Vestibulodynia Clinical Trial
Official title:
Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief
Verified date | July 2015 |
Source | ProHealth Care, Inc |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
The objectives of this pilot study are to demonstrate effectiveness of application of the Erchonia Laser (manufactured by Erchonia Corporation),a non-invasive, non-significant risk low level laser red diode light therapy device, in providing relief of pain symptoms in patients with provoked and non- provoked vulvar vestibulitis; to reduce the frequency of use of oral medications to manage pain symptoms; and to reduce the debilitating affect vulvar vestibulitis has on the patient's daily activities, relationships and emotional well-being.
Status | Completed |
Enrollment | 10 |
Est. completion date | July 2015 |
Est. primary completion date | July 2015 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility |
Inclusion Criteria: - • Female - 18 years or older - Current diagnosis of provoked or non-provoked vulvar vestibulitis made by a suitably qualified medical professional - Vulvar pain is chronic, defined as having been present for at least 3 months. - Visual Analog Score for typical vulvar pain is at least 30/100 Patient has been stabilized on all hormonal interventions (i.e., birth control pills, topical or oral estrogen agents) and will not be altered for the course of the treatment protocol of this study. - Subject is willing and able to decrease use of current pain relief medication to manage vulvar pain throughout study participation, and is willing and able to refrain from engaging in other non-study treatments to manage her vulvar vestibulitis symptoms Exclusion Criteria: - • Vulvar dermatoses such as lichen sclerosis, squamous cell hyperplasia, or lichen planus - Active vaginal or pelvic infection, herpetic infections, vulvar cancer and/or treatment for cancer - Previous vestibulectomy or other surgical or procedural interventions (for vestibulitis ) to the treatment area - Active infection, wound or other external trauma to the areas to be treated with the laser - Other neurological disorders such as Multiple Sclerosis - Photosensitivity disorder - Pregnant or planning pregnancy prior to study end - Serious mental health illness, developmental disability or cognitive impairment that may preclude adequate comprehension of the consent form or ability to record study measures |
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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ProHealth Care, Inc |
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in the Vulvar Pain Functional Scale Questionnaire | Questionnaire involving specific functions that may impart pain in the vulvar region and patient response to present tolerance level. | Baseline, Week 6 and Week 8 | No |
Primary | Positive Change in Visual Analogue Pain Scale (VAS) with Q-tip testing over 6 visits | III. Q-tip testing: Position-Supine with pillows supporting each thigh in a semi-lithotomy supported position of comfort. A diagram of the vulva with sites numbered in a clock face arrangement will be presented to the patient for reference (shown in figure 1). The therapist will describe the Q-tip test that will be used to determine pain location and intensity (Zolnoun 2012). While the patient is viewing the picture, the therapist will use a warm, wet Q-tip to apply a light pressure at the numbered areas. Q-tip pressure will be applied at the following areas, in the exact order listed: 2:00, 10:00, 5:00, 7:00, 12:00, and 6:00 . The patient will be asked to rate their pain by marking an intensity point between 0-100 on the Visual Analogue Scale (VAS). A separate rating is recorded for each of the 6 numbered areas (see box 1 for reference). |
Compared from baseline visit, at 6th visit, and at 8 week follow up | No |
Secondary | Change in Patient Specific Functional Scale Questionnaire | Questionnaire that measures on a 0-10 scale one function that most impacts the patient's present symptoms. | Baseline, Week 6 and Week 8 | No |
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