What side effects are associated with this type of intervention?

Common treatments for pelvic pain, such as laser phototherapy, acupuncture, and photodynamic therapy, generally have a favorable safety profile but can have some side effects. Laser phototherapy may cause temporary redness, swelling, or discomfort at the treatment site. Acupuncture is generally safe but can occasionally lead to minor bruising, bleeding, or soreness at needle insertion points. Photodynamic therapy can result in localized pain, swelling, and photosensitivity, where the treated area becomes more sensitive to light. These side effects are typically mild and transient.

What prior FDA approvals exist?

The FDA has approved various treatments for pelvic pain, including pharmacologic options like hormonal therapies (e.g., norethindrone acetate) and non-pharmacologic treatments such as physical therapy. While photobiomodulation (light therapy) is being studied for its efficacy in reducing pelvic pain, there is no specific mention of FDA approval for this treatment modality in the provided context. Generally, treatments aim to reduce pain and improve function, with ongoing research exploring new methods like photobiomodulation.

What other types of research exist?

Promising novel alternatives to photobiomodulation for pelvic pain patients include: 1) EMG biofeedback-assisted relaxation, which has shown effectiveness in reducing chronic pain in cancer patients. 2) Mindfulness-based interventions, such as Mindfulness-Based Stress Reduction (MBSR), which have been investigated for pain management. 3) Botulinum toxin A injections, which have been used to manage bladder pain syndrome and may have applications in pelvic pain. 4) Guided imagery and progressive muscle relaxation, which have been effective in reducing pain in cancer patients.

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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

Must not have

Have an active infection of the bladder, vagina, vulva, or urethra

Have evidence of active vaginal trauma, ulcerations, erosions, or other evidence of vaginal and vulvar skin breakdown

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a special laser therapy called photobiomodulation to help female Veterans with chronic pelvic pain. The therapy uses a low-level laser to reduce pain and inflammation in the pelvic area. Researchers want to see if this new treatment works better than traditional physical therapy. Photobiomodulation (PBM), formerly known as low-level laser therapy, has been successfully used for its anti-inflammatory and pain-relieving properties in postoperative care.

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.

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.

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.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I have been diagnosed with MFPP.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have an active infection in my bladder or genital area.

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I have active issues with my vaginal or vulvar skin.

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I cannot undergo vaginal exams due to pain, discomfort, or past trauma.

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I am not on medications sensitive to heat or light.

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I have or might have early-stage cancer in my cervix, vagina, uterus, bladder, or vulva.

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I am currently experiencing vaginal bleeding.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post treatment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Pelvic Pain Intensity

Secondary study objectives

Intensity of Dyspareunia

Intensity of pain with sitting

Pain interference

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

0 / 8Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for pelvic pain include photobiomodulation, physical therapy, and various integrative therapies such as acupuncture and mindfulness-based practices. Photobiomodulation works by using specific wavelengths of light to stimulate cellular activity, reduce inflammation, and promote tissue healing. Physical therapy often involves exercises and manual techniques to improve muscle function and reduce pain. Integrative therapies aim to modulate pain perception and improve overall well-being through mind-body connections. Understanding these mechanisms is crucial for pelvic pain patients as it helps them make informed decisions about their treatment options, ensuring they choose therapies that align with their specific needs and conditions.

Low-Intensity Photobiomodulation Decreases Neuropathic Pain in Paw Ischemia-Reperfusion and Spared Nervus Ischiadicus Injury Experimental Models.