EVALUATION OF TISSUE OXYGENATION SATURATION USING NIRS FOLLOWING PRFE

Jonathan A. Niezgoda, BS, CHWS, Sandeep Gopalakrishnan, PhD, MAPWCA, and Jeffrey A. Niezgoda, MD, FACHM, MAPWCA, CHWS

PRFE device (Provant Therapy, Regenesis Biomedical Inc, Scottsdale, AZ, USA) is a non-invasive device that delivers pulsed electromagnetic energy to superficial soft tissue in the radio frequency range of 27.12MHz.

One of the top priorities in the field of wound care is reducing inflammation and tissue edema, both of which have been correlated with increased tissue oxygenation and perfusion, as well as a reduction in associated pain. Pain management in patients with chronic wounds is typically achieved by using medications such as opioids and NSAIDS, both of which have negative side effects and cannot be used without close supervision. An alternative is pulsed Radio Frequency Energy (PRFE) therapy, which is a medical technology designed to deliver pulsed, shortwave radiofrequency energy to superficial soft tissue using a portable, non-invasive treatment device.

Near-infrared spectroscopy (NIRS) can be used to evaluate tissue oxygen saturation (StO2) and perfusion following PRFE therapy. This therapy is used to decrease tissue inflammation and edema, while enhancing StO2 by delivering pulsed electromagnetic energy to superficial soft tissue. This case presentation demonstrates the effect of PRFE on enhancement of StO2 in three cases, confirmed by SnapshotNIR.

Methods: Three patients underwent PRFE therapy to one lower extremity while the other extremity was used as a control. Immediately prior to the therapy the limbs were imaged with SnapshotNIR to assess initial tissue oxygenation. The patients were seated with the target limbs elevated for 30 minutes as they underwent treatment. Once the therapy was completed, the patients were imaged a second time to determine the effect of the PRFE had on their StO2. Another image was captured 1-2 hours after the completion of the treatment to determine the duration of the effect observed in prior imaging.

CASE 1

A 36-year-old male with history of venous insufficiency and lower extremity leg ulcers. Images show a significant increase in StO2 following a single 30-minute PRFE treatment. The improvement in StO2 was found to persist for 45 minutes post-therapy

Case 1. Lower limb anterior and lateral leg StO2 images.

CASE 2

A 60-year-old female with history of Reynaud’s Disease received a single 30-minute PRFE treatment. Images show a significant increase in StO2 and the improvement in StO2 persisted for 45 minutes post-therapy.

Case 2. Dorsal and lateral foot StO2 images.

case 3

A healthy 21-year-old female showed slight augmentation in StO2 following a 30-minute PRFE treatment. This increase is noted to persist for 45 minutes post therapy.

Case 3. Dorsal and lateral foot StO2 images.

IMPACT OF SNAPSHOTNIR

Investigations into the mechanisms of PRFE have found that rapid changes in gene expression occur in cultured cells following PRFE treatment, including genes involved in inflammation and the endogenous opioid pathway (1, 2). PRFE has shown promise in vitro of producing anti-inflammatory and analgesic effects. Several clinical studies have reported benefit using PRFE therapy for pain relief, including relief of postoperative pain and chronic wound pain (3, 4).

Combining NIRS tracking with PRFE therapy, the changes in lower extremity StO2 were investigated over time. Enhancement of StO2 was observed following PRFE therapy in this series of patients. Therapies, such as PRFE, that activate the endogenous anti-inflammatory and anti-nociceptive pathways are being pursued as alternatives to the use of oral medications, due to their lack of systematic load and limited side effects. This study is the first to demonstrate enhancement of StO2 using SnapshotNIR following PRFE therapy.


References:

  1. Moffett J, Griffin NE, Ritz MC, George FR. Pulsed radio frequency energy field treatment of cells in culture results in increased expression of genes involved in the inflammation phase of lower extremity diabetic wound healing. J Diabetic Foot Complications 2010;2(3):57-64.

  2. Moffett J, Kubat NJ, Griffin NE, Ritz MC, George FR. Pulsed radio frequency energy field treatment of cells in culture results in increased expression of genes involved in angiogenesis and tissue remodeling during wound healing. J Diabetic Foot Complications 2011;3(2):30-39.

  3. Niezgoda JA, Hardin ST, Kubat N, Acompanado JA. The Management of Intractable Pain with Adjuvant Pulsed Electromagnetic Field Therapy.  PUBLISHED, May 2014, ADVANCES IN SKIN AND WOUND CARE (Adv Skin Wound Care. 2014 May: 27(5), 205-209).

  4. Foley-Nolan D, Barry C, Coughlan RJ, O'Connor P, Roden D. Pulsed high frequency (27MHz) electromagnetic therapy for persistent neck pain. A double blind, placebo-controlled study of 20 patients. Orthopedics Apr 1990;13(4):445-451.

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EVALUATION OF ENHANCED STO2 & PERFUSION USING NIRS WITH A NOVEL LOWER EXTREMITY THERAPEUTIC VASCULAR DEVICE

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SNAPSHOTNIR MONITORS A COMPLETE HEALING OF A LOWER LEG ULCERATION TO AVOID LOWER LIMB AMPUTATION