Acupuncture for Vulvodynia: A Pre-pilot Study

Study Overview
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Brief Summary
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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.

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

Conditions
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Vulvodynia, Vulvar Vestibulitis, Dyspareunia, Pain

Intervention / Treatment
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* Other: Active Acupuncture
* Other: Placebo Acupuncture


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Active Acupuncture<br>Active Acupuncture 2 times per week for 5 weeks | Other: Active Acupuncture<br>* Active Acupuncture two times per week for 5 weeks<br>* Other names: Penetrating Acupuncture Needle;|
| Placebo Comparator: Placebo<br>Placebo Acupuncture 2 times per week for 5 weeks | Other: Placebo Acupuncture<br>* Placebo Acupuncture two times per week for 5 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Vulvar Pain Scale | PainReportIt, the computerized McGill Pain Questionnaire | baseline and twice weekly for 5 weeks | 
| Change in Dyspareunia Questionnaire | Female Sexual Function Index | baseline and once per week for 5 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Vulvar Function Status Questionnaire | Assesses vulvar function | at baseline and 5 weeks |