Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06337448
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-29
First Post:
2024-03-04
Brief Title:
Light Emitting Diode in the Treatment of Vulvodynia
Sponsor:
Centro de Atenção ao Assoalho Pélvico
Organization:
Centro de Atenção ao Assoalho Pélvico
Study Overview
Official Title:
Light Emitting Diode in the Treatment of Vulvodynia a Pilot Study
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 450mWcm2 and dose 5Jcm2 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None