Provoked, Localized Vulvodynia Treatment With Acupuncture and Lidocaine Pilot Study

Brief Title

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

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.
    

Study Phase

Phase 1

Study Type

Interventional


Primary Outcome

Tampon Test

Secondary Outcome

 Cotton Swab test

Condition

Provoked, Localized Vulvodynia

Intervention

Classical Acupuncture

Study Arms / Comparison Groups

 Classical Acupuncture + Lidocaine
Description:  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).

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Procedure

Estimated Enrollment

19

Start Date

November 2013

Completion Date

March 2016

Primary Completion Date

March 2016

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.
      

Gender

Female

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

Lee E Hullender Rubin, DAOM, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT01996384

Organization ID

OHSU IRB 9664


Responsible Party

Principal Investigator

Study Sponsor

Oregon College of Oriental Medicine

Collaborators

 National Vulvodynia Association

Study Sponsor

Lee E Hullender Rubin, DAOM, Principal Investigator, Oregon College of Oriental Medicine


Verification Date

October 2017