Light Emitting Diode in the Treatment of Vulvodynia

NCT ID: NCT06337448

Last Updated: 2024-08-21

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-08-16
• Study Completion Date: 2026-12-31

Brief Summary

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.

Conditions

Vulvodynia

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Light-emitting diode

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. The patient will remain naked, in a closed room, in the lithotomy position on a gynecological table, in the presence of only a physiotherapist specializing in women's health, who will apply the light.

Group Type: EXPERIMENTAL

Blue LED

Intervention Type: DEVICE

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.

Interventions

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.

Intervention Type: DEVICE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Centro de Atenção ao Assoalho Pélvico

OTHER

Sponsor Role: lead

Responsible Party

Patricia Lordelo

Head of the CentroAAP

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Centro de Atenção ao assoalho pélvico

Salvador, Estado de Bahia, Brazil

Countries

Brazil

Central Contacts

Patricia V Lordelo, Phd

Role: CONTACT

pvslordelo@hotmail.com

+5571996592400

Facility Contacts

Patricia Lordelo, post doc

Role: primary

pvslordelo@hotmail.com

+5571988592400

Other Identifiers

74090923.9.0000.5544

Identifier Type: -

Identifier Source: org_study_id