Light Emitting Diode in the Treatment of Vulvodynia

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

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.

Study Overview

• Status: Recruiting
• Conditions: Vulvodynia
• Intervention / Treatment: Device: Blue LED

• Study Type: Interventional
• Enrollment (Estimated): 10
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Patricia V Lordelo, Phd; Phone Number: +5571996592400; Email: pvslordelo@hotmail.com

Study Locations

• Brazil
  • Bahia
    • Salvador, Bahia, Brazil, 40290000
      • Recruiting
      • Centro de Atenção ao assoalho pélvico
      • Contact: Patricia Lordelo, post doc; Phone Number: +5571988592400; Email: pvslordelo@hotmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: 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.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of participants with treatment-related adverse events as assessed by Visual Analogue Scale.	To assess the safety of the treatment regarding the genital's sensation (burning, itching, pain) and genital's visual aspects (lesion, erosion, redness).	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.	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.	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.	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.	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.	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.	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

Outcome Measure	Measure Description	Time Frame
Evaluate the sexual function of women with vulvodynia by Female Sexual Function Index (FSFI).	The FSFI has 19 items, the score varies from 2 to 36, and the cut-off point is 26, meaning that scores of 26 or less classify the patient as having sexual dysfunction.	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).	The FQ-SV has 10 items and the score varies from 0 to 100. Higher values indicate better sexual performance/satisfaction. The score classification is 82-100 points: good to excellent; 62-80 points: regular to good; 42-60 points: unfavorable to fair; 22-40 points: poor to unfavorable; 0-20 points: nil to bad. A cutoff point of 60 (between 48 and 84) was established as a means of screening for female sexual dysfunction.	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.

Collaborators and Investigators

• Sponsor: Centro de Atenção ao Assoalho Pélvico

Study record dates

Study Major Dates

• Study Start (Actual): January 16, 2024
• Primary Completion (Estimated): January 1, 2026
• Study Completion (Estimated): December 1, 2026

Study Registration Dates

• First Submitted: March 4, 2024
• First Submitted That Met QC Criteria: March 22, 2024
• First Posted (Actual): March 29, 2024

Study Record Updates

• Last Update Posted (Actual): March 29, 2024
• Last Update Submitted That Met QC Criteria: March 22, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: vulvodynia; Light-emitting diode
• Additional Relevant MeSH Terms: Vulvar Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Female; Vulvodynia
• Other Study ID Numbers: 74090923.9.0000.5544

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No