Research Articles

Efficacy of microcurrent therapy for treatment of acute knee pain: A randomized double-blinded controlled clinical trial

Published online 2020 Oct 23

Daryl Lawson (1), Kevin H Lee (2), Hyun Bin Kang (2), Nan Yang (3), Tracy Llewellyn (3), Shozo Takamatsu (4)

Affiliations
(1) Department of Physical Therapy, Western Michigan University, Kalamazoo, MI, USA.
(2) Department of Statistics, Western Michigan University, Kalamazoo, MI, USA.
(3) Department of Physical Therapy, Elon University, Elon, NC, USA.
(4) OMRON Healthcare, Inc., Muko City, Kyoto, Japan.

Abstract
Objective: We would like to determine whether electrotherapy, specifically microcurrent therapy, increases function and decreases pain in people who have acute knee pain.

Design: Randomized, double-blinded, placebo-controlled clinical trial.

Setting: University laboratory and patient home.

Subjects: A total of 52 subjects (35 females and 17 males) with acute knee pain.

Intervention: Treatment group (n = 26) wore the active microcurrent therapy device at home for 3 hours per day for 4 weeks and the control group (n = 26) wore the placebo for 3 hours per day for 4 weeks.

Main measures: Numeric Pain Rating Scale (NPRS) and Short Form 12 (SF-12) health scale were used to measure the pain level and the functionality of the participants. Secondary assessments included musculoskeletal ultrasound imaging (MSK US) and Lower Extremity Functional Scale (LEFS).

Results: A total of 52 subjects completed the study; 26 in the treatment group and 26 in the control group. Microcurrent therapy significantly reduced pain over 4 weeks. Especially week three was significant (P < 0.01) after adjusting for the family-wise error rate. The analysis on SF-12 revealed those with microcurrent therapy showed an increasing trend in the improvement of physical function score until week three.

Conclusion: An active microcurrent therapy device decreased knee pain and increased function. Microcurrent therapy may be an alternative or used with a pharmacological approach for people with acute knee pain.

Source: NIH.GOV

Bone Changes Due To Pulses Of Direct Electric Microcurrent

Richez, Chamay and Bieler, U. of Geneva:Virchows Arch. Abt. A Path Anat. 357, 11-18 (1972)

Summary: 26 rabbits had platinum electrodes surgically implanted into the medullary cavities of their humerus bones. Microcurrent stimulation was applied at 50 and 250 uA, allowing pause periods of one second between one second treatment bursts. The scientists found that osteogenesis (bone growth) happened more around the cathode (negative polarity), and that slight tissue necrosis occurred around the anode. The tissues stimulated acted as capacitors, discharging 75% of the current absorbed during the rest periods. They concluded that pulsed current is superior to direct current for bone healing acceleration.

The Effects of Electric Currents on ATP Generation, Protein Synthesis, and Membrane Transport
Summary: Research shows that ATP (adenosine triphosphate) levels increase with the application of microcurrent and diminish with millicurrent (Cheng 1982). The increase of ATP peaked at 500 microamps and decreased rapidly at higher current levels. Cheng also observed that aminoisobutyric acid uptake increased dramatically beginning at 10 microamps and inhibitory effects began at 750 microamps. The uptake of aminoisobutyric acid which is essential for protein synthesis and membrane transport, showed an increase of 30 – 40%.

Mechanism

During electro stimulation, proton gradients are created across the mitochondrial membrane. The current produces a gradient when electrons at the cathode react with water to form hydroxyl ions while producing protons at the anodic side. As a result a proton and voltage gradient are established across the intervening tissues between the electrodes. The influence of the electrical field and the proton concentration difference produce a proton current that moves from anode to cathode. As the migrating protons cross the mitochondrial membrane-bound H+ATPase, ATP is formed. The increased ATP production stimulates amino acid transport, and these two factors both contribute to increased protein synthesis.
(Cheng, 1982)

Reduction With Subcontraction High-Voltage Stimulation (SC-HVS):

1. Restricts leakage of flourescien labeled dextran from the microvasculature by decreasing permeability to proteins. (Reed B, 1988), (Bettany JA, 1990)
2. When microcurrent is applied to traumatized tissue, charged proteins are put into motion and migration into the lymphatic channels is accelerated. The lymphatic channels osmotic pressure is thereby increased, hastening the absorption of fluid from the interstitial space. (Alon G, Domenico G., 1987)
3. The movement of charged proteins into the lymphatic channels is accentuated and the contraction of lymphatic smooth muscle is enhanced. Fluid drawn into the vessels by the oncotic force of albumin labeled with blue dye distended the lumen of the lymphatic vessel and caused a subsequent increase in the rate of lymphatic contraction. (Cook HA & Assoc., 1994)

In Vitro Growth of Bovine Articular Cartilage Chondrocytes in Various Capacitively Coupled Electrical Fields

Carl T. Brighton, Anthony S. Unger, and Jeffery L. Stambough Department of Orthopaedic Surgery, University of Pennsylvania School of Medicine, Philadelphia. Pennsylvania

Summary: Isolated articular cartilage chondrocytes from 1- to 3-week-old male Holstein calf knee joints were formed into pellets containing 4 x 106 isolated cells and were grown in tissue culture medium (minimum essential medium/NCTC 135) containing either 1 or 10% newborn calf serum (NBCS) in plastic Petri dishes in 5% CO2 and air at 37°C in saturation humidity. On the 4th postisolation day either [3~S]sulfate or [3H]thymidine was added to the medium, and the pellets were exposed for 24 h to capacitively coupled electrical fields (10, 100, 250, and 1,000 V peak-to-peak, 60 kHz, sine wave signals). Current Intensity: 37 uA cm\2 The pellets were then harvested, dialyzed, hydrolyzed, and assayed for DNA, protein, [35S]sulfate incorporation, and [3H]thymidine incorporation.
Results indicated that at 250 V peak-to-peak there was a statistically significant increase in [35S]sulfate in 1% NBCS and a statistically significant increase in [3H]thymidine in 10% NBCS. At potentials above, or below 250 V no changes were noted. Thus, articular cartilage chondrocytes grown in pellet form can be stimulated to increase glycosaminoglycan synthesis or to increase cell proliferation by an appropriate capacitively coupled electrical field. The importance of the serum concentration in the medium in evaluation of biosynthesis in vitro is noted.

Comparative Effects of Microcurrent Stimulation on EEG Spectrum and Correlation Dimension
M. Heffernan: Integrative and Behavioural Science, July-September, 1996, Vol. 31, #3
Summary: 30 subjects were selected for a study comparing the effects of microcurrent on smoothing of EEG measurements of the brain. Subjects were randomly assigned to three groups – microcurrent (100uA) applied to earloble, trapezius area of shoulder, and no stimulation. Electrodes were arranged so subjects could not tell which group they were in. Fast Fourier Transform (FFT) and correlation dimension from chaos analysis were used to measure results. The researcher found that microcurrent applied to the shoulders was markedly more effective in smoothing EEG patterns than earlobe or placebo. “This would represent a possible cost-effective alternative to neurofeedback in treating (anxiety and attention deficit disorders), by raising low regions in the FFT.”

Case 1.

An 85 year old female with severe OA of the knee had been kept awake at night with pain. Prior treatments with anti-inflammatories and cortisone provided temporary, short term relief. CellStim treatment consisted of an IFC arrangement of pads on the medial/ lateral line and inf/ sup poles of patella. Treatments began at 3 times a week and then diminished. After 14 treatments in 10 weeks at 30 Hz/ 300 uA x 10 minutes and .3 Hz/ 40 uA x 10 minutes. The pain reduction indicated 95 % improvement.

Case 2.

A 70 year old male with moderate OA of the knee reports on occasion for treatment of knee pain. Previous treatment with IFC gave some improvement for short term relief. 20 – 30 minute CellStim treatments at .3 Hz and 40 uA biphasic gave lasting (2 weeks – 1 month) of significant relief (90-95% improvement). Pad placement was the same as case 1.

Case 3.

A 70 year old female with chronic OA of the 1st MTP was treated on 3 occasions with Cellstim at .3 Hz at 30 uA biphasic once per week for 3 weeks. The joint was probed (using Qtip electrode probes) moving the probe location every 3 to 5 seconds. After 3 treatments the patient reported 90% improvement.

Chiropractic College … Canada

Treatment Of Osteoarthritis Of The Knee With Pulsed Electrical Stimulation

Thomas M. Zizic

Objective: The safety and effectiveness of pulsed electrical stimulation was evaluated for the treatment of osteoarthritis (OA) of the knee.

Methods: A multicenter, double blind, randomized, placebo controlled trial that enrolled 78 patients with OA of the knee incorporated 3 primary efficacy variables of patients’ pain, patients’ function, and physician global evaluation of patients’ condition, and 6 secondary variables that included duration of morning stiffness, range of motion, knee tenderness, joint swelling, joint circumference, and walking time. Measurements were recorded at baseline and during the 4 week treatment period. Results. Patients treated with the active devices showed significantly greater improvement than the placebo group for all primary efficacy variables in comparisons of mean change from baseline to the end of treatment (p <0.05). Improvement of > 50% from baseline was demonstrated in at least one primary efficacy variable in 50% of the active device group, in 2 variables in 32%, and in all 3 variables in 24%. In the placebo group improvement of > 50% occurred in 36% for one, 6% for 2, and 6% for 3 variables. Mean morning stiffness decreased 20 min in the active device group and increased 2 min in the placebo group (p <0.05). No statistically significant differences were observed for tenderness, swelling, or walking time.
Conclusion: The improvements in clinical measures for pain and function found in this study suggest that pulsed electrical stimulation is effective for treating OA of the knee.

Studies for long-term effects are warranted. (J Rheumatol 1995;22:1757-61)

Data Collection Study, Microcurrent Therapy Lynn A. Wallace, PT (1990)

94% of the 1531 patients experienced a reduction in pain during the first treatment.
No side effects or increase in symptoms were reported. The overall results were remarkably similar when comparing the first 200 / 400 and 800 cases to the final total of 1531 cases.
Pain reduction occurring after the patient left the clinic was not recorded as pain reduction during treatment.
Patients who discontinued their treatments after significant progress (i.e. pain decrease from 10 to 3) but, before reaching a pain free state, were recorded as failures.
Similarly, patients whose treatment was discontinued by their physician before reaching a pain free state were recorded as failures.
96% response in pain relief.
88% pain free within 10 treatments.
12 types of acute injuries tested, average pain free = 4 treatments.
Acute radiating cervical pain, average pain free = 3.5 treatments.
Acute lower back pain, average pain free = 4.5 treatments
The following list of criteria was followed:
Patients were asked to rate their pain on a subjective pain scale (0 to 10, with 10 being unbearable pain).
Decreases in pain that were achieved after patients left the clinic were not included.
Biphasic current was used almost exclusively (negative current was used on selected cases with referred spinal pain).
Electrode probes and pads were used.
Daily treatment was encouraged, therefore, the total treatments rendered represent approximately that many days of treatment.
Medication was not altered.
No other modalities (heat, ice, electricity, or mechanical traction) were used.
Instructions such as positioning and avoidance were presented during the first treatment.
Worker’s Compensation Injuries Study (283 patients)
Control group on conventional therapy (hot, cold packs, massage) avg. # of treatments for back to work =20.7
Microcurrent only: avg. # of treatments for back to work =8.7
Microcurrent and conventional therapy: avg. # of treatments back to work =8.6
Result: 237 % accelerated healing response

Bioelectricity is conducted through five main components that may be found in any vascularized part of the body.

1. Insulating walls of blood vessels

2. Conducting intravascular plasma

3. Insulating tissue matrix (possibly including lymph vessels)

4. Conducting interstitial fluid

5. Transcapillary electrical junctions for redox reactions

A relatively higher electrical resistance is present in the walls of large blood vessels and a relatively lower resistance in plasma and interstitial fluids, giving rise to a voltage gradient. The vessel walls in this bioelectrical circuit act as electrically conducting, insulating cables that carry plasma (the conducting media) and separate it from the surrounding conducting media (the interstitial fluid) except at its transcapillary junctions (the naturally occurring electrodes in the bioelectric circuit).
(Nordenstrom B.)

The capillary cell membranes act as naturally charged electrodes that allow ions to move through the cells via gates and vesicles. Additional ions flow between the cells through pores. This local ion flow stops when excess electrons cross enzyme bridges in the capillary walls, closing the pores and gates and thereby closing the local circuit. This occurrence creates a long distance bioelectrical circuit in which the ions flow. The capillary cell membranes, therefore appear to be the key component in switching from local ion flow across the capillary membranes to long distance ion flow down the capillary walls.

An accumulation of charge (excess electrons) can be generated by soft tissue injury or even normal muscle use. The accumulation of charge may constrict arterial capillaries, switching the current on. However, venous capillaries do not constrict in an electrical field; therefore, ions and charged cells (e.g. neutrophils) can migrate through the pores of a leaky venous capillary near the injury. Because the polarity of the electrical potential from an injury changes, charged cells and ions necessary for healing may ebb and flow as changes take place in the electrical insulation properties of the capillary membranes.

A direct current (DC) system operates within the nerve fiber similar to the way a semiconductor functions. In a semiconductor small amounts of electrical current are transmitted via positive and negative charges through a crystal lattice. When a stimulus such as trauma, amputation, anesthesia or microcurrent is applied to living tissue, the surface potentials change. Only two seconds after trauma is invoked, DC potentials progress up the neuraxis to the cranium. This activity suggests that a biologic model of a semiconductor system transmits data regarding injury and that the change in surface potential is a record of the injury data transmitted.

The DC semiconductor system is composed of Schwann cell sheaths in the periphery, satellite cells in the dorsal root ganglion, and glial cells in the CNS.
(Becker R.)

Calcium acts like a semiconductor thus is stimulated with biphasic as well as monophasic current. Traveling wave depolarization where a group of cells stimulate adjacent cells creates a current pathway allowing microcurrent to penetrate through the GSR. Greater effectiveness has been shown with higher voltages ie. +/- 37 volts.

The Treatment Of Retinal Diseases With Micro Current Stimulation And Nutritional Supplementation

Edward L. Paul, Jr., O.D., Ph.D.*

*Visiting Professor of Ophthalmology

Chairman, Department of Continuing Medical Education

St. Luke.s University School of Medicine

Abstract

From May 2001 to November 2002, 94 eyes diagnosed with typically untreatable retinal diseases including age-related macular degeneration, retinitis pigmentosa and Stargardt’s were treated with an integrated treatment protocol employing micro current electrical stimulation and nutritional supplementation. Overall, 68% showed a marked increase in vision function and visual acuity following therapy. The success rate in age-related macular degeneration was 72% (26 out of 36 eyes), in retinitis pigmentosa 53% (18 out of 34 eyes), and in Stargardt’s 83% (20 out of 24 eyes). The average level of improvement was 2-3 lines as measured using the Snellen eye chart.

Discussion

Micro Current Stimulation (MCS) therapy is a noninvasive procedure which involves stimulating the retina and nerve fibers with very low intensity electrical current using a FDA and CE Mark approved electrical stimulation device. The current is delivered in the micro Amp range at different electrical frequencies through electrodes applied over closed eyelids. The treatment causes no discomfort or pain and is administered for 12 minutes, twice each day. While a very effective form of treatment, MCS therapy is not a cure for retinal diseases and must be continued for the life of the patient. Overall, no side effects or adverse reactions related to this procedure have been observed.

It is theorized that MCS therapy works by increasing intracellular ATP (adenosine triphosphate) concentrations, enhancing protein synthesis, and stimulating the cells. Ability to absorb nutrients. Through these mechanisms, MCS therapy improves RPE (retinal pigment epithelium) efficiency and thereby may restore and/or improve retinal function.

ATP is synthesized in the mitochondria process known as the Kreb’s Cycle, the sequence of reactions in the mitochondria that complete the oxidation of glucose in respiration. Kroll and Guerrieri have shown that there are age related changes in mitochondrial metabolism resulting in a decrease of the ATP synthase activity in the retina with age.

Guerrieri has gone further to show functional and structural differences of the mitochondria F0F1 ATP synthase complex in aging rats. It is theorized that many retinal diseases, at least in part, are due to a decrease in mitochondria function and the subsequent decrease in intracellular ATP. This decrease in mitochondria function results from free radical damage and the mutation of mtDNA (mitochondria DNA). It is interesting to note the genetic link between ATP and retinal disease. ATPase (ATP Synthase) is an enzyme which catalyzes the synthesis of ATP. A genetic defect in the ATPase 6 Gene has now been implicated in retinitis pigmentosa.

In October 2001 the National Eye Institute, a division of the National Institutes of Health, published the Age-Related Eye Disease Study which stated unequivocally that nutritional supplementation is an effective therapy against macular degeneration. This study was based on a seven-year double-blind study conducted by the NEI at eleven medical centers across the United States. It is clear that proper nutritional support can help protect us from diminishing eyesight and degenerative ocular complications as we grow older.

In evaluating MCS therapy in the treatment of retinal disease, clinical testing has shown that nutritional supplementation serves as a synergistic catalyst in boosting the effectiveness of MCS therapy. Subsequently, nutritional supplementation is a critical part of the MCS therapy program. The formula used on the test subjects was identical to that used in the Age-Related Eye Disease Study with the addition of Lutein, Taurine, and DHA (DocosaHexanoic Acid).

In respect to the legal status of MCS therapy, the Food and Drug Administration does not regulate the practice of medicine, however they do regulate the sale of medical devices.

Before a medical device can be legally sold or used in the U.S., the person or company that wants to sell or use the device must seek approval from the FDA. To gain approval, they must present evidence that the device is reasonably safe and effective for a particular use. The devices used in MCS therapy are approved, however they were originally developed and approved for the symptomatic relief of chronic intractable pain and as an adjunctive treatment in the management of post-surgical traumatic pain problems. Once the FDA has approved a medical device, a doctor may decide to use that device for other indications if the doctor feels it is in the best interest of a patient. Subsequently, the use of an approved device for anything other than its FDA approved indication is called off-label. MCS therapy for the treatment of retinal disease is considered an off-label use.

At least twenty other studies have been published regarding electrical currents effectiveness in dealing with degenerative disease, tissue repair, and cell regeneration. Four other studies have been published specifically addressing MCS therapy’s effect on retinal disease.

The American Academy of Ophthalmology issued a position statement regarding micro current stimulation which states: …the overall rate of adverse effects from electrical stimulation appears to be low. In the study of AMD and micro current stimulation, there were no reported adverse side effects from the electrical stimulation . long-term studies with larger samples of patients, and adequate control groups compared to micro current stimulation are critical to establishing a base of evidence regarding effectiveness.

The author agrees with the Academy.s position and two double-masked, randomized, and multi-site clinical trials are planned. The first will be coordinated by the University of California, San Francisco Medical Center on the treatment of dry (non-exudative) agerelated macular degeneration (AMD). A second study will evaluate the effect of MCS therapy on a variety of retinal pathologies including Stargardt.s, retinitis pigmentosa, and the wet (exudative) form of AMD. However, since there is no harmful aspect to the treatment as it currently exists and there is no viable alternative to this treatment, the author feels that eye care professionals should not withhold this option from patients pending the results of the long-term studies.

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Ngok Cheng, M.D., Harry Van Hoof, M.D., Emmanuel Bockx, M.D., Michel J. Hoogmartens, M.D.*, Joseph C. Muler, M.D.*, Frans J. De Ducker, Ph.D.*, Willy M. Sansen, Ph.D.*, and William De Loecker, M.D. *University of Louvain, Belgium The Effects of Electrical Currents on ATP Generation, Protein Synthesis, and Membrane Transport; Clinical Orthopaedics and Related Research.

Presented to the:

International Society for Low-Vision Research and Rehabilitation (ISLRR)

Goteborg University, Faculty of Medicine, Goteborg, Sweden

Electrical Stimulation Of Tendon Healing In Vitro

Nessler and Mass, Clinical Orthopedics and Related Research, April 1987

Summary: 80 tendons from white rabbits were surgically transected and removed from the animals after being surgically repaired. They were divided into 4 groups of 20, and cultured with 10 of each group being electrically stimulated, and half not. A 1.4 volt direct current connected through a 150 kOhm resistor was used for stimulation, at a current of about 7 uA. It was found that currents any higher than this caused discoloration of the tendons. Healing was measured by proline uptake and bridging of the repair site by the epitenon.

Results: “a continuous direct current causes increased tendon cell activity within seven days and the increased activity may persist as long as 42 days.” The researchers suggested that externally applied microcurrents may be preferable in future studies.

Electrical Energy and Soft-Tissue Injury Healing Sportcare and Fitness
Stanish and Gunlaughson, Sept/Oct 1988

Summary: This article is a summary of research into tendon healing acceleration, including human injuries of the anterior cruciate ligament and the Achilles tendons: “While the results are subjective, the individuals in both groups appear to have returned to usual activities more quickly, and have greater mobility, than people treated more conventionally”.

Low-intensity Pulsed Galvanic Current and the Healing of Tenotomized Rat Achilles Tendons: Preliminary Report Using Load-to-Breaking measurements
Oweye, Spielholz and Nelson, Archives Physical Med Rehab, Vol. 68, July 1987

Summary: 60 rats were divided into three groups of 20. One was unstimulated, one group had their Achilles tendons stimulated with positive (anodal) current, and the third group’s tendons were stimulated with negative (cathodal) currents. A current of 75 microamps, at 10 Hz was used. Results: “The group treated with anodal current withstood significantly greater loads (p<0.001) than did either the group which healed normally (i.e. without stimulation) or the group treated with cathodal currents”.

Several independent clinical studies have been published in peer-reviewed journals, such as “Arch Phys Med Rehabil” and “Stroke”. Below you will find a number of these in summary and in photocopy. The studies show effectiveness of the technique compared to control groups using regular therapy, electrical stimulation or no treatment. Most of the studies included patients between 6 months and 14 years post-stroke, subjects were motivated and cognitively intact, and the findings were:

– The time since the stroke did not impact effectiveness.

– Results were independent of age, side and nature of stroke.

– Improvements were maintained long-term.

– Improvements were in form of improved strength, range-of-motion, reduced spasticity and tone, flexibility, and motor capability in general. Regular therapy and electrical stimulation was less than half as effective.

Electrical stimulation driving functional improvements and cortical changes in subjects with stroke

Teresa J. Kimberley, Scott M. Lewis, Edward J. Auerbach, Lisa L. Dorsey, Jeanne M. Lojovich and James R. Carey, University of Minnesota

Published November 15, 2003, in “Experimental Brain Research”.

Summary:

It has been proposed that somatosensory stimulation in the form of electromyographically triggered neuromuscular electrical stimulation (NMES) to the peripheral nerve can influence functional measures of motor performance in subjects with stroke and can additionally produce changes in cortical excitability.

Using a controlled, double-blind design, we studied the effects of intensive (60 h/3 weeks) treatment at home with NMES compared with a sham treatment, applied to the extensor muscles of the hemiplegic forearm to facilitate hand opening in 16 chronic stroke subjects. We investigated improvement in functional use of the hand and change in cortical activation as measured by functional magnetic resonance imaging (fMRI). Following treatment, subjects improved on measures of grasp and release of objects (Box and Block Test and Jebsen Taylor Hand Function Test [JTHFT]: small objects, stacking, heavy cans), isometric finger extension strength, and self-rated Motor Activity Log (MAL): Amount of Use and How Well score. The sham subjects did not improve on any grasp and release measure or self-rated scale, but did improve on isometric finger extension strength. Importantly, however, following crossover, these subjects improved further in the measure of strength, grasp and release (Box and Block [JTHFT]: page turning), and self-rated MAL: Amount of Use score and How Well score. Using fMRI and a finger-tracking task, an index of cortical intensity in the ipsilateral somatosensory cortex increased significantly from pre-test to post-test following treatment. Cortical activation, as measured by voxel count, did not change. These findings suggest that NMES may have an important role in stimulating cortical sensory areas allowing for improved motor function.

Techniques to Improve Function of the Arm and Hand in Chronic Hemiplegia

George H. Kraft, MD, Sally S. Fitts, Ph.D., Margaret C. Hammond, MD. Arch Phys Med Rehabil Vol 73, March 1992.

Summary:

We evaluated functional improvement in the upper limb of chronic (more than six months’ duration) stroke patients who received one of two electrical stimulation treatments, conventional treatment, or no treatment. Twenty-two right-handed patients were assigned to one of four groups studied for 12 months posttreatment. Subjects received (1) EMG-initiated electrical stimulation of wrist extensors (EMG-stim), (2) low-intensity electrical stimulation of wrist extensors combined with voluntary contractions (B/B), (3) proprioceptive neuromuscular facilitation (PNF) exercises, or (4) no treatment. Subjects were treated for three months. Before treatment, upon completion of treatment, and three and nine months after treatment, subjects were evaluated by th Fugl-Meyer (FM) poststroke motor recovery test and by grip strength. Subjects also attempted three Jebsen-Taylor hand function tests and a finger tapping test at the same evaluation sessions, but many were unable to complete these tests. During the course of treatment, FM scores of subjects receiving PNF improved 18%, B/B improved 25%, and EMG-stim improved 42%. The aggregate FM improvement of the treated groups was significant from pretreatment to posttreatment, and the improvement was maintained at three-months and nine-months follow-ups (all p<.005).the treated subjects’ improvement in grip strength was also maintained at both follow-ups (p, .10). In contrast, the control group showed no significant change in FM scores or grip strength. The four treated subjects who were able to perform the hand function tests and finger tapping at all four evaluations also improved on these tests. We conclude that chronic stroke patients can achieve and maintain functional improvements, especially by combining electrical stimulation techniques with voluntary effort. Chronic Motor Dysfunction After Stroke James Cauraugh, PhD; Kathye Light, PhD, PT; Sangbum Kim, MS; Mary Thigpen, PT, MHS; Andrea Behrman, PhD, PT. 2000 Recovering Wrist and Finger Extension by Electromyography-Triggered Neuromuscular Stimulation. Background and Purpose – After stroke, many individuals have chronic unilateral motor dysfunction in the upper extremity that severely limits their functional movement control. The purpose of this study was to determine the effect of electromyography-triggered neuromuscular electrical stimulation on the wrist and finger extension muscles in individuals who had a stroke >1 year earlier.

Methods – Eleven individuals volunteered to participate and were randomly assigned to either the electromyography-triggered neuromuscular stimulation experimental group (7subjects) or the control group (4 subjects). After completing a pretest involving 5 motor capability tests, the poststroke subjects completed 12 treatment sessions (30 minutes each) according to group assignments. Once the control subjects completed 12 sessions attempting wrist and finger extension without any external assistance and were posttested, they were then given 12 sessions of the rehabilitation treatment.

Results – The Box and Block test and the force-generation task (sustained muscular contraction) revealed significant findings (P<0.05). The experimental group moved significantly more blocks and displayed a higher isometric force impulse after the rehabilitation treatment. Conclusions – Two lines of evidence clearly support the use of the electromyography-triggered neuromuscular electrical stimulation treatment to rehabilitate wrist and finger extension movements of hemiparetic individuals > year after stroke. The treatment program decreased motor dysfunction and improved the motor capabilities in this group of poststroke individuals.

Electromyogram-Triggered Neuromuscular Stimulation for Improving the Arm Function of Acute stroke Survivors: A Randomized Pilot Study

Gerard Francisco, MD, Jon Chae, MD, ME, Harmeen Chawla, MD, Steven Kirshblum, MD, Richard Zorowitz, MD, Gerald Lewis, MS, PT, Shcone Pang, MS, OTR. Arch. Phys. Med. Rehabil 1998; 79:570-575

Objective: To assess the efficacy of electromyogram (EMG)-triggered neuromuscular stimulation (EMG-stim) in enhancing upper extremity motor and functional recovery of acute stroke survivors.

Design: A pilot randomized, single-blinded clinical trial.

Setting: Freestanding inpatient rehabilitation facility.

Patients: Nine subjects who were within 6 weeks of their first unifocal. nonhemorrhagic stroke were randomly assigned to either the EMG-stim (n=4) or control (n=5) group. All subjects had a detectable EMG signal (>5?V) from the surface of the paretic extensor carpi radialis and voluntary wrist of the paretic extensor carpi radialis and voluntary wrist extension in synergy or in isolation with muscle grade of <3/5.
Intervention: All subjects received two 30-minute sessions per say of wrist strengthening exercises with EMG-stim (experimental) or without (control) for the duration of their rehabilitation stay.

Main Outcome Measures: Upper extremity Fugl-Meyer motor assessment and the feeding, grooming, and upper body dressing items of the Functional Independence Measure (FIM) were assessed at study entry and at discharge.
Results: Subjects treated with EMG-stim exhibited significantly greater gains in Fugl-Meyer (27.0 vs 10.4; p=.05), and FIM (6.0 vs 3.4: p=.02) scores compared with controls.

Conclusion: Data suggest that EMG-stim enhances the arm function of acute stroke survivors

Electromyographically triggered electric muscle stimulation for chronic hemiplegia.

R.W. Fields, Arch. Phys. Med. Rehabil 1987 Jul;68(7):407-14.

Electromyographically triggered electric muscle stimulation (EMS) was evaluated in combination with conventional treatment in 69 consecutive postcerebrovascular accident outpatients whose onset of hemiplegia was four months to 14 years earlier. Six subjects initially exhibited no residual volitional activity in targeted muscles, and all patients had undergone conventional therapy with little or no functional recovery. Prescribed treatment (patient compliance was frequently substandard) involved several months of four to five sessions per week, focusing on wrist extension and/or ankle dorsiflexion initially, and often other movements later. During 30 to 300 movement attempts per session, EMG’s that exceeded a preset threshold triggered immediate stimulation to force movement completion. Over sessions, patients commonly realized substantially improved increases in voluntary EMG capabilities generally proportionate to the frequency of treatment sessions. Parallel improvements were also found for subjectively scaled functional measures of range-of-motion and ambulation. Motivation was important to success, but side and nature of stroke, age, and poststroke interval were not. Progress often far exceeded that of previous conventional therapy. Regarding mechanisms, impaired proprioceptive feedback is considered central to stroke-disrupted sensorimotor control. EMG-triggered EMS is intended to improve brain relearning by reinstating proprioceptive feedback time-locked to each attempted movement. Clinical results were consistent with this theory.

Mental Practice of Motor Skills used in poststroke Rehabilitation has Own Effects on Central Nervous Activation.
Weiss, Ellen Hansen, R. Rost, L. Beyer, F. Merten, Christa Nichelmann, and C. Zippel. Intern J. Neuroscience, 1994, Vol. 78, pp 1 57-166.
Summary:

In the last years it has been shown that the use of the EMG triggered electrical myostimulation (ETEM) brings good results in poststroke rehabilitation. It has been hypothesized that the relearning effects obtained by means of ETEM are due to the reinstatement of proprioceptive feedback. However, the technique is most powerful if imagination of motor acts (the so called mental practice) is used as an initial part of ETEM. Since mental practice in healthy people leads to central nervous activation processes as well as to an improvement of motor skills, we investigated the effects of mental practice alone on central nervous activity by means of EEG in stroke patients.
Twelve left-sided hemiplegic patients who underwent a specific poststroke rehabilitation treatment were requested to perform a simple arm movement sequence. In the following mental practice period the patients were requested to imagine the same sequence without any real movement. EEG background activity was recorded during baseline and imagination periods. After the calculation of z-transformed power values within the alpha and beta-1 band, differences between rest and imagination periods were evaluated for significance.
Stroke patients showed significant decreases of alpha as well as beta-1 power during mental practice in comparison to the rest period. These changes are similar to those obtained in healthy subjects. Central alpha power diminished only during imagination of the contralateral arm. This phenomenon as well as the decrease of beta-1 power in central derivation were also obtained during real motor performance and might indicate an activation of the sensorimotor cortex. In accordance with the hypothesis of internal feedback mechanisms, this activation is a necessary prerequisite for motor learning during mental practice.

We conclude that mental practice of motor skills might have own effects in poststroke rehabilitation.
Treatment of Hemiplegia by Means of Imagination-dependent EMG-triggered muscle stimulation.

Danz, S. Gutierrez-Lopez. Physikalische Medizin, Heft 1, 4. Jahrgang, Feb. 1994.

Summary:

The imagination of a movement elevates the electrical activity of paralyzed muscles. By means of a device Automove, this changed activity is used to generate low-frequency pulses which in turn are applied to induce a contraction of the spastic antagonist muscles. In this way the imagination-dependent muscle stimulation – triggered by EMG – circumvents the spastic movement patterns. The patient becomes able to regain forgotten movements by means of the method described.
During the acute phase after a stroke it was applicable in only one third of our patients (n=40). Another group consisted of out-patients (n=20). In 18 of these a functional improvement of the paralyzed arm was attained after treatment for six months.

Two Coupled Motor Recovery Protocols Are Better Than One

Electromyogram-Triggered Neuromusular Stimulation and Bilateral Movements
(Stroke. 2002;33:1589-1594)

James H. Cauraugh, PhD; Sangbum Kim, MS

Background and Purpose: Overcoming chronic hemiparesis from a cerebrovascular accident (CVA) can be challenging for many patiens, especially after the first 12 months after the CVA. With the use of established motor control theories, the present study investigated electromyogram (EMG)-triggered neuromuscular stimulation and bilateral coordination training.

Methods: Twenty-five CVA subjects volunteered to participate in this motor recovery protocol study. Subjects were randomly assigned to 1 of 3 groups: (1) coupled protocol of EMG-triggered stimulation and bilateral movement (n=10); (2) EMG-triggered stimulation and unilateral movement (n=10); or (3) control (n=5). all participants completed 6 hours of rehabilitation during a 2-week period according to group assignments. Motor capabilities of the wrist and fingers were evaluated on the basis of 3 categories of motor tasks in a pretest-posttest control group design.

Results: Significant findings for the (1) number of blocks moved in a functional task, (2) chronometric reaction times to initiate movements, and (3) sustained muscle contraction capability all favored the coupled bilateral movement training and EMG-triggered neuromuscular stimulation protocol group. In addition, the unilateral movement/ stimulation group exceeded the control group in the number of blocks moved and rapid onset of muscle contractions.

Conclusions: This new evidence is convincing in that subjects in the coupled protocol group were able to demonstrate enhanced voluntary motor control across 3 categories of tasks. Chronic hemiparesis decreased considerably in the wrist and fingers as CVA patients expanded their motor repertoire.

Scientific And Clinical Studies On Bio-Electrotherapy

In order to adequately explain how the WellnessPro works to relieve PAIN, it is appropriate to begin by considering certain fundamental aspects of living tissue.

The body is made up of a vast number of cells. In many ways, these cells act like tiny batteries, storing and releasing energy, doing their work of taking in nutrients, releasing waste products, repairing and reproducing themselves, etc. Each cell, like any battery, has a measurable electrical charge, which must be maintained in order to function properly.

Energy flows constantly between all cells throughout the electrical circuitry of the body. When damage or trauma occurs to living tissue, there is a disruption in the electrical capacity of the involved cells and after an initial surge, there occurs, a measurable decrease in the production and flow of energy through the electrical network of the involved tissues. This condition is generally accompanied by pain in the area and often results in the body’s inability to completely repair itself. Thus, lengthy rest periods and inactivity are often prescribed in order to attain eventual restoration of normal function. The WellnessPro treatments have been likened to putting a “jump start” on the dead battery of a car (Also known as The Gate Control Theory).

Studies have also shown that some electrotherapy technologies can positively effects the production of ATP, sodium pump effect and Krebs cycle of the cell, thus enhancing the cell’s ability to stimulate its regenerative, instead of a degenerative, phase.

In 1991, two research scientists, Dr. Erwin Neher and Dr. Bert Sackmann won the Nobel Prize in Physiology and Medicine by detecting electrical currents of a trillionth of an ampere in the membrane, or surface of a cell.

Additional research findings of other electrotherapy devices have shown increased range of motion, a decreased healing time and progressive wound healing through the use of Bio electrotherapy. Detailed studies are provided here.

Unlike the Wellness Pro, many TENS devices use outdated technologies producing tremendously inaccurate frequencies, with little to NO results for the patient.

The “Deep Pulse” technology microchips in the WellnessPro ensure that you are getting the best, most accurate delivery of frequency to the affected area possible.

Although there are various devices and applications of electrotherapy in modern medicine, The Wellness Pro 2010 is specifically designed as the most advanced device for pain control and injury trauma rehabilitation.

Experimental Studies Of Influences On Healing Process Of Mandibular Defect Stimulated By Microcurrent

Tomoya Ohno, Shikwa Gakuho, #82 1982

Summary: 50 uA current pulses were applied to one side of the jaws of a group of dogs with lesions in their jaws. The other side was untreated. The dogs were examined at periods of 3, 7, 14, 21, 28, 42 and 56 days.
Results: “It seems likely that direct microcurrent promotes normal bone formation within the defective area and accelerates the osseous healing process. Prolonged application of electrical stimulus promotes a remarkable bone remodeling mechanism.”
Trigger Point Identification and Treatment with Microcurrent
DuPont, The Journal of Craniomandibular Practice, October 1999, Vol. 17, #4

Summary: This article gives the author’s techniques for locating and stimulating trigger points (TP’s) using a microcurrent stimulator, specifically for the treatment of temporomandibular disorders. He states that electrical conductivity is highest over trigger points, and galvanic skin response (GSR) testing can be used to locate such points. He utilizes probe electrodes to treat small TP’s, and pad electrodes to treat larger ones. Probe treatment is delivered @ 0.3 Hz, 20 – 40 uA, with treatment time of 10 – 30 seconds per site. He suggests administering treatment in 24-48 intervals, and states that results should be seen within 2 – 3 treatments. He acknowledges that these protocols are not necessarily the best ones, but work well for his practice.

Clinical Comparative Study of Microcurrent Electrical Stimulation to Mid-Laser and Placebo Treatment in Degenerative Joint Disease of the Temporomandibular Joint
Bertolucci and Grey, Journal of Craniomandibular Practice, 1995

Summary: 48 patients were divided into three groups, some receiving placebo, some microcurrent and some laser to treat pain of TMJ syndrome. Both microcurrent and laser were found to be significantly more effective than placebo, with laser slightly more effective than microcurrent. The author acknowledges that lasers are not legally sold in the United States for this purpose, and that microcurrent’s easy accessibility makes it more practical for practitioners here.

Electrotherapy Provides Relief To Type 2 Patients With Neuropathy

1 July 1999

Electrotherapy provided pain relief to approximately 85 percent of patients with peripheral neuropathy. Peripheral neuropathy is a complication that afflicts greater than 36 percent of people with type 2 diabetes. Its symptoms include painful and burning sensations that affect the feet and ankles. Because there is a misunderstanding of peripheral neuropathy’s development, several different treatment regimens have been prescribed over the years to treat the accompanying discomfort.

According to the Spring 1999 issue of Diabetes Technologies and Therapeutics, independent studies were conducted to determine if electrical nerve stimulation through the skin could relieve neuropathy pain.
In the first single-blind study, 31 patients were randomly assigned to receive electrotherapy or placebo treatment. Both groups received a portable electrotherapy machine with electrodes, but the electrotherapy group received a functional and calibrated unit. The control group received an inactive unit. Patients were instructed to treat each of their lower extremities for 30 minutes daily for a four-week period. The patient’s degree of pain was evaluated on a scale of 0 to 5.

After four weeks, 38 percent of the patients receiving sham therapy reported improvements with their neuropathy pain. On the other hand, 83 percent of the patients receiving electrotherapy reported improvements. Their pain scores declined from 3.17 to 1.44.

In another study, 26 patients with peripheral neuropathy were evaluated to determine the effectiveness of combining electrotherapy with the antidepressant amitriptyline. All patients were initially prescribed 50 mg. of amitriptyline at bedtime for four weeks, and then their pain scores were evaluated. Twenty-three of the patients who still reported pain symptoms were assigned to continue amitriptyline with either electrotherapy or sham therapy for twelve additional weeks. After twelve weeks, 85 percent of the patients receiving amitriptyline and electrotherapy reported improvement, with pain scores falling from 3.2 to 1.4.

Researchers could not conclude how electrotherapy provides neuropathy pain relief to people with diabetes. They do, however, feel that electrotherapy is a safe, beneficial and noninvasive remedy that could also be combined with amitriptyline.

Wound Healing

Polarity reversal of microcurrent reinitiates wound repair processes following plateaus in healing. Blood coagulation and thrombosis occurs in the vessel beneath the anode but not beneath the cathode. When the polarity is reversed the cathode is capable of solubilizing the clot formed beneath the anode.

(Becker R. 1988)

Electrotherapy for Acceleration of Wound Healing: Low Intensity Direct Current

Carley and Wainapel, Archives of Physical Medicine and Rehabilitation, Vol. 66, July 1985

Summary: 30 hospital patients with non healing ulcers were divided into two groups, one treated with conventional wound dressings and one with microcurrent stimulation at 300-700 uA. The latter group was given two two hour stimulation periods per day. After six weeks of such treatments, the group treated with microcurrents showed a 150-250% faster healing rate , with stronger scar formation, less pain and lessened infection of the treated area.

Accelerated Healing of Skin Ulcers by Electrotherapy

Wolcott, Wheeler, Hardwicke, and Rowley Southern Medical Journal, July 1969.

Summary: Researchers applied microcurrent stimulation ranging from 200-800 uA to a wide variety of wounds, using negative polarity over the lesions in the initial phase, and then alternating positive and negative electrodes every three days. The treated group showed 200-350% faster healing rates than control, with stronger tensile strength of scar tissue and antibacterial effects in infected wounds in the treated group.

Use of Low Intensity Direct Current in Management Ischemic Skin Ulcers

Gault and Gatens: Physical Therapy, Vol. 56, #3, March 1976.

Summary: 100 patients with skin ulcers were treated with microcurrent stimulation; six of them had bacterial ulcers with one side used as controls. Stimulation of 200-800 uA was applied, with negative polarity used until infection cleared, and then polarity reversed. Patients had diagnosis ranging from quadriplegia, CVA, brain tumor, peripheral vascular disease, burns, diabetes, fracture, and amputation. The lesions with patients treated with currents showed approximately twice as fast a healing rate.
Effects of Electrical Microcurrents on Regeneration Processes in Skin Wounds

Sinitsyn, Razvozva, Ortop Travmatol Protez, Feb. 1986

Summary: 68 patients with post burn and post traumatic wounds underwent treatment constant and modulated microcurrent of negative polarity of 1-10 uA/cm2 over a period of 2-20 days. Although both groups showed accelerated regeneration, the modulated electric current group showed more prolonged and marked effect. Better survival of skin grafts was demonstrated compared with untreated patients.

Bacterial inhibition by electrical activation of percutaneous silver implants.
J.A. Spadaro, S.E. Chase, and D.A. Webster:Journal of Biomedical Materials Research, Vol. 20, 565-577 (1986)

Summary: Percutaneous silver wire implants were placed in rats, and the wounds inoculated with Staphylococcus aureus to test how much infection would spread. Microcurrent stimulation was passed through the wires, with + anodal current placed into implanted silver wire, and the – cathodal electrode placed on the rat’s belly as a ground. It was found that significant inhibition of infection occurred, with the most marked results at 20uA current level. “Metallic silver can be effectively and efficiently activated to elicit its anti-microbial activity by the application of microampere electrical current.”

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