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Photobiomodulation for Chronic Pelvic Pain (PMPP Trial)
N/A
Recruiting
Research Sponsored by Orlando VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Age ≥ 18
Clinically diagnosed MFPP
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 3 months post treatment
Awards & highlights
PMPP Trial Summary
This trial will study if photobiomodulation or pelvic floor physical therapy can reduce chronic pelvic pain in female Veterans. Participants will be randomly assigned to receive either treatments to compare reduction in pain.
Who is the study for?
This trial is for female Veterans over 18 with diagnosed myofascial pelvic pain (MFPP) who speak English and can consent. They must not have had prior treatments for MFPP, be pregnant, take certain drugs, or have a history of specific cancers or active infections. Participants also agree to avoid other MFPP treatments for 3 months post-trial.Check my eligibility
What is being tested?
The study compares photobiomodulation therapy (9 sessions) against pelvic floor physical therapy (8 weekly sessions) in reducing pelvic pain. Women are randomly assigned to either treatment to see which is more effective and has better compliance.See study design
What are the potential side effects?
Potential side effects may include discomfort during the procedures, light sensitivity reactions due to SoLá therapy, and typical physical therapy-related muscle soreness.
PMPP Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am 18 years old or older.
Select...
I have been diagnosed with MFPP.
PMPP Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 3 months post treatment
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~3 months post treatment
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Pelvic Pain Intensity
Secondary outcome measures
Intensity of Dyspareunia
Intensity of pain with sitting
Pain interference
PMPP Trial Design
2Treatment groups
Active Control
Group I: Pelvic Floor Physical therapyActive Control1 Intervention
The participant will be treated with pelvic floor physical therapy once a week for 8 weeks. Physical therapy involves standard approach of manual therapy including trigger point release, soft tissue mobilization, stretching, biofeedback, breathing techniques, relaxation yoga, and therapeutic exercises.
Group II: PhotobiomodulationActive Control1 Intervention
The participant will be treated with intravaginal SoLá photobiomodulation therapy for a total of nine treatments (two treatments a week). Each treatment lasting 5 minutes.
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Who is running the clinical trial?
Orlando VA Medical CenterLead Sponsor
1 Previous Clinical Trials
86 Total Patients Enrolled
1 Trials studying Pelvic Pain
86 Patients Enrolled for Pelvic Pain
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have undergone physical therapy or SoLá therapy for pelvic pain.I am 18 years old or older.I have an active infection in my bladder or genital area.I have active issues with my vaginal or vulvar skin.I cannot undergo vaginal exams due to pain, discomfort, or past trauma.I have been diagnosed with MFPP.You are pregnant, as confirmed by a urine or blood test.I agree not to seek other treatments for my pelvic pain during and for 3 months after the trial.I am not on medications sensitive to heat or light.I have or might have early-stage cancer in my cervix, vagina, uterus, bladder, or vulva.I have decreased feeling in my vagina or rectum.I am currently experiencing vaginal bleeding.
Research Study Groups:
This trial has the following groups:- Group 1: Pelvic Floor Physical therapy
- Group 2: Photobiomodulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the patient count for this experiment?
"Affirmative. Information from clinicaltrials.gov suggests that this trial is currently enrolling participants, with the initial post occurring on October 27th 2021 and the most recent update made June 21st 2023. This research endeavor requires 28 people to be recruited at a single site."
Answered by AI
Is this research project accepting participants at the moment?
"According to the clinicaltrials.gov database, this research is presently open for enrolment and participants can expect an up-to-date experience. The project was posted on October 27th 2021 and has been consistently updated since then; with its last update occurring on June 21st 2023."
Answered by AI
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