An interventional study of SoLá therapy and Pelvic floor physical therapy in Pelvic Pain, Levator Ani Syndrome and Spastic Pelvic Floor Syndrome, sponsored by Orlando VA Medical Center. Recruiting at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-07-03.
Sponsored by Orlando VA Medical Center · Not applicable, Interventional, and Treatment
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:
Background:
Myofascial pelvic pain (MFPP) is defined as pain in the pelvic floor muscles, the pelvic floor connective tissue, and the surrounding fascia. Standard treatment options of MFPP include pharmacotherapy and pelvic floor physical therapy (PT). In severe cases (approximately 25%) who are not responsive to therapy, pudendal blocks and trigger point injections (TPs) may be used to temporarily alleviate pain and improve function. However, these are more invasive and may require anesthesia. Photobiomodulation therapy (PBMT) delivered by a low-level laser emitter has recently emerged as a treatment option for musculoskeletal disorders such as neck and low back pain. In patients with vaginal musculoskeletal pain, PBMT is also thought to be effective with minimal side-effects. SoLá is low-level pelvic laser emitter / photobiomodulation device that has FDA approval for intravaginal use to specifically treat myofascial pelvic pain and chronic pelvic pain. Although it is FDA approved and thought to be effective and less invasive, photobiomodulation using SoLá has not been rigorously studied in randomized controlled trials (RCTs).
Study Aims:
The primary aim is to evaluate the efficacy of SoLá pelvic therapy by comparing reduction in overall pelvic pain between women who undergo 9 treatments of photobiomodulation with SoLá (approximately 1 treatment twice a week), compared to women who receive standard pelvic floor PT once a week for 8 weeks. The secondary aim is to compare dyspareunia, pain with sitting, and compliance with therapy between the two groups.
Study Design and Methods:
The investigators will conduct a RCT comparing overall pelvic pain (primary outcome), dyspareunia, and pain with sitting in women who receive PBMT with SoLá (group 1) vs. women who receive pelvic floor PT (group 2). Twenty-eight total participants will be randomized to either study group after providing informed consent. After enrollment, participants will be treated with 8 weekly treatments of pelvic PT or 9 treatments of SoLá (administered twice weekly). Patient outcomes will be evaluated at baseline (before treatment 1), midway through their treatment (before treatment 5 of SoLá and treatment 5 of PT), and at the end of their treatment (1-2 weeks after treatment 8 of PT/treatment 9 of SoLá and 3 months after treatment 8 of PT/treatment 9 of SoLá). Pain levels will be assessed using the Short Form McGill Pain Questionnaire (SF-MPQ) which assesses sensory and affective components of pain, Pain Interference Short Form which evaluates the effect of pain on quality of life, and pain severity on a 1-10cm Visual Analog Scale (VAS).
Anticipated Results:
The investigators hypothesize that women who undergo PBMT will demonstrate greater improvements in all pain outcomes when compared to pelvic floor PT.
375 studies on the registry are indexed under Pelvic Pain; 89 are open to participants now.
This study's planned enrollment of 28 is below the median of 60 across 277 interventional studies indexed under Pelvic Pain.
Browse Pelvic Pain studies →Orlando VA Medical Center is the lead sponsor of 2 studies on the registry; 1 is open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: SoLá therapy
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.
Other: Pelvic floor physical therapy
SoLá therapy is a photobiomodulation device that works by stimulating mitochondria, soothing tense muscles, and promotes healing.
Physical therapy is manual myofascial release, muscles stretches, and exercises designed to help myofascial pelvic pain
Pelvic Pain Intensity
Change pelvic pain intensity using a 0-10cm visual analog scale. High score means a worse outcome.
Time frame: 3 months post treatment
Intensity of Dyspareunia
Change in dyspareunia intensity using a 0-10cm visual analog scale. High score means a worse outcome.
Time frame: 3 months post treatment
Intensity of pain with sitting
Change in intensity of pain with sitting using a 0-10cm visual analog scale. High score means a worse outcome.
Time frame: 3 months post treatment
Pain interference
change in the score from the Pain Interference Short Form 8A PROMIS® (Patient-Reported Outcomes Measurement Information System) Health Organizations questionnaire. High score is associated with worse outcome.
Time frame: 3 months post treatment
Plan to share: No — Final data sets underlying publications resulting from the proposed research will not be shared outside VA, except as required under the Freedom of Information Act (FOIA).
Started Oct 2021 (actual). Primary completion is estimated for Feb 2024, 27 months after the start.
Of 110 non-industry interventional studies with no phase under Pelvic Pain, half reached primary completion within 17 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 30. This study's planned 27 months is above that.
Counting every sponsor, half of 114 studies reached it within 17 months; a quarter within 5 and three quarters within 30.
How these figures are worked out, and which studies are left out of them.
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Orlando VA Medical Center