Overview

This trial is active, not recruiting.

Conditions provoked, localized vulvodynia, provoked vestibulodynia, vulvar vestibulitis, vulvodynia
Treatments classical acupuncture, non-classical acupuncture, lidocaine
Phase phase 1
Sponsor Oregon College of Oriental Medicine
Collaborator National Vulvodynia Association
Start date November 2013
End date March 2016
Trial size 30 participants
Trial identifier NCT01996384, OHSU IRB 9664

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Study participants will attend 18 classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area based on up to three Traditional Chinese Medicine Diagnosis categories. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
classical acupuncture
Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are 0.18x30-40mm, manufactured by Dong Bae Corporation (DBC), Korea. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
lidocaine 5% Lidocaine cream
Study participants will gently apply 5% lidocaine cream four times daily to vulvar area.
(Active Comparator)
Study participants will attend 18 non-classical acupuncture sessions, twice a week for Weeks 1-6, and once a week for Weeks 7-12. A standardized acupuncture treatment will be assigned with non-classical acupuncture points and may or may not be stimulated with electroacupuncture. Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. Study participants will also be asked to gently apply 5% lidocaine cream four times daily (breakfast, lunch, dinner, and before bed).
non-classical acupuncture
Very thin needles (0.18mm) will be inserted into locations either on the front or the back of the body and may be placed near or far from the affected area. No needles will be inserted into the genital region. Locations needled will be in non-classical acupuncture points. On even-numbered visits, the needles may be electrically stimulated via an electro-acupuncture machine. Needles will be retained for 30 minutes per study visit. Acupuncture needles used are DBC Brand, Korea, 0.18x30-40mm. The electrical acupuncture device is Pantheon Research Electrical Stimulator 8c, United States.
lidocaine 5% Lidocaine cream
Study participants will gently apply 5% lidocaine cream four times daily to vulvar area.

Primary Outcomes

Measure
Tampon Test
time frame: Weeks 1 and 12 study period

Secondary Outcomes

Measure
Cotton Swab test
time frame: Weeks -4, -3, -2, -1, 0, 1, 12 or 13 and 24.
Patient Reported Outcomes Measurement Information System (PROMIS) Scales
time frame: At baseline visit, 6 weeks, 12 weeks, and 24 weeks
Satisfaction
time frame: Weeks 12 and 24
Expectation
time frame: Week 1
Feasibility
time frame: Weeks 12 and 24
Acceptability
time frame: Weeks 12 and 24
Tampon Test
time frame: Weeks 1 and 6; Weeks 1 and 24

Eligibility Criteria

Female participants from 18 years up to 45 years old.

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.

Additional Information

Official title Provoked, Localized Vulvodynia Treatment With Acupuncture and lidocaine-a Feasibility Pilot Study
Principal investigator Lee E Hullender Rubin, DAOM
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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2015.
Information provided to ClinicalTrials.gov by Oregon College of Oriental Medicine.