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Scientific Research

CLINICAL STUDIES: VIDEOS

Daily Home Electrical Stimulation as an Adjunctive Therapy to Accelerate Wound Healing

– Authored by Brian D. Lepow, DPM; and Alejandro Zulbaran, MD

Brian D. Lepow, DPM and Alejandro Zulbaran, MD present their study, “Effectiveness of Daily Home Electrical Stimulation as an Adjunctive Therapy to Accelerate Wound Healing in People with Diabetic Foot Ulcer – a Double-blinded Randomized Controlled Trail,” at SAWC Virtual 2020. This study was awarded 1st place in the Oral Abstract category. In addition to Drs. Lepow and Zulbaran, fellow coauthors of this study include Hector Elizondo, MD; Akashdeep Singh, DPM; Jeffry Ross, DPM; and Bijan Najafi, PhD.

Video presentation of the Baylor College of Medicine study titled “Effectiveness of Lower Extremity Electrical Stimulation to Improve Skin Perfusion” by Alejandro Zulbaran, Brian Lepow, Catherine Park, Bijan Najafi.

CLINICAL RESEARCH PAPERS

Promotion of Wound Healing in Diabetic Foot Ulceration with the Tennant BioModulator and Tennant BioTransducer
– Researched by Lilia Feria NMD, Anthony Pinazza NMD Joe TiIchen’s NMD

“Diabetic foot ulceration is major source of morbidity with an estimated prevalence of 9- 25% among the estimated 30.3 million people with diabetes in the United States (1-4). Approximately 5.0 per 1,000 people with diabetes will undergo limb amputation annually (5). As ulceration significantly amplifies risk of amputation, improvements to limb salvage efforts are needed.

Current best practices in the management diabetic foot wounds involve three major elements: regular monitoring, wound cleaning and dressing, and mechanical off-loading (6-7). These strategies focus on mitigation of factors that may inhibit wound healing. Estimated rates of wound healing are 1-2% per day with standard methods (8). While glucose control is standard in management of diabetes, significant evidence has not been found to correlate glucose control and wound healing (9). A large number of treatments undergoing evaluation focus on reducing risk of infection while waiting for wound closure but do not yield enhanced rates of closure. Hyperbaric oxygen therapy has shown some evidence of improving healing rates, but quality of data does not yet support generalized recommendations for this treatment (10). Other approaches to biochemically enhance biological processes at work in the wound have not provided evidence of improved rates of healing. Physical therapies such as microcurrent and pEMF have shown positive but limited evidence in small studies of improving rates of healing (11-12). 

Effectiveness of Daily Home Electrical Stimulation As An Adjunctive Therapy to Accelerate Wound Healing In People With Diabetic Foot Ulcer 

– A Double-Blinded Randomized control trial – 

By: Alejandro Zulbaran, Naima Rodriguez, Hector Elizondo, Anmol Momin, Jeffrey Ross, 

Miguel Montero-Baker, Brian Lepow, Joseph L. Mills, Bijan Najafi 

Division of Vascular Surgery and Endovascular Therapy, 

Michael E. DeBakey Department of Surgery

Diabetic foot Ulcers (DFUs) create a high expenditure for healthcare systems and could lead to limb loss. Electrical Stimulation (E-stim) is an alternative treatment option to speed up wound healing. The study’s aim is to evaluate whether home-based daily E-stim therapy can speed up wound healing. The hypothesis is that daily E-stim therapy would improve tissue oxygenation of DFUs, therefore accelerating the healing process.

The first RCT study examined feasibility and effectiveness of home-based E-stim therapy to improve wound healing. With over 90% self-adherence, the study suggests high perceived ease of use and benefit to wound healing among people with DFU’s. Our results revealed positive contribution of E-stim to improve tissue oxygen saturation, a key ingredient for wound healing.

Effectiveness of Lower Extremity Electrical Stimulation to Improve Skin Perfusion

Alejandro Zulbaran, Brian Lepow, Catherine Park, Bijan Najafi Division of Vascular Surgery and Endovascular Therapy, Michael E. DeBakey Department of Surgery

Severe Long-term Knee Pain and Limp Mitigated with BioTransducer

Case Study of Patient with Possible Ahlback Disease, Data Provided by Jarrah Ali Al-Tubaikh MD, Sabah Hospital, Kuwait City, Kuwait 

A 71-year-old diabetic patient with hepatitis C presented with a history of right knee osteoarthritis due to a fracture suffered 20 years ago. The patient came limping in to the radiology department to investigate his severe right-sided knee pain that hindered his gait.

Accelerate wound healing and increase perfusion potential

– Geoffrey C. Gurtner, MD, FACS (Stanford University), Lawrence Lavery, DPM,MPH, Brian D. Lepow, DPM

“Three US. medical centers are currently collaborating to evaluate the bio-electric neuromodulation device (FDA- cleared for pain relief) and asses its potential to increase perfusion in chronic wounds.

Treatment of Idiopathic Late Onset Cerebellar Ataxia A Case Study

– Tony Pinazza NMD, Jeffrey Langland PhD, Lilia Feria NMD, Joseph Tilchen

“This case represents the successful treatment of late onset cerebellar ataxia with Biomodulator therapy.  This treatment demonstrated the ability to improve muscle strength, coordination and ADL’s better than conventional treatment standards. 

X-Rays Show Structural Changes After Biomodulator Microcurrent Treatment
– Dr Jarrah Ali Al-Tubaikh, MD

“Since learning of the BioModulator microcurrent device for drug-free, non-invasive pain relief, Dr. Al-Tubaikh has used it with patients and co-workers at his hospital as well as with friends, all of whom suffer from severe unresolved pain symptoms. In two cases, he used the BioModulator with patients specifically referred to him because of severe back pain, as word of the “miracle” treatment spread. In each case, Dr. Tubaikh said he takes images before and after treatment to document changes that have taken place after BioModulator treatment. “It is hard to argue against radiological images because the evidence is clear; it is not placebo anymore.”

MRI Improvement in Necrotic Knee after use of BioModulator
Jarrah Ali Al-Tubaikh, MD

A 71-year-old diabetic, hepatitis-C positive patient presented with a history of right knee osteoarthritis resulting from a fracture that had occurred approximately 20 years ago. On October 24, 2014, the patient limped into the radiology department. The initial MRI images showed severe osteoarthritis, complete cartilage loss in the medial femoral condyle (the lower end of the thigh bone at the knee), osteoarthritic changes, and marked edema (swelling) in the medial femoral condyle, suspiciously like Ahlback’s disease. Ahlback’s disease is the result of vascular arterial insufficiency to the medial femoral condyle of the knee resulting in necrosis (death) and destruction of bone.1 Traditional treatments for Ahlback’s disease are bisphosphonates, a group of drugs that are used in the treatment of osteoporosis and bone malignancies, and/or surgery. Additionally, chronic infections with hepatitis C virus add to age-dependent bone loss and may contribute to lower bone strength in the elderly.

After discussing therapeutic options with the patient, which, in this case, were restricted due to advanced age and deteriorated health, the option of pulsed electromagnetic frequency therapy using Tennant’s Biomodulator with the biotransducer attachment was suggested. Beginning on November 3, 2014, the patient was treated daily for 30 to 45 minutes for one month. During the period of therapy, the patient reported reduction in pain and swelling of the knee and improved ability to walk normally. An MRI scan was repeated in December 2, 2014, to document any differences in the MRI image.

The MRI images showed almost 90% resolution of the medial femoral condyle edema and the normal bone marrow signal returned to almost 90% normal. The lack of significant changes in the tibia is simply because the position of the biotransducer probe was concentrated for the treatment period over the medial femoral condyle region, mainly, the focus of pain”

Anti-inflammatory Effects of Electronic Signal Treatment

Source: Odell, Robert H., MD, PhD, and Sorgnard, Richard E. PhD (2008)

Pain Physician, 11:891-907 Las Vegas. 

Summary: We postulate that pharmaceuticals have a tendency to overwhelm biosystems, a very unnatural progression as evidenced by the side effect profiles. EST works through biosystems and their controls. We have presented multiple mechanisms, most documented and one postulated, which demonstrate initial facilitation and then quick resolution of the inflammatory process to prevent it from leading to chronic inflammation and chronic pain. While complex, all concepts above fit together when taken into the context of signaling cAMP; however, the basic signaling mechanism could easily be the oscillo/torsional ionic action on cyclic AMP. Through this and the other mechanisms discussed, cellular derangements are returned to normal in optimum physiological time. 

A paradigm shift in our approach should begin soon. Many patients in chronic pain are simply being under treated for various reasons. Narcotic medications are being diverted in increasing numbers. Most importantly, a recent study on adverse drug events based on the FDA voluntary reporting system has found the death rate has increased out of proportion to the increase in the number of prescriptions written, and the greatest culprits are pain medications and immune modulating drugs. The authors emphasized that these findings “show that the existing system is not adequately protecting patients and underscores the importance of recent reports urging far-reaching legislative, policy and institutional changes.” One purpose of this paper is to get the pain management physician to start to think about modifying the therapeutic approach, which might begin by emphasizing the physics approach as well as the pharmacological approach. 

The following from Potter and Funk, written in 1917, still apply: “Success in electrotherapeutics depends on an adequate knowledge of physiology and pathology as related to the human body; on a mastery of the laws that govern electricity [physics]; on the possession of efficient apparatus, the achievement of good technique by practice and the good judgment to apply all these requirements … Electrotherapeutics is not a system to be used to the exclusion of other therapeutic measures, but is a worthy addition to any physician’s armamentarium …”  

Conclusion: While we believe additional studies involving the treatment of inflammatory processes with EST are important, there appears to be enough evidence to encourage the primary or adjuvant use of EST for inflammatory conditions and for the potential replacement of chemical steroids. EST and the evidence presented have placed us on a threshold of discovery; it is time to apply this knowledge in the clinical setting. The alternative role of EST will depend on the outcomes of well-conducted clinical trials which utilize this reasonable and safe approach. 

Bioelectricity and microcurrent therapy for tissue healing – a narrative review 

Source: Poltawski, L and Watson, T:Physical Therapy Reviews2009 VOL 14 NO 2 (105-114); School of Health and Emergency Professions, University of Hertfordshire, Hatfield, AL10 9AB, UK

Background: Microcurrent therapy (MCT) uses electric currents similar to those produced by the body during tissue healing. It may be a particularly beneficial where endogenous healing has failed.

Aim: To review evidence regarding microcurrent in tissue healing and the application of MCT.

Methods: All peer-reviewed studies concerning microcurrent and MCT were sought, and representative literature was synthesized to indicate the scope and weight of current evidence.

Results: Microcurrent appears to play a significant role in the healing process, and MCT can promote healing in a variety of bone and skin lesions. The evidence for other tissues is encouraging but presently scant. 

Summary: MCT may have unrealized potential in the treatment of dysfunctional tissue healing and deserves greater attention by researchers and clinicians. 

Conclusions: The evidence in support of MCT is convincing enough to justify its inclusion in the clinician’s repertoire for treatment of several examples of recalcitrant bone and skin lesions.

The use of acupuncture-like electrical stimulation for wound healing of lesions unresponsive to conventional treatment

Sumano H, Mateos G (1999): Am J Acupunct. Sep-Oct;9(5):42-5.
Source: Program of Physical Therapy, Marquette University, Milwaukee, Wis, USA. 

Abstract: Based on previous experimental evidence suggesting improved healing of wounds treated with electrical stimulation, we conducted a clinical trial with patients seeking alternative medicine after unsuccessful conventional medical treatment. Electricity was delivered in two forms: (1) For wounds with extensive loss of tissue and/or those that had failed to heal spontaneously, electrical stimulation was delivered via subcutaneously inserted needles surrounding the wound edges and applying a dose charge of 0.6 coulombs/cm2/day; (2) in second degree burn injuries, lesions were covered with gauze soaked in a 10% (w/v) sterile saline solution and the same dose of electricity was applied as for (1). Forty-four patients were treated with electrical stimulation of the skin; 34 in group (1) and 10 in group (2). Following electrostimulation in all patients in both groups healing proceeded in a thoroughly organized manner, almost regardless of the severity of the type of wound or burn treated. Advantages and limitations of this technique are discussed. PMID: 10513093 

Promotion of wound healing with electrical stimulation

Kloth LC, McCulloch JM (1996) Adv Wound Care., 27(1-2):5-14. Department of Physiology and Pharmacology, School of Veterinary Medicine, National Autonomous University of Mexico, Mexico City. 

Abstract: Clinicians involved in the conservative care of chronic wounds have many treatment interventions from which to choose, including debridement/irrigation, dressings, pressure-relieving devices, hyperbaric or topically applied oxygen, whirlpool/pulsed lavage, ultrasound, topical antibiotics, and cytokine growth factors. All except the last two interventions are physical treatments that create a wound-tissue environment conducive to healing.

Unfortunately, many chronic wounds heal very slowly, do not heal, or worsen despite the best efforts of caregivers to promote tissue repair. An intervention commonly used to treat chronic wounds, especially by physical therapists, is electrical stimulation (ES). 

The rationale for use of this method is based on the fact that the human body has an endogenous bioelectric system that enhances healing of bone fractures and soft-tissue wounds. When the body’s endogenous bioelectric system fails and cannot contribute to wound repair processes, therapeutic levels of electrical current may be delivered into the wound tissue from an external source. The external current may serve to mimic the failed natural bioelectric currents so that wound healing can proceed. Certain chemotaxic factors found in wound substrates contribute to tissue repair processes by attracting cells into the wound environment. Neutrophil, macrophage, fibroblast, and epidermal cells involved in wound repair carry either a positive or negative charge. When these cells are needed to contribute to autolysis, granulation tissue formation, anti-inflammatory activities, or epidermal resurfacing, ES may facilitate galvanotaxic attraction of these cells into the wound tissue and thereby accelerate healing. PMID: 9069747 

The Effect of Microcurrent Electrical Stimulation on the Foot Blood Circulation and Pain of Diabetic Neuropathy 

Park, RJ; Son, H; Kim, K et al. (2011) Journal of Physical Therapy Science (23)3:515-518
Source: Department of Physical Therapy, College of Rehabilitation Science, Daegu University, South Korea 

Purpose: This study was performed to investigate the effect of microcurrent electrical stimulation on the foot blood circulation and the degree of pain experienced by diabetes patients. Twenty nine patients with diabetic neuropathy over the age of 60 were randomly divided into an experimental (16 patients, 67.9 ± 8.0 years) and a control group (13 patients, 70.4 ± 4.4 years). 

Methods: Both groups walked on a treadmill at a comfortable pace for 50 min/day, 5 days/week for 4 weeks, and each participant’s body weight, body composition, and blood lipid were examined at the baseline and 4 weeks later. 

Results: The results show that the foot blood flow rate increment after the intervention was significantly different between the experimental group and the control group, and the VAS was also significantly different. 

Conclusion: Based on the study results, we consider that microcurrent electric stimulation of the foot may be helpful for preventing the pain and diabetic ulcers by increasing the foot blood circulation in diabetes patients. 

Electro-membrane microcurrent therapy reduces signs and symptoms of muscle damage 

Lambert MI, Marcus P, Burgess T, Noakes TD (2002). Med Sci Sports Exerc. Apr;34(4):602-7.
Source: MRC/UCT Research Unit for Exercise Science and Sports Medicine, P.O. Box 115, Newlands, South Africa. 

Purpose: Delayed onset muscle soreness (DOMS) occurs after unaccustomed physical activity or competitive sport, resulting in stiff, painful muscles with impaired function. Acustat electro-membrane microcurrent therapy has been used to treat postoperative pain and soft tissue injury; however, its efficacy in reducing symptoms of muscle damage is not known. 

Methods: Thirty healthy men were recruited for a double-blind, placebo-controlled trial. The muscles of their nondominant arms were damaged using an eccentric-exercise protocol. Subjects were then randomly assigned to treatment with either Acustat or a matching placebo membrane for 96 h and monitored for a total of 168 h. 

Results: Subjects in both groups experienced severe pain and swelling of the elbow flexors after the eccentric exercise. After 24 h, the elbow joint angle of the placebo group had increased significantly more than those in the Acustat group (13.7 +/- 8.9 degrees vs 7.5 +/- 5.5 degrees; placebo vs Acustat, P < 0.05), possibly as a consequence of the elbow flexor muscles shortening. For the first 48 h after exercise, maximum voluntary contraction of the elbow flexor muscles was significantly impaired in the placebo group by up to 25% (P < 0.05), whereas muscle function was unchanged in the Acustat group. Peak plasma creatine kinase activity was also lower in the Acustat group (peak = 777 +/- 1438 U.L-1) versus the placebo group (peak = 1918 +/- 2067 U.L-1; (P < 0.05). The membranes were well tolerated by the subjects in both groups without any adverse effects. 

Conclusion: These data show that treatment of muscle damage with Acustat electro-membrane microcurrent therapy reduces the severity of the symptoms. The mechanisms of action are unknown but are likely related to maintenance of intracellular Ca2+ homeostasis after muscle damaging exercise. PMID: 11932567 

Microcurrent therapy: a novel treatment method for chronic low back myofascial pain 

McMakin, Carolyn R, MA, DC. (2004) Journal of Bodywork and Movement Therapies. Apr(8)2:143–153
Source: Fibromyalgia and Myofascial Pain Clinic of Portland, 17214 SE Division Street, Portland, OR 97230, USA 

Abstract: Chronic low back pain associated with myofascial trigger point activity has been historically refractory to conventional treatment (Pain Research and Management 7 (2002) 81). In this case series study, an analysis of 22 patients with chronic low back pain, of 8.8 years average duration, is presented. Following treatment with frequency-specific microcurrent, a statistically significant 3.8-fold reduction in pain intensity was observed using a visual analog scale. This outcome was achieved over an average treatment period of 5.6 weeks and a visit frequency of one treatment per week. When pain chronicity exceeded 5 years, there was a trend toward increasing frequency of treatment required to achieve the same magnitude of pain relief. In 90% of these patients, other treatment modalities including drug therapy, chiropractic manipulation, physical therapy, naturopathic treatment and acupuncture had failed to produce equivalent benefits. The microcurrent treatment was the single factor contributing the most consistent difference in patient-reported pain relief. These results support the observation that rigorously designed clinical investigations are warranted. 

Acupuncture Treatment Reduced Phantom-Limb Pain and Sensation 

Medical Acupuncture
Volume 25, Number 1, 2013
Mary Ann Liebert, Inc.
DOI: 10.1089/acu.2012.0928 

Synopsis: This study reviewed current publications to determine if acupuncture therapy had been shown to have a positive effect on the symptoms of phantom-limb syndrome. Avazzia technology, especially combined with the Avazzia MEAD, can be used as a needleless form of acupuncture. 

Nerve Stimulation Cuts Down on Migraines 

By Crystal Phend, Senior Staff Writer, MedPage Today
Published: February 11, 2013
Reviewed by Robert Jasmer, MD; Associate Clinical Professor of Medicine, University of California, San Francisco and Dorothy Caputo, MA, BSN, RN, Nurse Planner 

Synopsis: A noninvasive device that electrically stimulates the trigeminal nerve prevented migraines for patients whose episodes could not be controlled by medication alone, a trial showed. The number of days with a migraine dropped significantly, by about two per month, in the supraorbital transcutaneous stimulation group, without a change in the sham control group, Jean Schoenen, MD, PhD, of Belgium’s Liège University, and colleagues found. 

Transcutaneous Electrical Nerve Stimulation for Chronic Postherpetic Neuralgia
– Malcolm R. Ing, MD

“Treatment of postherpetic neuralgia (PHN) remains a challenging problem for clinicians. Herpes zoster is a relatively common disease with an incidence of 5 per 1000 patients per year. Involvement of the ophthalmic branch of the trigeminal nerve occurs in about 20% of cases. The typical clinical presentation of ophthalmic zoster is blisters and inflammation of the skin supplied by the first division of the trigeminal nerve. If the pain and inflammation remains in the skin after one month with persisting neuropathic pain, it is termed chronic PHN.

The risk of developing PHN is highest with increasing age and presents a major public health issue. Many treatment modalities have been considered with limited success.  Side effects from medical treatment include nausea, sedation, postural hypotension, dizziness, and somnolence. Constipation and sedation from opioids make these drugs poorly tolerated in the elderly.

Biofeedback is a well accepted therapeutic treatment option. Electronic devices are often utilized in biofeedback therapy. Modern modification of these self-controlled electronic neuroadaptive regulation (SCENAR) devices, such as the Tennant BioModulator (TBM), have been granted a Food and Drug Administration class II designation to help with CPN.

97% of Terminal Cancer Patients Previously Had This Dental Procedure…….
– Joseph Mercola, MD

Do you have a chronic degenerative disease? If so, have you been told, “It’s all in your head?” Well, that might not be that far from the truth…The root cause of your illness may be in your mouth. There is a common dental procedure that nearly every dentist will tell you is completely safe, despite the fact that scientists have been warning of its dangers for more than 100 years.
Every day in the United States alone, 41,000 of these dental procedures are performed on patients who believe they are safely and permanently fixing their problem.

What is this dental procedure? The root canal. More than 25 million root canals are performed every year in this country.
Root-canaled teeth are essentially “dead” teeth that can become silent incubators for highly toxic anaerobic bacteria that can, under certain conditions, make their way into your bloodstream to cause a number of serious medical conditions—many not appearing until decades later.

Most of these toxic teeth feel and look fine for many years, which make their role in systemic disease even harder to trace back.
Sadly, the vast majority of dentists are oblivious to the serious potential health risks they are exposing their patients to, risks that persist for the rest of their patients’ lives. The American Dental Association claims root canals have been proven safe, but they have NO published data or actual research to substantiate this claim.”

Application of a BioModulator for Enhancing the Efficacy of Antibiotics Against Wound Pathogens

– Vanessa Marcel1, Hosan Kim, Ph.D.1, and Mina Izadjoo1, and Jerry Tennant, MD2

 

In this study we used a BioModulator technology* which generates microcurrent, electrical impulses that are transmitted by electrodes in the device through the skin to interface with the body’s internal peripheral nervous system for various therapeutic intervention. This technology is FDA approved for pain management. This research was focused on evaluation of the BioModulator and determine if synergistically enhances efficacy of antibiotics for treating wound infections. We studied the synergistic effect of the BioModulator and antibiotics by employing various testing parameters.”

Antimicrobial Efficacy Testing of a BioModulator Technology

– Hosan Kim, Ph.D. 1, Jerry Tennant, MD2, and Mina Izadjoo1

 

Due to the emergence of antibiotic and multi-drug resistant pathogens, there is a growing need for development of novel and effective antimicrobial therapeutics and devices. Infections have become the greatest threat to the life and recovery of the combat casualty who survives the immediate trauma of the insult. The Tennant BioModulators generates microcurrent, electrical impulses that are transmitted by electrodes in the device through the skin to interface with the body’s internal peripheral nervous system for various therapeutic intervention. This technology is FDA approved for pain management. Our Study was focused on further evaluation of the handheld Tennant BioModulators as an antimicrobial therapeutic device.”

A randomized trial comparing the Tennant BioModulator to transcutaneous electrical nerve stimulation and traditional Chinese acupuncture for the treatment of chronic pain in military service members

-Kimberly S. Peacock, Erika Stoerkel, Salvatore Libretto, Weimin Zhang, Alice Inman, Michael Schlicher, John D. Cowsar Jr., David Eddie and Joan Walter

“Background: The present investigation tested the efficacy of the Tennant BioModulator, a novel pain management intervention that uses biofeedback-modulated electrical stimulation, to reduce chronic pain and its psychosocial sequelae in a sample of current and former military service members. The Tennant BioModulator used on its most basic setting was compared to two commonly used, non-pharmacological pain treatments—traditional Chinese acupuncture and transcutaneous electrical nerve stimulation (TENS)—in a comparative efficacy, randomized, open-label trial.

Methods: Participants included 100 active duty and retired service men and women with chronic pain undergoing treatment at the Brooke Army Medical Center in Texas, USA, randomly assigned to receive six, weekly sessions of either Tennant BioModulator treatment, traditional Chinese acupuncture, or TENS, in addition to usual care. Recruitment was conducted between May 2010 to September 2013. Outcome measures were collected at intake, before and after each treatment session, and at a 1-month follow-up. Intent-to-treat analyses were used throughout, with mixed models used to investigate main effects of group, time, and group × time interactions with consideration given to quadratic effects. Outcomes measured included ratings of chronic pain, pain-related functional disability, and symptoms of post-traumatic stress disorder (PTSD) and depression.”

Past Study by the SCNM Research Department

 

SCNM residents are advancing the frontiers of medicine by turning scientific insights into treatments that improve patients’ lives.”

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