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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02204319
Other study ID # IRB-13-21
Secondary ID
Status Completed
Phase N/A
First received March 24, 2014
Last updated July 1, 2015
Start date March 2014
Est. completion date July 2015

Study information

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

Clinical Trial Summary

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.


Description:

In the current proposed pilot study, application of a low level laser light device, manufactured by Erchonia Corporation, to reduce the pain of vulvar vestibulitis will be evaluated. The Erchonia Laser device will emit three independent 7 mW, 635 nm red light diodes in a hand-held device and is a variable frequency pulsed wave device.

Erchonia low level lasers have been determined safe and effective and non-significant risk (NSR) by the Food and Drug Administration (FDA) for application for numerous and various pain reduction indications, providing justification for the anticipated safety and effectiveness of application of the Erchonia Laser to reduce pain in patients with vulvar vestibulitis. The FDA has granted 510(k) clearances for Erchonia low level laser devices for five pain reduction indications, all cleared under Product Code 'NHN', defined as: "A light based non-laser device that emits energy in infrared or other wavelengths, provides non-heating and non-thermal effect, and is indicated for adjunctive use in pain therapy or related indication. It does not provide therapeutic topical heating."

The research will be conducted at ProHealth Care; Inc. across four campuses. Patients will be seen in private rooms in the therapy departments.

All study staff are licensed in the field of either Occupational Therapy or Physical therapy (2 in each) with the advanced continuing education necessary to call them a "specialist" in the treatment of pelvic floor disorders. All investigators will complete CITI training for research.

Subjects will be referred into the ProHealth Care system via a prescription for pelvic floor therapy signed by a licensed medical professional with the expertise to diagnose Vulvar vestibulitis. Written information regarding the study and proposed treatment will also be mailed to a larger group of pelvic floor therapists in the greater Milwaukee WI region through a "Pelvic Floor Study Group" list informing them of the need for subjects with this diagnosis so that they may inform their clients of the availability of such research. These clients may then request a referral from their private health care provider.

The pilot study will be completed in twelve months following the commitment of ProHealth Care, Inc. IRB as well as procurement of initial funding through grants applied for during 2013. There will be 10 patients enrolled in the pilot study.

Patients will be screened after they are referred by their physician for physical therapy.


Recruitment information / eligibility

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

Study Design

Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Device:
Cold laser
Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 mW, 635 nm red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
ProHealth Care, Inc

Outcome

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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