NCT05926752

Photobiomodulation for Myofascial Pelvic Pain

Photobiomodulation Therapy for Myofascial Pelvic Pain: A Randomized Clinical Study

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 28 (estimated)
• Sponsor: Orlando VA Medical Center · Federal
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Accepted

Summary

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.

Detailed description

Background: Myofascial pelvic pain (MFPP) is defined as pain in the pelvic floor muscles, the pelvic floor connective tissue, and the surrounding fascia. Standard treatment options of MFPP include pharmacotherapy and pelvic floor physical therapy (PT). In severe cases (approximately 25%) who are not responsive to therapy, pudendal blocks and trigger point injections (TPs) may be used to temporarily alleviate pain and improve function. However, these are more invasive and may require anesthesia. Photobiomodulation therapy (PBMT) delivered by a low-level laser emitter has recently emerged as a treatment option for musculoskeletal disorders such as neck and low back pain. In patients with vaginal musculoskeletal pain, PBMT is also thought to be effective with minimal side-effects. SoLá is low-level pelvic laser emitter / photobiomodulation device that has FDA approval for intravaginal use to specifically treat myofascial pelvic pain and chronic pelvic pain. Although it is FDA approved and thought to be effective and less invasive, photobiomodulation using SoLá has not been rigorously studied in randomized controlled trials (RCTs). Study Aims: The primary aim is to evaluate the efficacy of SoLá pelvic therapy by comparing reduction in overall pelvic pain between women who undergo 9 treatments of photobiomodulation with SoLá (approximately 1 treatment twice a week), compared to women who receive standard pelvic floor PT once a week for 8 weeks. The secondary aim is to compare dyspareunia, pain with sitting, and compliance with therapy between the two groups. Study Design and Methods: The investigators will conduct a RCT comparing overall pelvic pain (primary outcome), dyspareunia, and pain with sitting in women who receive PBMT with SoLá (group 1) vs. women who receive pelvic floor PT (group 2). Twenty-eight total participants will be randomized to either study group after providing informed consent. After enrollment, participants will be treated with 8 weekly treatments of pelvic PT or 9 treatments of SoLá (administered twice weekly). Patient outcomes will be evaluated at baseline (before treatment 1), midway through their treatment (before treatment 5 of SoLá and treatment 5 of PT), and at the end of their treatment (1-2 weeks after treatment 8 of PT/treatment 9 of SoLá and 3 months after treatment 8 of PT/treatment 9 of SoLá). Pain levels will be assessed using the Short Form McGill Pain Questionnaire (SF-MPQ) which assesses sensory and affective components of pain, Pain Interference Short Form which evaluates the effect of pain on quality of life, and pain severity on a 1-10cm Visual Analog Scale (VAS). Anticipated Results: The investigators hypothesize that women who undergo PBMT will demonstrate greater improvements in all pain outcomes when compared to pelvic floor PT.

Conditions

• Pelvic Pain
• Levator Ani Syndrome
• Spastic Pelvic Floor Syndrome
• Chronic Pelvic Pain Syndrome
• Myalgia of Pelvic Floor

Interventions

Type	Name	Description
DEVICE	SoLá therapy	SoLá therapy is a photobiomodulation device that works by stimulating mitochondria, soothing tense muscles, and promotes healing.
OTHER	Pelvic floor physical therapy	Physical therapy is manual myofascial release, muscles stretches, and exercises designed to help myofascial pelvic pain

Timeline

• Start date: 2021-10-27
• Primary completion: 2024-02-01
• Completion: 2024-08-01
• First posted: 2023-07-03
• Last updated: 2023-07-03

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study