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

NCT02204319 | Terminated Results

• 1 other identifier: IRB-13-21
• Study Type: interventional
• Target: 10
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Vulvar Vestibulitis; Vestibulodynia

Keywords

provoked or non-provoked vulvar vestibulitis; low level laser light device

Outcome Measures

Primary Outcomes (1)

• 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

  III. Q-tip testing: . 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. An average VAS report of pain taken overall and compared from first baseline visit to end of study re-assessment two weeks following last treatment. • Pain intensity marked an a line with a 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). 100 is maximum pain level and 0 is no pain measured in centimeters per FDA guidelines for pain calculation on the VAS

  Average of all sites Compared from baseline visit and at 8 week (from start) follow up

Secondary Outcomes (1)

• Change in Patient Specific Functional Scale Questionnaire

  Baseline, and two weeks following last treatment at Week 8

Other Outcomes (1)

• Change in the Vulvar Pain Functional Scale Questionnaire

  Baseline, and after last treatment visit at Week 8

Study Arms (1)

Cold Laser Treatment

EXPERIMENTAL

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.

Device: Cold laser

Interventions

Cold laser DEVICE

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.

Also known as: The Erchonia Laser device

Cold Laser Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female
• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• ProHealth Care, Inc: lead

MeSH Terms

Conditions

Vulvar Vestibulitis; Vulvodynia

Condition Hierarchy (Ancestors)

Vulvitis; Vulvar Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Limitations and Caveats

Early termination leading to small numbers of subjects analyzed were the choice of the participant to end participation. One participant became pregnant during the study. Other reasons were related to participant cost of healthcare visits.

Results Point of Contact

• Title: Linda LaBorde PT
• Organization: ProHealth Care

linda.laborde@phci.org

262-928-5139

Study Officials

• Linda A LaBorde, BS PT

  ProHealth Care, Inc

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 24, 2014
• First Posted: July 30, 2014
• Study Start: March 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: July 2, 2017
• Results First Posted: July 2, 2017

Record last verified: 2017-04