Effects of Photobiomodulation on Pain and Sexual Function in Women With Dyspareunia: Randomized Clinical Trial
NCT Number: NCT06460415
Status: NOT_YET_RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Dyspareunia|Pain|Sexual Dysfunction
Interventions: DEVICE: photobiomidulação|OTHER: Placebo
Sponsor: Federal University of Health Science of Porto Alegre
Sex: FEMALE
Age: ADULT
Enrollment: 52
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: TRIPLE (PARTICIPANT, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: TREATMENT
Start Date: 2024-06
Completion Date: 2027-08
Locations: Universidade Federal de Ciências da Saúde de Porto Alegre, Porto Alegre, RS, 90050-170, Brazil

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

Primary Outcome Measures: 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., 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.
Secondary Outcome Measures: 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., will be applied at six moments: before starting treatment, after the end of 8 treatment sessions and in follow-ups of 15, 30, 90 and 180 days.|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., will be applied at six moments: before starting treatment, after the end of 8 treatment sessions and in follow-ups of 15, 30, 90 and 180 days.|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, will be applied pre-intervention, after 4 interventions and at the end of 8 interventions|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, It will be applied at the end of the 8 treatment sessions and in follow-ups of 15, 30, 90 and 180 days.