Lead sponsor: Oregon College of Oriental Medicine
Sponsor class: OTHER
Collaborators: name: National Vulvodynia Association
name: Council of Colleges of Acupuncture and Oriental Medicine
name: Oregon Health and Science University
First posted: 2013-11-27
Enrollment: 19
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: This is a randomized, controlled, single-blinded, pilot trial to study the feasibility and acceptability of acupuncture and 5% lidocaine. Patients will be recruited from the patient population of the Oregon Health \& Science University Vulvar Health Clinic. Thirty (30) patients with PLV will be enrolled as study participants into the study. Fifteen (15) will be allocated in the treatment (classical) acupuncture + 5% lidocaine group and fifteen (15) will be allocated in the control (non-classical) acupuncture + 5% lidocaine group via a computer generated randomization program to balance allocation based on four variables: pain intensity, smoking status, body mass index, and pain duration.

The acupuncturist will interview each patient and perform an exam of the pulse and tongue. A standardized acupuncture treatment will be assigned, and both groups will receive 18 acupuncture treatments that follow a standardized protocol on classical or non-classical acupuncture points, with or without mild electrical stimulation. All study participants will self-apply lidocaine cream to their genital region four times daily during the study.

Eligibility criteria: 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.

Primary outcomes:
measure: Tampon Test
timeFrame: Weeks 1 and 12 study period
Secondary outcomes:
measure: Cotton Swab test
timeFrame: Weeks -4, -3, -2, -1, 0, 1, 12 or 13 and 24.
measure: Patient Reported Outcomes Measurement Information System (PROMIS) Scales
timeFrame: At baseline visit, 6 weeks, 12 weeks, and 24 weeks
measure: Satisfaction
timeFrame: Weeks 12 and 24
measure: Expectation
timeFrame: Week 1
measure: Feasibility
timeFrame: Weeks 12 and 24
measure: Acceptability
timeFrame: Weeks 12 and 24
measure: Tampon Test
timeFrame: Weeks 1 and 6; Weeks 1 and 24
Other outcomes:
measure: Traditional Chinese Medicine (TCM) Diagnosis Category
timeFrame: Week 1
measure: 24-hour mean pain score
timeFrame: Baseline, Weeks 6, 12, and 24
measure: Frequency of intercourse
timeFrame: Baseline, Weeks 6, 12, and 24
measure: Intensity of Intercourse pain
timeFrame: Baseline, Weeks 6, 12, and 24
Locations:
city: Portland
country: United States
facility: Women's Health Research Unit; Oregon Health & Science University
state: Oregon
Study officials:
affiliation: Oregon College of Oriental Medicine
name: Lee E Hullender Rubin, DAOM
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hullender Rubin LE, Mist SD, Schnyer RN, Chao MT, Leclair CM. Acupuncture Augmentation of Lidocaine for Provoked, Localized Vulvodynia: A Feasibility and Acceptability Study. J Low Genit Tract Dis. 2019 Oct;23(4):279-286. doi: 10.1097/LGT.0000000000000489.