Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia

NCT ID: NCT01149031

Last Updated: 2015-03-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-06-30
• Study Completion Date: 2013-12-31

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.

Conditions

Provoked Vestibulodynia

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

LOW LEVEL LASER SYSTEM

Intervention Type: DEVICE

LASER DIODE CLASS 3B,OMEGA XP

Placebo

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

Group Type: PLACEBO_COMPARATOR

LOW LEVEL LASER SYSTEM

Intervention Type: DEVICE

LASER DIODE CLASS 3B,OMEGA XP

Interventions

LOW LEVEL LASER SYSTEM

LASER DIODE CLASS 3B,OMEGA XP

Intervention Type: DEVICE

Other Intervention Names

LASER DIODE CLASS 3B,OMEGA XP

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Hadassah Medical Organization

OTHER

Sponsor Role: lead

Responsible Party

Ahinoam Lev-Sagie

Clinic for vulvovaginal disorders

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Ahinoam Lev-Sagie, MD

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization, Jerusalem

Locations

Ahinoam Lev-Sagie

Jerusalem, , Israel

Countries

Israel

Other Identifiers

ahinoam110-HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id