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Photobiomodulation for Myofascial Pelvic Pain

NCT05926752 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 28

Last updated 2023-07-03

No results posted yet for this study

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.

Conditions

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

Interventions

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

Sponsors & Collaborators

  • Orlando VA Medical Center

    lead FED

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2021-10-27
Primary Completion
2024-02-01
Completion
2024-08-01
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05926752 on ClinicalTrials.gov