Effects of Photobiomodulation on Pain and Sexual Function in Women With Dyspareunia: Randomized Clinical Trial

NCT06460415 · tracked via the Priya Life Science Brazil tracker

Sponsor

Federal University of Health Science of Porto Alegre

Phase

Not applicable

Started

2024-06

Last updated

2024-06-14

Condition(s) studied

DyspareuniaPainSexual Dysfunction

Investigational drug(s) / intervention(s)

photobiomidulaçãoPlacebo

photobiomidulação: The volunteers in the GFBM group will undergo 8 sessions of a combined red and infrared laser protocol with 4J of infrared power and 4J of red power. Being applied at 8 points (4 red and 4 infrared) in the vulvar region and 8 points (4 red and 4 infrared) points in the intravaginal pelvic floor region. The MMO semiconductor laser device (GaA1As and InGaAlP) will be used with an area of the output laser beam at the NOZZLE of the laser pen of 3mm2 and wavelengths of 660nm (Red Laser) and 808nm (Infrared Laser) with a power of 100mW. The application will be carried out with the volunteers on a stretcher, in the supine position, gynecological position, with the knees and hips flexed and in abduction, feet supported on the stretcher.

Placebo: The placebo control will be administered using the same device as the GFBM, but without any therapeutic dose delivery. Furthermore, the irradiated sites and irradiation time will be the same as PBMT. Volunteers will receive a total dose of 0 J in placebo mode. This treatment was also carried out in 8 sessions.

Study summary

The goal of this clinical trial is to compare the effects of vulvar and intravaginal application of PBM compared to the sham group on pain and sexual function in women with dyspareunia . The main question \[s\] it aims to answer are:

* What are the effects of vulvar and intravaginal application of photobiomodulation (PBM) compared to the sham group on the sexual function of women with dyspareunia in the immediate post-intervention moments and in follow-ups of 15, 30, 90 and 180 days?
* What are the effects of vulvar and intravaginal application of photobiomodulation (PBM) compared to the sham group on pain in women with dyspareunia in the immediate post-intervention moments and in follow-ups of 15, 30, 90 and 180 days?

Participants will The GPBM photobiomodulation group will receive, during the 8 days of intervention, application in 8 points (4 red and 4 infrared) in the vulvar region and 8 points (4 red and 4 infrared) in the intravaginal pelvic floor region of PBM while the GS group will receive simulation application of PBM in the same number of vulvar and intravaginal points, in the same places where it was applied in the GPBM group. To see if 8 applications of photobiomodulation are really capable of reducing pain and improving sexual function in women with dyspareunia

Eligibility

Sex

FEMALE

Min age

18 Years

Max age

45 Years

Healthy volunteers

Inclusion Criteria: * Women, aged between 18 and 45 years classified with dyspareunia criteria, according to the guidelines of the European Association of Urology guideline (2022)2, who report pain in relationship greater than 3 on the visual numeric pain scale at the beginning of participation in the research , who present sensitivity to unidigital palpation of the pelvic muscular wall (e.g., levator ani, coccygeus, obturator) and who report feeling pain during penetration for at least 6 months. Exclusion Criteria: * Women with a history of neurological or oncological diseases or bone fractures in the pelvic region, in addition to radiculopathies, decompensated heart disease or metabolic disorders, pregnant women, lactating women, women in menopause, women with difficulties in understanding written or spoken language, in use of photosensitizing drugs, who present an inflammatory condition or have used anti-inflammatories on the day of the evaluation, red flags (post-coital bleeding, abrupt unexplained weight loss, presence of a mass visible on ultrasound, macroscopic or microscopic hematuria), who have a diagnosis of painful bladder syndrome, irritable bowel syndrome, interstitial cystitis, fibromyalgia. Who have a history of spine surgery or have undergone any surgical intervention with general anesthesia in the last 120 days. Who is currently undergoing pelvic physiotherapy treatment.

Primary outcome measure(s)

Visual numeric pain scale (VNS) — The visual pain scale will be evaluated at the beginning and at the end of each laser application, in addition to being applied immediately after the intervention and in follow-ups of 15, 30, 90 and 180 days.
The number 0 represents no pain and, gradually, the increase in pain intensity is represented by the numerical increase on the scale (values from 1-3: mild pain; 4-6: moderate pain; and 7-10: severe pain). The primary outcome will be considered clinically significant if there is a reduction of at least 2 points in the overall severity of pain compared to baseline after 8 applications, in any of the time intervals measured.

Trial sites (1)

Facility	City	Region	Status
Universidade Federal de Ciências da Saúde de Porto Alegre	Porto Alegre	Rio Grande do Sul

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06460415 on ClinicalTrials.gov ↗ ← All trials in Brazil