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Excerpts: Clinical Studies on the Performance of Neuromuscular Stimulators

SOFT TISSUE INJURIES

“…Several studies have shown positive correlations between muscle strength, flexibility, and the frequency of low-back pain. Weak trunk musculature and decreased endurance have thereby come to be identified as significant risk factors in the development of occupational hack problems …” 1

“… electrical stimulation has been shown to increase the muscle strength of the lower extremities”1

“… electrical stimulation may be a valuable treatment in the early care of low-back pain patients in maintaining and increasing strength and endurance of back muscles when a more active exercise program is too painful to perform.” 1

“… Electrical stimulation, a passive modality of muscle strengthening, may be better tolerated than exercise for a patient with acute or subacute low-back pain. Electrical stimulation also has the added advantage of providing an anesthetic effect from the stimulation, which may also decrease pain while treatment is being administered. (see modality comparisons) It must be recognized that selective training with electrical stimulation or exercise, or a combination of both, can be used to obtain optimal clinical results. Electrical stimulation may, therefore, become a valuable treatment modality for patients with acute and subacute back pain before begi ng an exercise and conditioning program …”2

“. . . a positive correlation between strength capacity and the frequency of low-back pain …”2

” … subjects with recurrent back pain had weaker trunk muscles and diminished flexibility … “2

“… The goal of most rehabilitative programs is aimed at improving the trunk strength and the endurance of the low-back pain patient. Electrical stimulation has be shown to be effective in increasing the strength of the muscles of the lower extremities … ” 2

” … Electrical stimulation has been shown to be superior to exercise in postsurgical knee patients, …abates muscular atrophy …” 2 (see FDA indications)

” It appears that for electrical stimulation to be effective, the intensity of the stimulation must be close to a maximum voluntary contraction.. .” 1 (see the modality comparison)

“The necessity for the intensity of stimulation to be high indicates that for electrical stimulation to be beneficial, subjects must have substantial pain tolerance.” 1 (see the modality comparison)

“… The patients who received neuromuscular electrical stimulation had stronger quadriceps muscles and more normal gait patterns.. .”3

“… it is extremely difficult to teach a patient to perform co-contraction at an intensity sufficient to provide overload to the muscles …” 3

“… Neuromuscular electrical stimulation has been shown to improve the torque-generating capability of the quadriceps femoris after operations on the knee ligaments …” 3

“.. . neuromuscular electrical stimulation may be more effective in increasing isometric strength of these muscles than volitional co-contraction …” 3

“… Electrically elicited co-contraction has been shown to decrease strain on the graft and to increase strength of the periarticular muscles …” 3

“… increases in muscle strength caused by electrically elicited contractions will similarly improve gait …” 3

“… Treatment with neuromuscular electrical stimulation is clinic based, more labor intensive, and therefore more costly …” 3 (The Neuro Care™ is portable and can be used in the patient’s home).

“. .. neuromuscular stimulation was only used three times a week …” 3

“… Neuromuscular electrical stimulation may prevent what some investigators have termed ‘reamed disuse’ …”3

“… Electrically elicited muscle contraction may be better able to augment muscle strength in patients who have weakness …”3

“… Overall, the patients in the neuromuscular electrical stimulation group had a more normal gait pattern than did the patients in the volitional exercise group. The quadriceps femoris muscles were stronger, the temporal gait patterns were nearly normal, and the kinematics were more like those of the uninvolved knee. The knees of these patients were stronger in the eighth post-operative week than reported averages for such patients years after the operation. Our results suggest that the use of neuromuscular electrical stimulation translates, at least in the immediate postoperative period, not only into an increase in muscle strength but also into an improvement in the functional use of the muscles…” 3

” Electrical stimulation can be used to assist in gaining the initial degrees of motion for patients with frozen shoulder or shoulder-hand syndrome… 4

“… Because electrical stimulation generally is limited to one or two muscle groups, stimulation of muscles to achieve shoulder flexion or abduction beyond the 90-degree horizontal plane is specially difficult …” 4 (see FDA letter)

“…Electrical stimulation to increase the strength and power output of the posterior deltoid muscle can be used to augment traditional muscle strengthening programs.. .” 4

“…Electrical stimulation for the reduction of shoulder subluxation not only may prevent further joint separation, but also can provide normal glenohumeral alignment for the patient when assuming the upright position. Thus, maintaining normal joint alignment and counteracting the stretching of the shoulder capsule that is caused by gravity are advantages of such stimulation…” 4

“…We have found that chronic use of neuromuscular stimulation for shoulder subluxation management has been most successful for patients in supervised care settings where supportive individuals can assist the patient in maintaining appropriate electrode placement and skin care…”4

“…Electrical stimulation has been shown to be effective in aiding the recovery of quadriceps femoris muscle force production after anterior cruciate ligament reconstruction…”9

“…Portable stimulators are appealing because they are easy to use and are presumably less costly than the use of stimulators in clinics…” 9

“…Advantage of cost-effectiveness of home-based regimens using portable electrical stimulators…”9

“…Subjects were able to achieve contractile forces averaging approximately 50% of the involved muscles…”9

“…Perhaps there are portable stimulators that are capable of evoking more electrically elicited force…”9

“…Recovery is positively correlated to contraction intensity when using electrical stimulation to strengthen the quadriceps femoris muscles…” 9

“. . .Mechanical difficulty is demonstrated by a patient’s inability to actively extend the knee to the point of passive extension…resulting diminished range of motion (ROM) at the knee…”10

“…Patients are indeed incapable of volitionally increasing their knee extensor output…”10

“…Electrical stimulation has been used successfully in increasing bath static and dynamic muscle torque. Thus, it offers a means by which patients can improve their muscle force output without having to perform volitional muscular contractions…” 10

“…The introduction of electrical stimulation therapy during the rehabilitative phase may in fact accelerate functional rehabilitation, resulting in an earlier patient discharge. This, in effect, returns the patient more quickly to normal active status at potentially reduced costs. . . “(10)

“…Clearly,…, electrical stimulation is effective in expediting recovery from surgery, as evidenced by a more rapid patient return to active daily living. Secondarily, reduced hospital stay may decrease the overall cost of patient care, contributing further benefit to the patient. ..”10

“. . The newest hope for aching backs, flabby stomachs and weak knees does sound like something out of science fiction. It’s called electrical stimulation (EMS), and it entails zapping a muscle with electricity to strengthen it. Once reserved for rehabilitating atrophied muscles. EMS is now being used to treat more subtle structural problems as well, since a therapist can direct the electrical current to areas of weakened muscle-such as the lower back-that ordinary exercise can ‘t reach…”11

“…lt takes an experienced hand to apply the right amount of current…Effective treatment with EMS takes some trial and error…”11

“…Scientists have shown that applying EMS several times a week will make a muscle stronger, even if the patient can no longer move it voluntarily…” 11

“…This strengthening technique is now standard treatment in rehabilitating weakened muscles after surgery.- It’s also being used to prevent muscle atrophy in arthritis patients, as well as those paralyzed from spinal cord injuries…”11

“…EMS can speed recovery from a variety of orthopedic injuries…” (11 )

“…dramatic improvement in paralyzed patients. EMS builds muscle mass, and that helps with circulation to the extremities, which in turn may prevent blood-clotting problems…” 11

“…Patients often get a psychological boost from the added muscle, too, because they feel stronger and look better…”11

“…More intriguing still is the prospect of using EMS to shore up postural weakness-an approach that may offer fresh hope to the 16 million Americans suffering from chronic back pain…” 11

“.. .very useful in helping patients improve their trunk muscle strength and endurance. ..”11

“…EMS can help elite athletes get past their training plateaus… ” 11

“…sessions are expensive, usually between $50 and $100 an hour…” 11 NOT the Neuro Care™!

“…EMS induced contractions can be painful…” 11

“… Lab studies have shown that electrical stimulation actually strengthens muscles more than an equivalent workout with weights. This suggests that EMS reaches muscle fibers that aren’t being contracted in normal exercise movements…” 11

“…Over the past eight years the field has come a long way, both in research and clinical applications…We’re still looking for the ideal stimulator-one that can strengthen without discomfort…”11

“… Electricity does more than just build muscles…EMS can even heal skin sores and bone fractures…”11

“…Most cuts, sores and broken bones heal by themselves. But certain chronic problems, such as bed sores and “nonunion” fractures, can linger for years…” 11

“…electric currents seem to speed up protein synthesis in damaged cells…” 11

“…many athletes also have some misconceptions regarding therapeutic modalities. Even amongst clinicians, it is difficult to find a consensus regarding treatment protocols. This can be frustrating for the clinicians, coach and athlete trying to accelerate a return to play…” 12

 

CIRCULATORY

“…The Iymphatic system serves a major bodily function, which is to provide a fluid return system from the tissues, restoring to the blood circulation both fluid and other substances, especially plasma protein that leaks out of the capillaries and cannot be reabsorbed directly back into the circulation. Thus, the Iymphatic system plays an important role in the overall homeostasis of body fluids… 7

“…Edema frequently accompanies venous leg ulcers…” 5

“…The presence of edema has several consequences. Edema promotes dermatitis and infection and may also impair wound healing. If lymphatic function is impaired, the cycle of edema, infection, and then fibrosis will cause further deterioration in lymph drainage. Lymphatic impairment may be an important component in the persistence of chronic venous leg ulcers and account for the difficulty of treating the “complicated leg ulcer” effectively…” 5

“…Swelling of the foot with clinical features indistinguishable from those Iymphodema often occurs in patients with chronic venous ulceration…” 5

“…Forty-five percent of ulcerated legs (in patients 65 years of age) were edematous. In the older group 33% of non-ulcerated limbs were swollen…”5

“…This decrease in function with age may be caused by changes in the transport capacity of the lymphatic system or by reduced muscle pump function…” 5

“…Thrombosis may result in deep venous incompetence and subfacial lymph transport is restricted in the post-thrombotic syndrome…”5

“…lymph pump is a major contributor to the outflow pressure-flow rate responses. .. 6

“…lymphatic vessels in many species including man are spontaneously active, and there is much evidence to suggest that this represents and important intrinsic mechanism for pumping lymph. . .”7

“…stimulation of the sympathetic chain increased lymph flow and lymphatic contraction frequency…” 7

“…increased lymph flow was not dependent upon an effect on blood vessels, thus supporting the notion that is was due to direct Iymphatic stimulation…” 7

“…The lymphatic system serves a major bodily function, which is to provide a fluid return system from the tissues, restoring to the blood circulation both fluid and other substances, especially plasma protein that leaks out of the capillaries and cannot be reabsorbed directly back into the circulation. Thus, the lymphatic system plays an important role in the overall homeostasis of body fluids. . .” 8

“…The active driving force is due to the intrinsic contractility of the lymph vessels…” 8

“…lymphatic smooth muscle tone seems to play a major role in the regulation of spontaneous contractions…”8

” The passive driving mechanisms are due to the compression and suction of lymph vessels resulting from extrinsic such as the muscle pump “8

ANSWER: These articles were written Ire 1993, the Neurocare™ 1000 4P/XP was registered with the FDA in August of 1993.

The Neurocare™ 1000 4P/XP is portable and can achieve muscle recruitment in the large muscle groups, deep muscle groups as well as the smaller muscle groups.

Because the Neurocare™ 1000 4P/XP is portable, the patient can give themselves treatments at home as often as prescribed. Thus allowing a more intense treatment program.

The Neurocare™ 1000 4P/XP is portable and approved for in-home use by the patient. Simple operation makes it very convenient for the user. Very cost-effective for the insurer and patient’s rehabilitation is accelerated because of more frequent treatments. Patient becomes a “participant in his/her own wellness program”.

The Neurocare™ 1000 4P/XP can be used at home and the family members can be instructed on the placement of the electrodes. As well as having specialized protocols with pictures to assist the patient at home.

The Neurocare™ 1000 4P/XP receives the deep contraction with little to no discomfort to the patient because the contraction is achieved primarily from voltage not amperage. Neurocare™ 1000 4P/XP has 1.2 milliamps and 340 volts.

The Neurocare™ 1000 4P/XP‘s four-lead model can be used with up to 16 pad placements, involving more muscle groups.

Neurocare™ 1000 4P/XP gets deep muscle contraction and also works the lymphatic vessels.

Neurocare™ 1000 4P/XP‘s indications include: Immediate Postsurgical stimulation of calf muscles to Prevent Venous Thrombosis.

Neurocare™ 1000 4P/XP‘s indications include: Reduction of Edema.

One of the indications listed for the Neurocare™ 1000 4P/XP is increased Range of Motion.

The Neurocare™ 1000 4P/XP has adapted effective parameters within the settings and the only thing that changes per patient or application is the intensity. This has taken the “guess work” out of the treatments, making it easier for the clinicians and for the patient when using at home.

The Neurocare™ 1000 4P/XP is proving to be THE IDEAL STIMULATOR!!!! Deep, strong muscle contractions with little to no discomfort.

It is amperage that causes pain. Most EMS units use 60 to 100 milliamps to achieve contractions, the Neurocare™ 1000 4P/XP uses 1.2 milliamps and uses voltage to achieve deep, strong contractions with little to no pain.

There is no “trial and error” when setting the Neurocare™ 1000 4P/XP, the necessary parameters are built in for optimal results, even with the patient doing the treatment in their home.

The Neurocare™ 1000 4P/XP is used at home, by the patient. It rents for $125 per week or $300 per month. Patients get well faster because they are able to have more frequent treatments.

Neurocare™ 1000 4P/XP‘s indications include: Prevention of Venous Thrombosis.

Neurocare™ 1000 4P/XP‘s indications include: Prevention or Retardation of Disuse Atrophy and Muscle Re-education.

Insurance cost is on the rise, and premiums are at a premium, so reduced recovery time and shortened hospital stays are a definite plus for both the insurance company and the patient.

Neurocare™ 1000 4P/XP/TENS/EMS COMPARED

There are many types of electrical muscle stimulators on the market and most of them basically the same. The TENS is separate from the EMS, since the indication for TENS is pain. Electrical muscle stimulation (EMS) units are therapeutic, working to control what causes the pain. As a narcotic and an anti-inflammatory can both be used to relieve pain, so can the Neurocare™ 1000 4P/XP (a unique EMS) and the TENS. Just as the two medicines relieve the pain through different neuro so do the two modalities. Therefore, the indications for the EMS is:

        1. Relaxation of muscle spasm
        2. Prevention or retardation of disuse atrophy
        3. Increasing local blood circulation
        4. Muscle re- education
        5. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
        6. Maintaining or increasing range of motion

These are the problems that cause most pain.

The various types of EMS units are

      1. Direct current, low-voltage
      2. Direct current, high-voltage
      3. Alternating current, low-voltage
      4. Alternating current, high-voltage
      5. Interferential
      6. H-wave
      7. Micro current

The micro current is 0-.05 milliamps at 0-1 volts. The others have an electrical output of 0-90 milliamps, achieving 0125 volts. Important to remember, voltage is in direct proportion to the amperage. Because of this direct proportion, lowering the amperage, in these units, will lower the voltage. All EMS units other than the Neurocare™ 1000 4P/XP work with this electrical relationship. 90 milliamps to 125 volts (90: 125, 10 milliamps to 35 volts (10:35. The H-wave is 0-35 milliamps and 0-35 volts (at 35 volts there is 35 milliamps). Muscle will contract at + 35 volts, however, the higher the voltage, the more recruitment of muscle fiber. It is the amperage part of electricity that is painful.

Manufacturers trying to make these units tolerable to the patient keep lowering the amperage which also lowers the voltage. At 10 miliamps:35 volts, the patient will only receive minimal muscle contraction (invoking the “fast twitch” or surface muscle only).

Ninety (90) milliamps are very painful and is usually used with paraplegics or quadriplegics, since they generally have no sensitivity. Even though, these units are only used at that level for short periods of time, 5-15 minutes, since this much output can burn the skin. At 90 milliamps muscle contraction is received at 125 volts. Since 90 milliamps is so painful, most treatments, with this type of equipment, is at 10 milliamps and + 35 volts. Even 10 milliamps is painful to most patients, so the treatment length is usually less than 20 minutes.

The Neuro Care™ 1000 has an AC design which allows the amperage/voltage proportion to be manipulated independent of each other. The Neurocare™ 1000 4P/XP has an output of 0-1.8 milliamps, receiving 0-340 volts. At 1.8 milliamp, the Neurocare™ 1000 4P/XP has a muscle contraction of 340 volts, with no pain to the patient. Other stimulators on the market with 10 milliamps achieve a muscle contraction of only 35 volts. Since the Neurocare™ 1000 4P/XP is less painful, the patient can have a longer treatment. The length of electro-therapy treatment is very important to accomplishing results. The Neurocare™ 1000 4P/XP is portable so the patient is able to have treatments closer together, even two or three times a day, as prescribed. To conclude, the other machines are 5 times the pain and only 10% of the power.

The Neuro Care™ uses a biphasic pyramidal wave with a frequency of 47 Hz. Duty cycles are fixed at 1.5 seconds on and 1.8 seconds off. There is no ramp time. These settings are preset with the intensity being the only variable. Thus allowing an accurate treatment to be administered by the patient or caregiver in the patient’s home. In medicine there is always a standard, but until the Neurocare™ 1000 4P/XP it has been impossible to standardize electro-therapy treatments. All other EMS units have variable settings, so there is no standardization of treatment between patients, even within the clinic setting. Neurocare™ 1000 4P/XP‘s standardization has allowed practitioners to treat more accurately and consistently when using electro-therapy.

The Neuro Care™ has combined high voltage, ultra low amperage, built-in parameters for ease and simplicity of use to achieve its remarkable effectiveness. The Neuro Care™ 1000 is not unique due to its packaging, number of outputs, or portability. These are all very desirable features – but are NOT unique. What separates the Neuro Care™ 1000 as being unique is the aforementioned extreme specificity of its electrical output and its preset parameters. As 104.5 and 105.1 on the radio dial are unique and specifically different and very far apart practically, so is the Neuro Care™ 1000 from other modalities.

We hope this clarification has been helpful and will assist you in providing state-of-the-art treatment for the patients who have access to this remarkable, new, technology.

BIBLIOGRAPHY

    1. The Journal of Sports Medicine and Physical Fitness. Vol. 32, No. 1, Pg 24, Article: “Strength training via high frequency electrical stimulation” by Nancy C. Rich, Dept. of Kinesiology, University of Illinois, Urbana, Ill.
    2. Spine, Vol. 12, No. 2, 1987, Article: “Normal Trunk Muscle Strength and endurance in Women and the Effect of Exercises and Electrical Stimulation”; by Neirl Kahanovitz, Md, Margareta Nordin, PhD, Rosemarie Verderame, RPT, Santiage Yabut, MD, Mohamad Pamianpour, MS, Kathy Viola, RPT, and Mike Mulvihill, Dr PH.
    3. The Journal of Bone and Joint Surgery, Incorporated, Vol. 73-A, No. 7 1991, Article: Electrical Stimulation of the Thigh Muscles After Reconstruction of the Anterior Cruciate Ligament” by Lynn Snyder-Mackler, PT, SC.D., SVI Ladin, PH.D, Anthony A. Schepsis, MD, and John C. Young, Ph. D, Boston University.
    4. Physical Therapy, Vol. 66, No. 12, Dec. 1986, Article: “Neuromuscular Electrical Stimulation of the Muscles Surrounding the Shoulder”, by Lucinda L. Baker and Karen Parker.
    5. Journal of the American Academy of Dermatology, Vol. 28, No. 4, April 1993, Article: “Abnormal Lymph Drainage in Patients with Chronic Venous Leg Ulcers” by R.H.. Bull, MA, MRCP, J.N..Gane, DCRR.. DNM..J.E.C. Evans, Msc, A.E.A. Joseph, Msc, FRCR, and P.S. Mortimer, MD, FRCP London, United Kingdom.
    6. The American physiological Society 0363-6119/93, article: “Effect of Outflow Pressure on Lymphatic Pumping in Vitro” by J. Eisenhoffer,, R.M.. Elias,, and M.G.. Johnston, University of Toronto, Toronto, Ontario, Canada.
    7. J. Physiol.. 1987. pp. 123-133, Article: “The Effect of Electrical Stimulation of the Sympathetic Chain on Peripheral Lymph Flow in the Anaesthetized Sheep” by J.G.. McGeown, N.G.. McHale and K.D. Thornbury (From the Department of Physiology, The Queen’s University of Belfast, 97 Lisburn Rd., Belfast BT9 7 BL).
    8. Biochemical Pharmacology, Vol. 45, No. 10, pp. 1941-1946, 1993, Article: “ Mechanisms for Regulating Tone in Lymphatic Vessels ” by Toshio Ohhashi.
    9. Physical Therapy, Vol. 74, No. 10, Oct. 1994, Article: “Use of Electrical Stimulation to Enhance Recovery of Quadriceps Femoris Muscle Force Production in Patients Following Anterior Druciate Ligament Reconstruction”, by Lynn Snyder-Mackler, Anthony Delitto, Susan W. Stralka, and Sherri L. Bailey.
    10. Arch Phys Med Rehabil. Vol. 75, sept. 1994, Article: ” Electrical Stimulation effect on extensor Lag and Length of Hospital Stay After Total Arthroplasty”, by Robert S. Gotlin, Do, Sid Hershkowitz, PT, Paul M. Juris, EdD, Erwin G. Gonzales, MD, W. Norman Scott, MD and John N. Install, MD copyright 1994 by the American Congress of Rehabilitation Medicine and the American Academy of Physical Medicine and Rehabilitation.
    11. American Health, July/August 1991, Article: “Plugged in Electrical Muscle Stimulation is Reaching Places Exercise Can’t”, by Kevin Cobb.
    12. Training and Conditioning, Article: ” Electric Healing”, by Brian Roberts.

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