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Acupuncture for Vulvodynia: A Pre-pilot Study

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02704234
Recruitment Status : Completed
First Posted : March 9, 2016
Last Update Posted : June 14, 2017
Information provided by (Responsible Party):
Judith Schlaeger, University of Illinois at Chicago

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.

Condition or disease Intervention/treatment Phase
Vulvodynia Vulvar Vestibulitis Dyspareunia Pain Other: Active Acupuncture Other: Placebo Acupuncture Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 6 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Official Title: Acupuncture for Vulvodynia: A Double-blinded Feasibility Pre-pilot Study
Study Start Date : November 2015
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Acupuncture

Arm Intervention/treatment
Experimental: Active Acupuncture
Active Acupuncture 2 times per week for 5 weeks
Other: Active Acupuncture
Active Acupuncture two times per week for 5 weeks
Other Name: Penetrating Acupuncture Needle

Placebo Comparator: Placebo
Placebo Acupuncture 2 times per week for 5 weeks
Other: Placebo Acupuncture
Placebo Acupuncture two times per week for 5 weeks

Primary Outcome Measures :
  1. Change in Vulvar Pain Scale [ Time Frame: baseline and twice weekly for 5 weeks ]
    PainReportIt, the computerized McGill Pain Questionnaire

  2. Change in Dyspareunia Questionnaire [ Time Frame: baseline and once per week for 5 weeks ]
    Female Sexual Function Index

Secondary Outcome Measures :
  1. Vulvar Function Status Questionnaire [ Time Frame: at baseline and 5 weeks ]
    Assesses vulvar function

Other Outcome Measures:
  1. Sleep Quality Scale [ Time Frame: at baseline and 5 weeks ]
    Pittsburgh Sleep Quality Index

  2. The Protocol Acceptability Scale for Treating Vulvodynia with Acupuncture [ Time Frame: 5 weeks ]
    Acceptability of the acupuncture protocol for the participant

  3. Double-Blinded Needle Questionnaires for the Acupuncturist and for the Participant [ Time Frame: 5 weeks ]
    Assesses the Ability of the Acupuncturist and Subject to Remain Blind

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02704234

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United States, Illinois
A Center for Oriental Medicine
Wilmette, Illinois, United States, 60098
Sponsors and Collaborators
University of Illinois at Chicago
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Principal Investigator: judith schlaeger, PhD University of Illinois at Chicago
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Judith Schlaeger, Assistant Professor, University of Illinois at Chicago Identifier: NCT02704234    
Other Study ID Numbers: 2015-0692
First Posted: March 9, 2016    Key Record Dates
Last Update Posted: June 14, 2017
Last Verified: June 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female
Sexual Dysfunction, Physiological
Genital Diseases, Male
Sexual Dysfunctions, Psychological
Mental Disorders