Using light therapy to treat pelvic pain in female Veterans
Photobiomodulation Therapy for Myofascial Pelvic Pain: A Randomized Clinical Study
This study tests whether light therapy can help female Veterans with chronic pelvic pain feel better compared to traditional pelvic floor physical therapy.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 28 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Orlando VA Medical Center Federal |
| Locations | 1 site (Orlando, Florida) |
| Trial ID | NCT05926752 on ClinicalTrials.gov |
What this trial studies
This clinical trial evaluates the effectiveness of photobiomodulation therapy on pelvic floor muscles in female Veterans suffering from chronic pelvic pain. Participants will be randomly assigned to receive either 9 sessions of photobiomodulation or 8 weeks of pelvic floor physical therapy. The study aims to compare the reduction in overall pelvic pain between the two groups and assess compliance with the treatment protocols. The therapy utilizes a low-level laser device, SoLá, which is FDA approved for treating myofascial pelvic pain.
Who should consider this trial
Good fit: Ideal candidates are female Veterans aged 18 and older with a clinically diagnosed myofascial pelvic pain.
Not a fit: Patients with prior pelvic floor therapy or those with certain medical conditions, such as active infections or cancer history, may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a less invasive and effective treatment option for women suffering from chronic pelvic pain.
How similar studies have performed: While photobiomodulation has shown promise in treating other musculoskeletal disorders, this specific application for pelvic pain is novel and has not been rigorously tested in randomized controlled trials.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Clinically diagnosed MFPP * Age ≥ 18 * Able to provide informed consent * English speaking * Agree not to participate in any other form of treatment of myofascial pelvic pain for 3 months after end of trial Exclusion Criteria: * Prior pelvic floor physical therapy or SoLá therapy for pelvic pain * Pregnancy documented by urine or blood * Taking drugs that have heat- or light- sensitive contraindications * Reporting decreased sensation in the vagina or rectum or if they are found to have abnormalities on the external neurosensory exam of the vagina * Have a known history of cancer of the cervix, vagina, uterus, bladder, or vulva or suspected to have neoplasia or pre-cancerous lesions * Have an active infection of the bladder, vagina, vulva, or urethra * Have active vaginal bleeding or blood in the vaginal canal * Have evidence of active vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown * Cannot tolerate vaginal examination either due to discomfort, pain or history or traumatic experience
Where this trial is running
Orlando, Florida
- Orlando VA Medical Center — Orlando, Florida, United States (Recruiting)
Study contacts
- Study coordinator: Chensi Ouyang, MD
- Email: chensi.ouyang@va.gov
- Phone: 4076314010
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.