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
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.
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.
Parallel
photobiomidulação
DeviceThe 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
Other interventionThe 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.
Visual numeric pain scale (VNS)
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.
Female sexual function - IFSF
The Female Sexual Function Index (FSFI) is a brief questionnaire, which can be self-administered, and which aims to assess female sexual response in six domains: sexual desire, sexual arousal, vaginal lubrication, orgasm, sexual satisfaction and pain. To do this, it presents 19 questions that assess sexual function over the last four weeks. For each question there is an answer pattern whose options receive scores from 0 to 5 in an increasing manner in relation to the presence of the function questioned. Only in questions about pain the score is defined inverted. A total score is presented at the end of the application, resulting from the sum of the scores for each domain multiplied by a factor that homogenizes the influence of each domain on the total score.
Quality of life - SF-36
It consists of a multidimensional questionnaire made up of 36 items, encompassed in 8 scales or domains, which are: functional capacity, physical aspects, pain, general health status, vitality, social aspects, emotional aspects and mental health. It presents a score that ranges from 0 (zero) to 100 (obtained through Raw Scale calculation), where zero corresponds to the worst general state of health and 100 corresponds to the best state of health.
Inflammatory markers - IL6, IL10 and prostaglandins
To observe the inflammatory status of the volunteers, the plasma concentration of IL-6 and IL-10 will be measured using the ELISA immunoassay method according to the manufacturer's instructions. To observe the inflammatory status of the volunteers, the plasma concentration of PGE2 - Multi-Format ELISA Kit - K051-H1 / K051-H5 will be titrated by ELISA assays as indicated by the manufacturer
Satisfaction scale referred
A satisfaction scale referred to with the treatment will be applied where the volunteer will have to give a number from 1 to 10 to how satisfied she is with the result of the treatment
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