Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia

Provoked Vestibulodynia Clinical Trial

— LLLT  

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01149031
• Other study ID #: ahinoam110-HMO-CTIL
• Status: Terminated
• Phase: N/A
• First received: June 16, 2010
• Last updated: March 21, 2015
• Start date: June 2010
• Est. completion date: December 2013

Study information

• Verified date: March 2015
• Source: Hadassah Medical Organization
• Contact: n/a
• Is FDA regulated: No
• Health authority: Israel: Ministry of health- Director general
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 34
• Est. completion date: December 2013
• Est. primary completion date: October 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Provoked Vestibulodynia
• Vulvar Vestibulitis
• Vulvodynia

Intervention

Device:
• LOW LEVEL LASER SYSTEM
LASER DIODE CLASS 3B,OMEGA XP

Locations

Country	Name	City	State
Israel	Ahinoam Lev-Sagie	Jerusalem

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in vestibular pain level(as measured by variable parameters)	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)	7 weeks (at the end of treatment protocol)	No