Near Infrared Imaging for Pelvic Pain
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial aims to find better ways to diagnose and treat myofascial pelvic pain, which causes ongoing pelvic discomfort and issues with bladder, bowel, and sexual functions. Researchers will use a special imaging technique called near-infrared spectroscopy (NIRS) to examine pelvic muscle function and assess whether different treatments improve pain and symptoms. Near Infrared Imaging will enhance the understanding of muscle function. Participants will be divided into three groups: one will learn relaxation exercises, another will receive specialized physical therapy, and the last will use a vaginal ointment designed to relax muscles. Women who have experienced pelvic pain for at least three months and have muscle tenderness in the pelvic area might be a good fit for this trial. As an unphased trial, this study offers participants the opportunity to contribute to groundbreaking research that could lead to better diagnosis and treatment options for myofascial pelvic pain.
Do I have to stop taking my current medications for the trial?
The trial protocol does not specify if you need to stop taking your current medications. However, you must refrain from starting any new treatments that could affect your pain during the study period.
What prior data suggests that near-infrared imaging is safe for measuring pelvic floor muscle function?
Earlier research has shown that near-infrared imaging is safe. Medical professionals often use it to observe blood flow and oxygen levels in tissues without causing harm. One study demonstrated that this method can prevent accidental injuries during surgery by better visualizing blood vessels, confirming its safety.
The medication in this study is applied inside the vagina and contains diazepam and baclofen. The FDA has approved both drugs for other uses. Diazepam commonly treats muscle spasms and anxiety, while baclofen helps relax muscles. Previous studies with these medications have shown they are generally well-tolerated at prescribed doses. However, some individuals might experience mild side effects like sleepiness or dizziness.
Overall, the available data suggest that the treatments under study are safe and generally well-tolerated.12345Why are researchers excited about this trial?
Researchers are excited about the potential of near infrared imaging for pelvic pain because it offers a non-invasive way to visualize and understand the underlying causes of pain in real time. Unlike current treatments that primarily focus on symptom management, like medication or physical therapy, this imaging technique could help tailor treatments by providing clearer insights into what's happening inside the body. By enhancing diagnostic accuracy, near infrared imaging could lead to more personalized and effective treatment plans, improving outcomes for patients with pelvic pain.
What evidence suggests that this trial's treatments could be effective for myofascial pelvic pain?
Research has shown that near-infrared imaging can help manage chronic pelvic pain. One study found that women with this condition experienced less pain after using red and near-infrared light therapy. This therapy reduces swelling and boosts cell energy. Another study confirmed that this imaging method is safe and has been successfully used to guide treatments for similar conditions. In this trial, researchers are evaluating near-infrared imaging for its potential to improve the diagnosis and treatment of pelvic pain by providing clear insights into muscle function.15678
Are You a Good Fit for This Trial?
This trial is for adult women who have had pelvic pain for at least three months and show tenderness in their pelvic floor muscles during an exam. Participants must be able to attend four study visits over six months.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Baseline Assessment
Participants complete questionnaires, undergo pelvic examinations, and have NIRS imaging performed
Treatment
Participants receive assigned treatment: education with relaxation exercises, pelvic floor physical therapy, or vaginal medication
Follow-up
Participants are monitored for safety and effectiveness after treatment, including repeat assessments and NIRS imaging
What Are the Treatments Tested in This Trial?
Interventions
- Near Infrared Imaging
Trial Overview
The study uses a noninvasive imaging method called near-infrared spectroscopy (NIRS) to measure how well the pelvic floor muscles work before and after treatment. Participants are randomly assigned to education with relaxation, physical therapy, or vaginal medication.
How Is the Trial Designed?
3
Treatment groups
Experimental Treatment
Active Control
Placebo Group
Compounded intravaginal diazepam 0.5% and baclofen 0.4% ointment. Participants receive a compounded intravaginal ointment containing diazepam (0.5%) and baclofen (0.4%) to promote pelvic floor muscle relaxation. Medication is initiated nightly and may be titrated up to three times daily based on symptom response and tolerability.
Pelvic floor physical therapy with myofascial release will be performed by a designated female physical therapist who is a Board-Certified Clinical Specialist in Women's Health Physical Therapy. The methods and approaches used will be at the discretion of the therapist, based on an individual assessment of symptoms and detailed pelvic floor assessment.
Education and Generalized Relaxation. Patients are educated about myofascial pelvic pain and given a home course of non-specific relaxation exercises administered via a virtual intervention of five 5-10 min videos.
Find a Clinic Near You
Who Is Running the Clinical Trial?
University of California, Los Angeles
Lead Sponsor
National Center for Complementary and Integrative Health (NCCIH)
Collaborator
Citations
Transvaginal Photobiomodulation Improves Pain in ...
The primary study outcome was change in overall pelvic pain level from baseline compared to after 8 treatments (data collected at clinic visit #9).
Short-term outcomes of near-infrared imaging using ... - PMC
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Comfortable Sitting: RLT for Chronic Pelvic Pain Management
A study in Lasers in Medical Science found significant pain reduction in women with chronic pelvic pain after a course of red and near-infrared ...
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springermedicine.com
springermedicine.com/endometriosis/interventional-radiology/interventional-radiology-treatments-to-address-chronic-pelvic-pa/50237082Interventional Radiology Treatments to Address Chronic ...
Emerging IR techniques show promise for treating endometriosis and PICs. This review discusses patient presentation, diagnostic evaluation, and ...
Evaluation of a novel deep tissue transvaginal near-infrared ...
A novel near-infrared laser system has been commercialized for the treatment of myofascial pelvic pain in women (SoLá Therapy, UroShape, LLC).
Measuring Pelvic Floor Muscle Fitness Before and After ...
The study uses a novel, transvaginal near-infrared spectroscopy (NIRS) system to assess pelvic floor muscle oxygenation, hemodynamics, and recovery during ...
Near-Infrared Imaging With Indocyanine Green for the ...
Two hundred and seven (86.2%) lesions out of the overall 240 were visualized with WL imaging, and 200 were confirmed to be pathologic (true positive for WL).
Near-Infrared Vascular Imaging and ...
Secondary outcome measures included number of PIV attempts and pain scores as reported. This may lead to increased patient safety (preventing iatrogenic ...
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