Ignite Creation Date:
2024-06-16 @ 11:52 AM
Last Modification Date:
2024-10-26 @ 3:32 PM
Study NCT ID:
NCT06460415
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-06-14
First Post:
2024-06-11
Brief Title:
Effects of Photobiomodulation on Pain and Sexual Function in Women With Dyspareunia Randomized Clinical Trial
Sponsor:
Federal University of Health Science of Porto Alegre
Organization:
Federal University of Health Science of Porto Alegre
Study Overview
Official Title:
Effects of Photobiomodulation on Pain and Sexual Function in Women With Dyspareunia Randomized Clinical Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-06
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:
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
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
Detailed Description:
Female sexual dysfunction is known as the disorder experienced by a woman when changes occur in her usual sexual behavior It is estimated that between 16 and 40 of women suffer from some form of sexual dysfunction and this percentage increases with age1 Among the painful disorders dyspareunia stands out which is defined as pain perceived in the pelvis associated with sex with penetration It can be applied to women and men It usually occurs with penile penetration but is often associated with pain during the insertion of any object It can apply to anal and vaginal intercourse It is classically subdivided into superficial when it affects the vulva and vaginal entrance and deep when the painful area is the cervix bladder andor the lower part of the pelvis2 Another classification divides it into primary associated with pain at the beginning of sexual life and secondary when it appears later3 It directly affects physical health as well as sexual and mental well-being Consequently it can lead to depression anxiety and low self-esteem in women who experience it4 Studies show an association between hyperactivity of the pelvic muscles and dyspareunia which can have a significant impact on physical and mental health leading to problems such as depression anxiety hypervigilance to pain negative body image and low self-esteem in addition to the possibility of leading to other sexual dysfunctions5 Multidisciplinary treatment is highly recommended in this population and aims to address the various physical emotional and behavioral aspects involved in sexual dysfunctions This approach involves the collaboration of a team made up of specialized professionals such as gynecologists physiotherapists sex therapists psychologists andor psychiatrists Among these professionals physiotherapy stands out as an intervention capable of improving sexual health through individualized approaches for each patient Considering that many patients with dyspareunia do not respond adequately to conventional drug therapy there is a clear need to seek new therapeutic alternatives such as photobiomodulation PBM Previous studies show positive results in the use of PBM in improving pain related to musculoskeletal and arthritic conditions Furthermore the application of PBM in the area of pelvic physiotherapy has been expanded A study carried out by Lev-Sagie et al6 showed positive results in the use of photobiomodulation in women with vestibulodynia in relation to pain Previous studies also indicate that intravaginal application of PBM has been effective in alleviating pain in conditions related to chronic pelvic pain endometriosis and pelvic pain of myofascial origin which suggests that photobiomodulation may be a promising therapy for women with dyspareunia7 89 In recent years research has been carried out to investigate the presence and increase of inflammatory mediators in different painful musculoskeletal disorders10-14 A study that applied photobiomodulation to patients with low back pain observed changes in some biomarkers in plasma or microdialysate indicating that patients with low back pain who receive photobiomodulation may present changes in the levels of inflammatory mediators15 But to date few studies have been carried out on this topic none of them applied to women with dyspareunia The scarcity of studies standardizing an application protocol which observes time of effect and analysis of inflammatory biomarkers in the use of photobiomodulation in women with dyspareunia justifies the need for research on the topic Therefore the objective of this study is to compare the effects of vulvar and intravaginal application of PBM compared to the sham group on the pain and sexual function of women with dyspareunia in the immediate post-intervention moments and in follow-ups of 15 30 90 and 180 days
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?:
None
Is an FDA AA801 Violation?:
None