Acupuncture for Vulvodynia: A Pre-pilot Study

Brief Title

Acupuncture for Vulvodynia: A Pre-pilot Study

Official Title

Acupuncture for Vulvodynia: A Double-blinded Feasibility Pre-pilot Study

Brief Summary

      Vulvodynia is a women's pain condition. Women have pain in their vulva, the area in their
      genitals between the vagina and labia (lips of the vagina). They also have pain when they
      have sexual intercourse or insert anything in the vagina. Sometimes they have so much pain,
      that they cannot have sex.

      This research is being done for two reasons. The first reason is to test a set of special
      needles called double-blinded acupuncture needles to give acupuncture treatments (one is a
      real needle and the other is a fake needle). The second reason is to develop a protocol
      (checklist) that will be used in this and future studies, and to identify and resolve any
      procedural problems. The protocol will be first tested by the principal investigator who is
      also an acupuncturist. The investigator will perform acupuncture using the protocol, if
      necessary change the protocol, and then teach a second acupuncturist using the modified
      protocol how to use the double-blinded acupuncture needles.

      The real needle called the penetrating needle penetrates the skin. The fake needle called the
      non-penetrating placebo touch needle does not penetrate the skin but it touches the skin so
      it feels like a needle is being inserted. It has a blunt tip.

      Participants can't see which needle they are getting acupuncture with because the needles are
      housed in a double-blinded needle device which has two tubes (an inner and an outer) that
      neither the acupuncturists nor the participants can see through.

      If a fake acupuncture needle can be used in acupuncture research like a sugar pill is used
      for drug studies to see how well the real medicine works, the investigators can see how
      effective acupuncture is. The investigators will be testing these needles to treat
      participants with vulvodynia.
    



Study Type

Interventional


Primary Outcome

Change in Vulvar Pain Scale

Secondary Outcome

 Vulvar Function Status Questionnaire

Condition

Vulvodynia

Intervention

Active Acupuncture

Study Arms / Comparison Groups

 Active Acupuncture
Description:  Active Acupuncture 2 times per week for 5 weeks

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

Other

Estimated Enrollment

6

Start Date

November 2015

Completion Date

May 2016

Primary Completion Date

May 2016

Eligibility Criteria

        Inclusion Criteria:

          -  women previously diagnosed with generalized vulvodynia

          -  women previously diagnosed with localized vestibulodynia,

        Exclusion Criteria:

          -  pregnancy

          -  menopause

          -  interstitial cystitis

          -  irritable bowel syndrome

          -  untreated vaginitis

          -  cervicitis

          -  pelvic inflammatory disease

          -  any other pelvic pathology causing pain

          -  concomitant physical therapy

          -  concomitant biofeedback

          -  concomitant massage

          -  additional acupuncture
      

Gender

Female

Ages

18 Years - 45 Years

Accepts Healthy Volunteers

No

Contacts

judith schlaeger, PhD, , 

Location Countries

United States

Location Countries

United States

Administrative Informations


NCT ID

NCT02704234

Organization ID

2015-0692


Responsible Party

Principal Investigator

Study Sponsor

University of Illinois at Chicago


Study Sponsor

judith schlaeger, PhD, Principal Investigator, University of Illinois at Chicago


Verification Date

June 2017