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临床试验/NCT06337448
NCT06337448尚未招募不适用

Light Emitting Diode in the Treatment of Vulvodynia: a Pilot Study

Centro de Atenção ao Assoalho Pélvico2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2025年8月16日最近更新:
适应症

试验速览

阶段
不适用
状态
尚未招募
发起方
入组人数
10
试验地点
2
主要终点
Number of participants with treatment-related adverse events as assessed by Visual Analogue Scale.

研究概览

简要总结

Vulvar pain can be related to a specific cause (inflammation, cancer, trauma, infection) or can be classified as vulvodynia, when vulvar pain is idiopathic and lasts for at least three months. The main symptoms reported are pain, burning, erythema, increased sensitivity, itching and burning, which affect the quality of life, psycho-emotional well-being, relationships and sexual function of these women. Photobiomodulation has been described in the literature as an alternative to treat pain. Our group has studied blue LED for some vulvovaginal dysfunctions and, due to the positive sensory effects observed in patients with vaginal stenosis and genitourinary syndrome of menopause, it is hypothesized that this technique could also bring beneficial effects for women with vulvodynia. A pilot study will be carried out, with descriptive data, with 10 women with vulvodynia. Participants will be evaluated with a basic anamnestic questionnaire and sociodemographic data. The following questionnaires will be used: Female Sexual Function Index (FSFI), Sexual Quotient - Female Version, Vulvar Pain Assessment Questionnaire. After answering the questionnaires, the volunteer will undergo a perineal physical assessment by an experienced physiotherapist, which includes a) inspection of the genital region, reflex tests, assessment of the functions of the pelvic floor muscles, b) the cotton swab test to evaluate painful sensitivity in the vestibule, c) the tampon test to evaluate painful sensitivity in the introitus and vaginal canal. Pain assessments will be quantified by the visual analogue pain scale (VAS), which ranges from 0 (no pain) to 10 (maximum pain). At the end of the treatment, the participant will answer the questionnaires again, undergo reassessment of pain sensitivity in vulva, introitus and vaginal canal, of the function of the pelvic floor muscles and will be asked "What is your perception of improvement" and "What is your level of satisfaction with the treatment?". The answers will be giving according to a Likert Scale of five points. The LED application protocol will be carried out with external use equipment model Antares, from the company IBRAMED (Amparo, São Paulo, Brazil), with a cluster G2 applicator. The power will be 450mW/cm2 and dose 5J/cm2 for 2 minutes and 13 seconds (automatic programming) in 450nm waves (blue wavelength). The treatment consists of eight sessions, carried out daily, except on weekends.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • vulvodynia diagnosis

排除标准

  • patients diagnosed with vaginal infection
  • difficulty in understanding the proposed instruments
  • patients with chronic degenerative neurological diseases
  • pregnant women

结局指标

主要结局

Number of participants with treatment-related adverse events as assessed by Visual Analogue Scale.

时间窗: During the all 8 sessions (daily), at the end (one week after de beginning of the treatment) and one month after the end of the treatment.

To assess the safety of the treatment regarding the genital's sensation (burning, itching, pain) and genital's visual aspects (lesion, erosion, redness).

Evaluate the clinical response assessed by a questionnaire.

时间窗: At the beginning of the treatment and at the end (one week after de beginning of the treatment), 1, 3 and 6 months after the end treatment.

To assess the clinical effect of the treatment it will be used the Vulvar Pain Assessment Questionnaire: the higher the score, the greater the intensity of pain and impairment of the assessed domains.

Tolerability of participants to the treatment assessed by Likert Scale.

时间窗: During the all 8 sessions (daily) and at the end (one week after de beginning of the treatment).

To assess the tolerability of the patient according to the Likert 5 Points Scale: very comfortable, comfortable, nor comfortable nor discomfortable, discomfortable, impossible to tolerate the treatment.

Evaluate the clinical response assessed by the Visual Analogue Scale.

时间窗: At the beginning of the treatment and at the end (one week after de beginning of the treatment), 1, 3 and 6 months after the end treatment.

To assess the clinical effect of the treatment it will be used the Visual Analogue Scale (VAS), which varies from 0 to 10. The pain will be assessed on the swab test and the tampon test in the genital area. Minimum decrease in 2 points on the VAS will be interpretated as clinical effect.

次要结局

  • Evaluate the sexual function of women with vulvodynia by Female Sexual Function Index (FSFI).(At the beginning of the treatment and at the end (one week after de beginning of the treatment), 1, 3 and 6 months after the end of the treatment.)
  • Evaluate the sexual function of women with vulvodynia by Sexual Quotient - Female Version (SQ-FV).(At the beginning of the treatment and at the end (one week after de beginning of the treatment), 1, 3 and 6 months after the end treatment.)

研究者

发起方
Centro de Atenção ao Assoalho Pélvico
申办方类型
Other
责任方
Principal Investigator
主要研究者

Patricia Lordelo

Head of the CentroAAP

Centro de Atenção ao Assoalho Pélvico

研究点 (2)

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