Ignite Creation Date:
2024-05-05 @ 10:36 PM
Last Modification Date:
2024-10-26 @ 10:21 AM
Study NCT ID:
NCT01149031
Status:
TERMINATED
Last Update Posted:
2015-03-24
First Post:
2010-06-16
Brief Title:
Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia
Sponsor:
Hadassah Medical Organization
Organization:
Hadassah Medical Organization
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2015-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
LLLT
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 womens sexuality and psychological well-being The diagnosis of provoked vestibulodynia is usually made by ascertaining if the patient fulfills modified Friedrichs 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
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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None