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Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia (LLLT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01149031
Recruitment Status : Terminated
First Posted : June 23, 2010
Last Update Posted : March 24, 2015
Information provided by (Responsible Party):
Ahinoam Lev-Sagie, Hadassah Medical Organization

Brief Summary:

Provoked vestibulodynia, previously called vulvar vestibulitis syndrome, is clinically defined as chronic, unexplained, vulvar pain or discomfort confined to the vulvar vestibule in response to contact or pressure. In addition, many patients also have pain in response to non-sexual activities such as tampon insertion, gynecological examinations or physical pursuits such as bicycle riding; the severity of other vulvo-vaginal symptoms such as itching, burning and irritation varies. Once women with provoked vestibulodynia develop the syndrome, symptoms may last for months or years; as a result, provoked vestibulodynia has a profound effect on women's sexuality and psychological well-being. The diagnosis of provoked vestibulodynia is usually made by ascertaining if the patient fulfills modified Friedrich's criteria, consisting of 1) a history of vulvar pain, dyspareunia or pain with tampon insertion, 2) tenderness of the vestibule when being touched with a cotton-tip applicator and 3) no identifiable cause for the pain.

The etiology of this condition remains unknown. Proposed causes include chronic inflammation, peripheral neuropathy, genetic, immunologic and hormonal factors, infectious, psychological disorders, sexual dysfunction or disturbance in the central nervous system. Because the cause of provoked vestibulodynia remains unknown, many different treatments have been described for this condition, including topical and intra-lesional corticosteroids, topical anesthetics such as lidocaine, topical estrogen, topical or oral antidepressants or anti-convulsants, biofeedback or physical therapy, surgical resection of the involved tissue (vestibulectomy) and a variety of complementary and alternative therapies.

Low level laser therapy (LLLT) is an emerging medical technique in which exposure to low-level laser light or light emitting diodes might stimulate or inhibit cellular function, possibly leading to beneficial clinical effects. Clinical applications that show some potential of effectiveness include treating soft tissue injury, chronic pain, and wound healing. The usage of low level laser therapy was found effective in various pain syndromes, and has no side effects.

Since inflammatory mechanisms have been proposed in the pathogenesis of provoked vestibulodynia, and as there is no effective therapy for this syndrome, the investigators intend to study whether low level laser therapy might be an effective therapy for provoked vestibulodynia.

Condition or disease Intervention/treatment
Provoked Vestibulodynia Device: LOW LEVEL LASER SYSTEM

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 34 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Study Start Date : June 2010
Primary Completion Date : October 2012
Study Completion Date : December 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: low level laser therapy, using a probe

The treatment will be done by using a LLL-probe touching several areas of the vulvar vestibule, according to the selected protocol.

Every patient will be treated twice weekly for 6 weeks.

Placebo Comparator: Placebo
The patients will be treated with placebo-probe, according to the same protocol

Primary Outcome Measures :
  1. Change in vestibular pain level(as measured by variable parameters) [ Time Frame: 7 weeks (at the end of treatment protocol) ]
    Response to treatment will be assessed by change in pain by numeric rating scale of a weekly Tampon Test, change in overall daily pain intensity (24 hour numeric rating scale), frequency of sexual intercourse, the change in intercourse pain numeric rating scale, and the cotton swab test pain level by verbal reporting scale. In addition, patients will complete quality-of-life questionnaires (Brief Pain Inventory and Neuropathic Pain Scale)

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • Patients with provoked vestibulodynia who meet modified Friedrich's criteria, after exclusion of other vulvar disorders, who are willing to participate in the study.

Exclusion Criteria:

  • Pregnancy

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01149031

Ahinoam Lev-Sagie
Jerusalem, Israel
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Ahinoam Lev-Sagie, MD Hadassah Medical Organization, Jerusalem

Responsible Party: Ahinoam Lev-Sagie, Clinic for vulvovaginal disorders, Hadassah Medical Organization Identifier: NCT01149031     History of Changes
Other Study ID Numbers: ahinoam110-HMO-CTIL
First Posted: June 23, 2010    Key Record Dates
Last Update Posted: March 24, 2015
Last Verified: March 2015

Keywords provided by Ahinoam Lev-Sagie, Hadassah Medical Organization:
Provoked Vestibulodynia
Low Level Laser Therapy

Additional relevant MeSH terms:
Vulvar Vestibulitis
Vulvar Diseases
Genital Diseases, Female