Photobiomodulation for Myofascial Pelvic Pain

Status unconfirmed · Not applicable

Conditions studied: Pelvic Pain, Levator Ani Syndrome, Spastic Pelvic Floor Syndrome, Chronic Pelvic Pain Syndrome, Myalgia of Pelvic Floor

In brief

The goal of this clinical trial is to evaluate the efficacy of photobiomodulation of the pelvic floor muscles in female Veterans with chronic pelvic pain. The main questions it aims to answer are: * Is there a difference in reduction in overall pelvic pain between women who undergo photobiomodulation compared to women who received pelvic floor physical therapy? * Is there a difference in compliance with therapy between the two groups? Participants will be randomized to treatment with either 9 treatments of photobiomodulation (two treatments per week) or 8 weeks of pelvic floor physical therapy (one treatment a week). Researchers will compare both groups to see if there is a difference in overall pelvic pain reduction.

Key facts

Study ID

NCT05926752

Run by

Orlando VA Medical Center

People needed

28

Starts

2021-10-27

Expected to finish

2024-08-01

Last updated by the study team

2023-07-03

Who can join

Age: 18 and older. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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

You may not qualify if…

• 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 it is running

• Orlando VA Medical Center — Orlando, Florida, United States (enrolling)

Full record on ClinicalTrials.gov

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