Light Emitting Diode in the Treatment of Vulvodynia

Official title

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

Overview

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.

Interventions

• Device Blue LED
  The patient will remain naked, in a closed room, in the lithotomy position on a gynecological table, and he LED will be positioned in the direction of the patient's genitalia, keeping the internal and external vulvar lips open, so the LED can reach the largest possible region for therapeutic action.

Primary outcome measures

• Number of participants with treatment-related adverse events as assessed by Visual Analogue Scale. [Time frame: 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.]
• Tolerability of participants to the treatment assessed by Likert Scale. [Time frame: During the all 8 sessions (daily) and at the end (one week after de beginning of the treatment).]
• Evaluate the clinical response assessed by the Visual Analogue Scale. [Time frame: 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.]
• Evaluate the clinical response assessed by a questionnaire. [Time frame: 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.]

Secondary outcome measures (2)

• Evaluate the sexual function of women with vulvodynia by Female Sexual Function Index (FSFI). [Time frame: 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). [Time frame: 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.]

Eligibility criteria

Inclusion criteria

• vulvodynia diagnosis

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Brazil · 1 center

• Centro de Atenção ao assoalho pélvico — Salvador

Identifiers

NCT: NCT06337448 · 74090923.9.0000.5544

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗