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临床试验/NCT01149031
NCT01149031终止不适用

Low Level Laser Therapy for the Treatment of Provoked Vestibulodynia

Hadassah Medical Organization1 个研究点 分布在 1 个国家目标入组 34 人开始时间: 2010年6月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
34
试验地点
1
主要终点
Change in vestibular pain level(as measured by variable parameters)

研究概览

简要总结

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Triple (Participant, Care Provider, Investigator)

入排标准

年龄范围
18 Years 至 50 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients with provoked vestibulodynia who meet modified Friedrich's criteria, after exclusion of other vulvar disorders, who are willing to participate in the study.

排除标准

  • Pregnancy

结局指标

主要结局

Change in vestibular pain level(as measured by variable parameters)

时间窗: 7 weeks (at the end of treatment protocol)

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)

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Ahinoam Lev-Sagie

Clinic for vulvovaginal disorders

Hadassah Medical Organization

研究点 (1)

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