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

This study has been terminated.
Sponsor:
Information provided by (Responsible Party):
Ahinoam Lev-Sagie, Hadassah Medical Organization
ClinicalTrials.gov Identifier:
NCT01149031
First received: June 16, 2010
Last updated: December 13, 2012
Last verified: December 2012
  Purpose

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 Intervention
Provoked Vestibulodynia
Device: LOW LEVEL LASER SYSTEM

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

Further study details as provided by Hadassah Medical Organization:

Primary Outcome Measures:
  • Change in vestibular pain level(as measured by variable parameters) [ Time Frame: 7 weeks (at the end of treatment protocol) ] [ Designated as safety issue: No ]
    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)


Enrollment: 34
Study Start Date: June 2010
Estimated Study Completion Date: February 2013
Primary Completion Date: October 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

Device: LOW LEVEL LASER SYSTEM
LASER DIODE CLASS 3B,OMEGA XP
Other Name: LASER DIODE CLASS 3B,OMEGA XP
Placebo Comparator: Placebo
The patients will be treated with placebo-probe, according to the same protocol
Device: LOW LEVEL LASER SYSTEM
LASER DIODE CLASS 3B,OMEGA XP
Other Name: LASER DIODE CLASS 3B,OMEGA XP

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01149031

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

No publications provided

Responsible Party: Ahinoam Lev-Sagie, Clinic for vulvovaginal disorders, Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT01149031     History of Changes
Other Study ID Numbers: ahinoam110-HMO-CTIL
Study First Received: June 16, 2010
Last Updated: December 13, 2012
Health Authority: Israel: Ministry of health- Director general

Keywords provided by Hadassah Medical Organization:
Provoked Vestibulodynia
Low Level Laser Therapy

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

ClinicalTrials.gov processed this record on October 19, 2014