Vaginal Photobiomodulation for Chronic Pelvic Pain

Launched by SOLA PELVIC THERAPY · Nov 1, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment for women suffering from chronic pelvic pain, which is pain that lasts for three months or longer. The researchers want to find out if using a special type of light therapy, called photobiomodulation, can help reduce this pain. Participants will receive eight sessions of this treatment and researchers will also check if it helps ease pain during daily activities like sitting, standing, urinating, having bowel movements, and during intercourse.

To join the study, women need to be at least 18 years old and have a certain level of pelvic pain. However, there are some conditions that might prevent someone from participating, such as having had similar treatments before, being currently pregnant, or having certain health issues. If eligible, participants can expect to receive the treatment and share their experiences through surveys. This trial is a great opportunity for women looking for new ways to manage their chronic pelvic pain.

Gender

FEMALE

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or older;
• • 2. CPP for 3 months or longer;
• • 3. Overall pelvic pain severity ≥4 in the last 7 days;
• • 4. Pelvic muscle tenderness pain level ≥4.
• Exclusion Criteria:
• • 1. Previous vaginal or vulvar laser therapy;
• • 2. Receiving concurrent pelvic physical therapy;
• • 3. Unable to tolerate vaginal/pelvic examination
• • 4. Taking drugs that have heat- or light- sensitive contraindications;
• • 5. Subjectively reports abnormal or decreased sensation in the vagina or rectum;
• • 6. History of cancer of the cervix, vagina, uterus, bladder, or vulva or suspected of having neoplasia or pre-cancerous lesions;
• • 7. History of autoimmune inflammatory conditions such as vulvar lichen sclerosis or other types of dermatoses;
• • 8. History of vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown;
• • 9. Less than 6 months post-partum;
• • 10. Actively trying to get pregnant or not willing to use contraception during the trial;
• • 11. Positive pregnancy test or planning to get pregnant during the study;
• • 12. Vaginal discharge or bleeding concerning for neoplasia, infectious, or autoimmune condition; \*
• • 13. Pelvic pain has not been fully evaluated or pain is not confirmed as chronic pelvic pain;
• • 14. Does not speak, read, or writes English and thus cannot complete surveys;
• • 15. Does not have access to smart digital devices or computer, or cannot receive emails.