Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia

NCT01149031 | Terminated

• 1 other identifier: ahinoam110-HMO-CTIL
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

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

Keywords

Provoked Vestibulodynia; Low Level Laser Therapy

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (2)

low level laser therapy, using a probe

ACTIVE COMPARATOR

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.

Device: LOW LEVEL LASER SYSTEM

Placebo

PLACEBO COMPARATOR

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

Device: LOW LEVEL LASER SYSTEM

Interventions

LOW LEVEL LASER SYSTEM DEVICE

LASER DIODE CLASS 3B,OMEGA XP

Also known as: LASER DIODE CLASS 3B,OMEGA XP

Placebo; low level laser therapy, using a probe

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may not qualify if:

• Pregnancy

Sponsors & Collaborators

• Hadassah Medical Organization: lead

Study Sites (1)

Ahinoam Lev-Sagie

Jerusalem, Israel

Location

Study Officials

• Ahinoam Lev-Sagie, MD

  Hadassah Medical Organization, Jerusalem

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinic for vulvovaginal disorders

Study Record Dates

• First Submitted: June 16, 2010
• First Posted: June 23, 2010
• Study Start: June 1, 2010
• Primary Completion: October 1, 2012
• Study Completion: December 1, 2013
• Last Updated: March 24, 2015

Record last verified: 2015-03

Locations

IL (1)