Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief

Brief Title

Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief

Official Title

Cold Laser: A Modality to Promote Vulvar Healing and Pain Relief

Brief 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.
    

Detailed 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 milliWatt, 635 nanometer
      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 Wisconsin 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. Institutional Review Board 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.
    


Study Type

Interventional


Primary Outcome

Percent Improvement Change in Visual Analogue Pain Scale (VAS) Calculated With Q-tip Palpation Over 6 Sites From Baseline Visit to Follow up at Two Week From Last Visit

Secondary Outcome

 Change in Patient Specific Functional Scale Questionnaire

Condition

Vulvar Vestibulitis

Intervention

Cold laser

Study Arms / Comparison Groups

 Cold Laser Treatment
Description:  Cold laser used off of the body over the vulvar involved area. The device to be used in this study is the Erchonia Corporation variable frequency pulsed wave low level laser device employing three independent 7 milliWatt, 635 nanometer red light diodes mounted in a hand-held device and is a variable frequency pulsed wave device. Weekly visits x 6 with 5 minute treatments over vulva and sacral nerve roots each.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Device

Estimated Enrollment

10

Start Date

March 2014

Completion Date

July 2015

Primary Completion Date

July 2015

Eligibility Criteria

        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
      

Gender

Female

Ages

18 Years - N/A

Accepts Healthy Volunteers

No

Contacts

Linda A LaBorde, BS PT, , 



Administrative Informations


NCT ID

NCT02204319

Organization ID

IRB-13-21


Responsible Party

Sponsor

Study Sponsor

ProHealth Care, Inc


Study Sponsor

Linda A LaBorde, BS PT, Principal Investigator, ProHealth Care, Inc


Verification Date

April 2017