RECRUITING

Photobiomodulation for Myofascial Pelvic Pain

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Photobiomodulation Therapy for Myofascial Pelvic Pain: A Randomized Clinical Study

Quick Facts

Study Start:2021-10-27
Study Completion:2024-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05926752

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:FEMALE
Accepts Healthy Volunteers:Yes
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Clinically diagnosed MFPP
  2. * Age ≥ 18
  3. * Able to provide informed consent
  4. * English speaking
  5. * Agree not to participate in any other form of treatment of myofascial pelvic pain for 3 months after end of trial
  1. * Prior pelvic floor physical therapy or SoLá therapy for pelvic pain
  2. * Pregnancy documented by urine or blood
  3. * Taking drugs that have heat- or light- sensitive contraindications
  4. * Reporting decreased sensation in the vagina or rectum or if they are found to have abnormalities on the external neurosensory exam of the vagina
  5. * Have a known history of cancer of the cervix, vagina, uterus, bladder, or vulva or suspected to have neoplasia or pre-cancerous lesions
  6. * Have an active infection of the bladder, vagina, vulva, or urethra
  7. * Have active vaginal bleeding or blood in the vaginal canal
  8. * Have evidence of active vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown
  9. * Cannot tolerate vaginal examination either due to discomfort, pain or history or traumatic experience

Contacts and Locations

Study Contact

Chensi Ouyang, MD
CONTACT
4076314010
chensi.ouyang@va.gov
Mario Castellanos, MD
CONTACT
4076314010
mario.castellanos@va.gov

Study Locations (Sites)

Orlando VA Medical Center
Orlando, Florida, 32827
United States

Collaborators and Investigators

Sponsor: Orlando VA Medical Center

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2021-10-27
Study Completion Date2024-08-01

Study Record Updates

Study Start Date2021-10-27
Study Completion Date2024-08-01

Terms related to this study

Keywords Provided by Researchers

  • photobiomodulation
  • pelvic floor physical therapy
  • chronic pelvic pain
  • spastic pelvic floor syndrome
  • levator ani syndrome
  • myalgia of pelvic floor

Additional Relevant MeSH Terms

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