Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia (LLLT)
Primary Purpose
Provoked Vestibulodynia
Status
Terminated
Phase
Not Applicable
Locations
Israel
Study Type
Interventional
Intervention
LOW LEVEL LASER SYSTEM
Sponsored by
About this trial
This is an interventional treatment trial for Provoked Vestibulodynia focused on measuring Provoked Vestibulodynia, Low Level Laser Therapy
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
Sites / Locations
- Ahinoam Lev-Sagie
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
low level laser therapy, using a probe
Placebo
Arm Description
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.
The patients will be treated with placebo-probe, according to the same protocol
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
Full Information
NCT ID
NCT01149031
First Posted
June 16, 2010
Last Updated
March 21, 2015
Sponsor
Hadassah Medical Organization
1. Study Identification
Unique Protocol Identification Number
NCT01149031
Brief Title
Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia
Acronym
LLLT
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Terminated
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2012 (Actual)
Study Completion Date
December 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hadassah Medical Organization
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Provoked Vestibulodynia
Keywords
Provoked Vestibulodynia, Low Level Laser Therapy
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
low level laser therapy, using a probe
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
The patients will be treated with placebo-probe, according to the same protocol
Intervention Type
Device
Intervention Name(s)
LOW LEVEL LASER SYSTEM
Other Intervention Name(s)
LASER DIODE CLASS 3B,OMEGA XP
Intervention Description
LASER DIODE CLASS 3B,OMEGA XP
Primary Outcome Measure Information:
Title
Change in vestibular pain level(as measured by variable parameters)
Description
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)
Time Frame
7 weeks (at the end of treatment protocol)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ahinoam Lev-Sagie, MD
Organizational Affiliation
Hadassah Medical Organization, Jerusalem
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ahinoam Lev-Sagie
City
Jerusalem
Country
Israel
12. IPD Sharing Statement
Learn more about this trial
Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia
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