Naturepulse™ administers "Software controlled Short voltage impulse Therapy". At the Molecular Biology level this therapy stimulates a local release of two cytokines, Interleukin 1-beta (IL-1β) and TNF-α. The consequence of this is the natural production of endogenous Vascular Endothelial Growth Factor (VEGF) and Nitric Oxide.
Releasing VEGF results in cellular repair, an anti-Inflammatory effect and activation of new micro-circulation. [See: Biological Effects of a Software-controlled Voltage Pulse Generator (PhyBack PBK-2C the original prototype of Naturepulse™) on the Release of Vascular Endothelial Growth Factor (VEGF) In Vivo International Journal of Experimental and Clinical Pathophysiology and Drug Research 2005].
Naturepulse™ has been developed by Globe.
The essential requirements which require clinical data support are:
Available clinical data is divided in two groups. The first group includes every talk given at national and international conferences, also published by medical companies. That data comes from day to day use of these devices among public institutions.
The second group includes articles published by speciality journals that relate to studies about Naturepulseâ¢. The technology has its origins from studies and research by the inventor, Lorenzo Piccone.
The sources for the first groups of data the following criteria were considered:
To choose sources for the second group of data we considered the first two criteria.
There are no other devices with the aim to stimulate a local release of VEGF using a non-invasive device. Other known methods are pharmacological (systemic) or invasive.
The relevant standard to which these notes refer is the: "UNI EN ISO 14155: 2012 : Clinical investigation of medical devices for human subjects"
Pietrogrande M., Fusi A., Pesenti B. â U.O. di Medicina, Policlinico San Marco di Zingonia, Università di Milano
This research opens up new ways for the treatment of Raynaudâs syndrome.
M. Pietrogrande, M. Meroni, A. Pendazzini, B. Pesenti
Results of a study that indicates a new way to treat occasional rheumatic conditions.
C. Angeletti, C. Guetti, L. Merola, A. Paladini, A. Piroli, F. Marinangeli, A. Ciccozzi, I. Marsili, G. Varrassi.
University of L'Aquila, Chair of Anaesthesiology and Reanimation Verona 2006 - Congresso Nazionale AISD (Italian Association for the Study of Pain) Premise: Professor Giustino Varrassi, Chair of Anaesthesiology and Reanimation at l'Università dell'Aquila, was also President of the EFIC (European Federation of IASP Chapters [EFIC] where IASP stands for International Association for the Study of Pain).
This is a particularly interesting "case report". What is known as "Failed Back Surgery Syndrome" is an induced condition (under the heading Failure of Surgery) which consists of a serious worsening of the patient's condition after the surgical procedure.
As another surgery could be even more dangerous, the availability of a non-invasive therapy can increase the quality of life of the patient significantly.
P. Properzi , A. Paladini, A. Piroli, F. Marinangeli, M.G. Cifone, G. Varrassi.
University of L'Aquila, Chair of Anaesthesiology and Reanimation
Verona 2006 - Congresso Nazionale AISD
This is not clinical research, but a molecular biology study. It could be considered a corollary of the research published in the "in vivo" journal.
Angeletti C., Palesse N.*, Guetti C., Noviello F., Ursini L., Piroli A., Marinangeli F., Ciccozzi A., Varrassi G. Chair of Anaesthesiology and Reanimation, University of L'Aquila - *U.O. Hospital of Neurology, San Salvatore Hospital of L'Aquila - V.A.Do. Volunteering for Homecare â L'Aquila. Roma 2008 â Italian Association for the Study of Pain Conference
Fibromyalgia cannot be considered a "rare" pathology, but it should be considered "less frequent". Currently there is no standard way to cure it. All four cases which were followed by Prof. Varrassi's team, indicated a net improvement in the quality of life of the patients and an interesting use of the equipment in therapy.
Authors: L ongo G.; Boccia M.T.Y.; Caraccio V.; Frasca M.G.; Di Bartolomei M.; Tudini C.; Veronesi M.C.; Tufaro P.; Lazzari M.
UNIVERSITY HOSPITAL, TOR VERGATA, U.O.S.D. PAIN MANAGEMENT CENTER (Dir. Prof. A. GATTI)
Roma 2008 - Congre sso Nazionale AISD
This "case report" has been very important because it showed that the therapy can be administered to patients intolerant of analgesics (i.e. Gabapentin).
Software controlled short voltage impulses generator - PBK-2C (Naturepulse™) : clinical experience
Roma - Angelicum - 8/10 maggio 2008
Authors: Gubernari M.; Boccia M.T.Y.; Santucci M.; Zorbo S.; Rocconi F.; Trenca I.; Manni C.; La Placa E.; Lazzari M.
UNIVERSITY HOSPITAL, TOR VERGATA, U.O.S.D. PAIN MANAGEMENT CENTER (Dir. Prof. A. GATTI)
This is a survey from a very large sample, extracted from all patients that are normally treated with the software controlled short voltage impulses therapy (as of today this number exceeds 10000). 257 patients are considered for the test, where 238 are suffering 11 different osteoarticular conditions and 19 different peripheral vascular diseases. All cases show a significant improvement of the conditions of the patients.
Silvi Marina (Teramo) - 28/30 May 2009
GATTI A., LONGO G., CECCOBELLI M., SANTUCCI M., ROCCONI F., GALLI C., CARACCIO V., BARBIERO P., LAZZARI M.
Institute of Anaesthesiology, Intensive Therapy and Pain Management Center â University of "Tor Vergata", Rome (Director: Prof. A. F. Sabato)
This is another "case report" which confirms results obtained the year before. However this case is different because diabetes is the cause of the peripheral vascular disease.
Silvi Marina (Teramo) - 28/30 May 2009
GATTI A., LONGO G., CARUCCI A., D'ERCOLE A., FRASCA M.G., DI PAOLO A., VERONESI M.C., MARTINI L., BARBIERO P., LAZZARI M.
University of Tor Vergata (Rome) - Chair of Anaesthesiology, Intensive Therapy and Pain Management Center (Director Prof. A. F. Sabato)
Another survey, with a sample of 304 patients, which confirms all the significant results of the previous year.
Silvi Marina (Teramo) - 28/30 May 2009
GATTI A., GUBERNARI M., D'ERCOLE A., SANTUCCI M., BOCCIA M.T.Y., TRENCA I., FRASCA M.G., LAZZARI M.
Institute of Anaesthesiology, Intensive Therapy and Pain Management Center - University of "Tor Vergata", Rome (Director: Prof. A. F. Sabato)
Survey with a sample of 52 patients. Once again the results are positive so we can say that this is a successful therapy against tension headaches, a very frequent condition with a large economic and social impact.
Ferrara, Sala Convegni CNA
19 September 2009
Gianni Mazzoni - University of Ferrara - Center of Biomedical Sports Studies
Marco Fogli - University of Ferrara - President of the Italian Volleyball Doctors Association
This is a traumatic disease caused by a non-frequent osteo-articular pathology. The authors gathered the applicability of the therapy on sports traumatology in general.
New Delhi, 22nd November 2009
Clinical and vascular results of PBK (Naturepulse™) Therapy in Neuroischemic Ulcer - A new evidence in Wound Healing.
Prof. Dr. José Luis Lázaro Martínez - Jefe Unidad Pie Diabético - Universidad Complutense de Madrid
Prof. Martinez described personally the effectiveness of the therapy in treating the peripheral vascular disease caused by the diabetes.
Rome, Catholic University of the Sacred Heart, 2010
BIOLOGICAL THERAPY FOR CONTINENCE RECOVERY IN PATIENTS PREVIOUSLY SUBMITTED TO RADICAL PROSTATECTOMY: EFFECT OF A NEW SOFTWARE CONTROLLED DEVICE (PHYBACK PBK-2C) (Naturepulse™) FOR PELVIC FLOOR REHABILITATION.
Debora Marchiori, Alessandro Bertaccini, Claudio Ferri, Giuseppe Martorana
Unit of Urology - Policlinico Sant'Orsola-Malpighi
This study describes that this therapy can be used in the field of urinary incontinence.
Debora Marchiori, Claudio Ferri, Alessandro Bertaccini, Giuseppe Martorana
Unit of Urology - Policlinico Sant'Orsola-Malpighi
Manni C., Malara G., De Meo B., Masucci L., Bellino R., Chidic O., Lazzari M.,
Again a survey that takes a sample of 1502 patients and continues the collection of clinical data as items in 7 and 9 of this document.
Divizia M., Lazzari M., Natoli S., Scordo G., Casali M., Dauri M.
Fondazione Policlinico Tor Vergata - HUB Medicina del Dolore - UOC Anaesthesia and Reanimation Director: Prof. Mario Dauri
Sample of 630 patients suffering from vascular or osteoarticular pain. The survey was completed during 2012 and 2014.
Farina S, Casarotto M, Benelle M, Tinazzi M, Fiaschi A, Goldoni M, Smania N.
Section of Rehabilitation Neurology, Department of Neurological and Vision Science, University of Verona, Verona, Italy.
This study reveals FREMS and TENS therapies are equivalent for short-term results treating myofascial pain. TENS is not effective if mid-term results are considered.
Barrella M, Toscano R, Goldoni M, Bevilacqua M.
Endocrine and Diabetes Unit, Ospedale L. Sacco, University of Milan, Milan, Italy.
This study shows the therapy can treat patients with motor neuron excitability disease.
Bevilacqua M, Dominguez LJ, Barrella M, Barbagallo M.
Endocrinology and Diabetes Unit and LORENZ Research Center, Department of Medicine, Luigi Sacco Hospital (Vialba)-University of Milan, Milan, Italy.
The local release of VEGF occurs with FREMS therapy and does not with other electrotherapies.
It also confirms the success of FREMS therapy in treating diabetic polyneuropathy.
Conti M, Peretti E, Cazzetta G, Galimberti G, Vermigli C, Pola R, Scionti L, Bosi E.
Department of Medicine, Diabetes and Endocrinology Unit, San Raffaele Scientific Institute and Vita-Salute San Raffaele University, Via Olgettina, 60, 20132 Milan, Italy.
This study demonstrated the enhancement of cutaneous microvascular flow in patients with diabetic neuropathy is visible just after 10 treatments and remains measurable in follow ups after four months.
Bocchi L, Evangelisti A, Barrella M, Scatizzi L, Bevilacqua M.
This study focuses on rationalising the biophysical benefits induced in microvascular flow in diabetic patients after FREMS therapy.
The data collected from these two different investigation flows as mentioned above, their comparison, the long period of time in which research and studies have occurred (11 years), the high number of patients treated (in Italy and abroad, with over 10000 patients treated at Tor Vergata's teaching university) and the wide variety of diseases successfully treated by this therapy, demonstrate that: