VulvodyniaNCT06337448
Light Emitting Diode in the Treatment of Vulvodynia
A study testing Blue LED in people with Vulvodynia, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Vulvodynia
- What is being tested?
- Blue LED
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteBrazil
- Study dates
- 16 Aug 2025to Dec 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- vulvodynia diagnosis
Who cannot join
- patients diagnosed with vaginal infection
- difficulty in understanding the proposed instruments
- patients with chronic degenerative neurological diseases
- pregnant women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Brazil1 site
Centro de Atenção ao assoalho pélvico
Salvador, Estado de Bahia, 40290000
Patricia Lordelo, post doc, +5571988592400, pvslordelo@hotmail.com
About this study
Official title: 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.
- Conditions
- Vulvodynia
- Being tested
- Blue LED
- Keywords
- vulvodynia, Light-emitting diode
- Medical subject headings
- Vulvodynia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blue LEDDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Light-emitting diode | Experimental | 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. Receives: Device: Blue LED |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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 outcomes (2)
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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start16 Aug 2025 (estimated)
- Primary completionAug 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for VulvodyniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro de Atenção ao Assoalho Pélvico
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Patricia Lordelo, Centro de Atenção ao Assoalho Pélvico
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06337448
- Sponsor's protocol ID
- 74090923.9.0000.5544
- Status last verified
- Aug 2024
- First submitted
- 4 Mar 2024
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Light Emitting Diode in the Treatment of Vulvodynia: a Pilot Study
- ClinicalTrials.gov ID
- NCT06337448
- Acronym / sponsor ID
- 74090923.9.0000.5544
- Conditions
- Vulvodynia
- Keywords
- vulvodynia, Light-emitting diode
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Centro de Atenção ao Assoalho PélvicoUniversity, hospital or other
- Study start
- 16 Aug 2025 (estimated)
- Primary completion
- Aug 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 29 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Light-emitting diode | Experimental | Device: Blue LEDThe 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- vulvodynia diagnosis
Key exclusion criteria (4 listed)
- patients diagnosed with vaginal infection
- difficulty in understanding the proposed instruments
- patients with chronic degenerative neurological diseases
- pregnant women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blue LEDThe 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. | Device | Light-emitting diode |
Primary outcome
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.
To assess the safety of the treatment regarding the genital's sensation (burning, itching, pain) and genital's visual aspects (lesion, erosion, redness).
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).
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.
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.
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.
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.
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.
2 secondary outcomes
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Vulvodynia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blue LED in people with Vulvodynia, run by Centro de Atenção ao Assoalho Pélvico at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Patricia V Lordelo, Phd (+5571996592400, pvslordelo@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.