Study of Emu Oil vs. Placebo for Vulvar Pain in Women.

Study Overview
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Brief Summary
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The goal of this study is to determine if vulvar (external female genitalia) pain is decreased with emu oil over a similar placebo oil (no active ingredient) by using measurement devices, examinations, and questionnaires. Topical emu oil has not been scientifically studied for this condition yet, but related reports show no significant side effects or potential benefits. A total of 30 women will participate in the study at William Beaumont Hospital, Royal Oak.

Detailed Description
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Women of all ages with vulvar pain may participate in this trial. Women will be randomized into 2 groups--a treatment group or placebo group for the 1 month study. At the end of the study, those in the placebo group may choose to participate in a 1 month follow-up evaluation using emu oil.

Official Title
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The Efficacy of Emu Oil vs. Placebo in Minimizing Vulvar Pain Levels in Women--A Randomized, Double Blinded, Placebo-Controlled Trial.

Conditions
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Vulvodynia, Vestibulodynia

Intervention / Treatment
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* Other: Emu Oil
* Other: Inert oil


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Women with vulvar pain upon q-tip exam of > 3/10 at 2 or more sites tested. Age 18 or older. Capable of giving informed consent. Capable and willing to follow all study procedures. Exclusion Criteria: Pregnant women or those intending to become pregnant during the study period. Vaginitis (may be treated, then tested later). Vulvar disease (other than vulvodynia)-lichen planus, lichen sclerosis, neoplasia, tissue damage due to radiation. The subject is deemed unsuitable for enrollment by the investigators based on their history or physical examination. Neuropathy. Currently in pelvic floor physical therapy.

Ages Eligible for Study
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Minimum Age: 18 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: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Emu Oil<br> | Other: Emu Oil<br>* Subjects will apply a specified amount of emu oil daily to area.<br>|
| Placebo Comparator: inert oil<br> | Other: Inert oil<br>* A specified amount of inert oil will be applied daily to area.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in the Global Response Assessment (GRA) for vulvar pain. | Those moderately or markedly improved on the GRA are responders | After 1 month of intervention | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The change in vulvar pain levels | Based on a pain visual analog scale (VAS) and vulvalgesiometer evaluations. | After 1 month of intervention | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vulvar pain, Vulvodynia, Vestibulodynia, Vulvar vestibulitis