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Chronic Pelvic Pain and Our Data

Chronic pelvic pain conditions often overlap with nonpelvic pain disorders (eg, fibromyalgia, migraines) and non-pain comorbidities (eg, sleep, mood, cognitive impairment) to contribute to pain severity and disability. Musculoskeletal pain and dysfunction are found in 50% to 90% of patients with CPP. Although prevalence re- search is sparse, the frequency of CPP in the US is approximately 15% and it is twice as common in women as it is in men.1 In settings where women with CPP are routinely evaluated with a standardized pelvic examination, 50–90% also present with musculoskeletal pain.1-4 Myofascial pelvic pain (MFPP) and myofascial pelvic floor dysfunction are related terms used to describe musculoskeletal pelvic pain and spasm that can manifest as pain with sitting, intercourse, urination, defecation and physical activity, and is commonly associated with symptoms such as urinary urgency, frequency, constipation, sexual dysfunction or physical disability.5,6 Because of its complexity, CPP has few treatment options. Pelvic physical therapy (PT) is one of the primary treatments recommended for CPP, especially when CPP is accompanied by MFPP or myofascial pelvic floor dysfunction. However, a 2019 systematic review of PT interventions for CPP concluded that, due to heterogeneity and poor methodological quality, the evidence does not support the use of PT for the management of CPP.7

PBM uses non-ionizing light energy, in a non-thermal process, to affect the mitochondrial chromophore cytochrome c oxidase (COX). The NIR light triggers biochemical changes initiating a chain of intracellular chemical reactions.8 Nitric oxide (NO) is displaced from the mitochondria. NO is a mitochondrial waste product that is capable of binding to COX and displacing oxygen, especially in injured or hypoxic cells.9 NO is a powerful relaxer of both smooth and skeletal muscle, and it is also capable of reducing muscle pain and improving circulation to oxygen-deprived tissues.8,10,11 Additional benefits are believed to be secondary to activation of various transcription factors that result from mitochondrial stimulation as well as the modulation of reactive oxygen species.12 Unlike typical lasers that emit energy in cylindrical beams, the SoLá Pelvic Therapy Laser uses a proprietary fiber and spherical probe to emit energy as a diffuse orb.

Using HIPAA-compliant methods, our near-infrared treatment system collects data on every treatment, every day, on every patient. We have already performed over 5,000 treatments and collected more patient-reported outcome data than we have been able to identify for any other single pelvic pain treatment. This is data on every patient treated at every clinic in the U.S. We do not exclude anyone from our analyses. We are helping the majority of treated women. These women are seeing improvement in overall pain, pain with intercourse, sitting pain, standing pain, pain with urination, pain with BM, vulvar pain, and exercise-related pain. These analyses have been published in the peer reviewed medical literature summarized herein.

  1. Lamvu G, Carrillo J, Ouyang C, Rapkin A. Chronic Pelvic Pain in Women: A Review. JAMA. 2021;325(23):2381-2391.
  2. Fitzgerald CM, Neville CE, Mallinson T, Badillo SA, Hynes CK, Tu FF. Pelvic floor muscle examination in female chronic pelvic pain. J Reprod Med. 2011;56(3-4):117-122.
  3. Mieritz RM, Thorhauge K, Forman A, Mieritz HB, Hartvigsen J, Christensen HW. Musculoskeletal Dysfunctions in Patients With Chronic Pelvic Pain: A Preliminary Descriptive Survey. J Manipulative Physiol Ther. 2016;39(9):616-622.
  4. Sedighimehr N, Manshadi FD, Shokouhi N, Baghban AA. Pelvic musculoskeletal dysfunctions in women with and without chronic pelvic pain. J Bodyw Mov Ther. 2018;22(1):92-96.
  5. Bonder JH, Chi M, Rispoli L. Myofascial Pelvic Pain and Related Disorders. Phys Med Rehabil Clin N Am. 2017;28(3):501-515.
  6. Lamvu G, Carrillo J, Witzeman K, Alappattu M. Musculoskeletal Considerations in Female Patients with Chronic Pelvic Pain. Semin Reprod Med. 2018;36(2):107-115.
  7. Fuentes-Marquez P, Cabrera-Martos I, Valenza MC. Physiotherapy interventions for patients with chronic pelvic pain: A systematic review of the literature. Physiother Theory Pract. 2019;35(12):1131-1138.
  8. Cotler HB, Chow RT, Hamblin MR, Carroll J. The Use of Low Level Laser Therapy (LLLT) For Musculoskeletal Pain. MOJ Orthop Rheumatol. 2015;2(5).
  9. Brown GC. Nitric oxide regulates mitochondrial respiration and cell functions by inhibiting cytochrome oxidase. FEBS Lett. 1995;369(2-3):136-139.
  10. de Freitas LF, Hamblin MR. Proposed Mechanisms of Photobiomodulation or Low-Level Light Therapy. IEEE J Sel Top Quantum Electron. 2016;22(3).
  11. Hamblin MR. Mechanisms and applications of the anti-inflammatory effects of photobiomodulation. AIMS Biophys. 2017;4(3):337-361.
  12. Chung H, Dai T, Sharma SK, Huang YY, Carroll JD, Hamblin MR. The nuts and bolts of low-level laser (light) therapy. Ann Biomed Eng. 2012;40(2):516-533.

An observational cohort study of pelvic floor photobiomodulation for treatment of chronic pelvic pain

Neeraj Kohli1, Barry Jarnagin2, Angela R Stoehr3 & Georgine Lamvu4

1Department of Obstetrics & Gynecology, Harvard Medical School, Boston, MA 02115, USA
2Center for Pelvic Health, Franklin, TN 37067, USA
3Nurture Women’s Health, Frisco, TX 75035, USA
4Department of Clinical Sciences – Obstetrics & Gynecology, University of Central Florida College of Medicine, Orlando, FL 32827, USA

This peer-reviewed publication is a before-and-after secondary analysis of de-identified data, prospectively collected from 144 consecutively treated patients undergoing PBM therapy with a SoLa ́ Pelvic Therapy device in 13 geographically diverse gynecology practices (Northeast, Southwest, West, Southeast and Midwest). The effectiveness identified in this analysis is greater than one might anticipate from 12 weeks of transvaginal physical therapy. Although all subgroups demonstrated improvement, the responce was most dramatic among those with a prior diagnosis of pelvic floor myalgia or vaginismus.

Observational Cohort Study Abstract

Evaluation of a novel deep tissue transvaginal near-infrared laser and applicator in an ovine model

Ralph Zipper1 & Brian Pryor2

1UroShape, LLC, 200 S. Harbor City Blvd, Suite 401, Melbourne, FL 32901, USA
2Litecure, LLC, 101 Lukens Dr, STE A, New Castle, DE 19720, USA

This peer-reviewed publication represents the first-ever validation of the delivery of therapeutic photobiomodulation to the pelvis. This study provides evidence that the novel SoLá Pelvic Therapy Laser system is capable of delivering therapeutic near infrared energy to the tissues and organs of the pelvis and further identifies the minimum laser energy output required to achieve such an outcome.

Observational Cohort Study Abstract