.

Most important to clinicians was a perceived improvement in quality of life that was reported in 91% of respondents. These subjects were all initially unresponsive to their physician's prior treatments and unsatisfied with their results prior to this study.

Of secondary, but interesting importance was the finding that neuropathy patients whose primary symptom was numbness and tingling reported relief. Prescription pain meds have no palliative or therapeutic beneficial effects upon the non-pain symptoms of neuropathy.

Introduction – The Medical Need

Peripheral neuropathy (PN) is a progressive neurological disorder that affects 20 million Americans.  Nerve cells in many parts of the body can be affected but occurrence is most common in the feet.  Symptoms can be sensory and/or motor. 

Sensory symptoms include pain, numbness, tingling, burning, and impaired temperature and touch sensations. In severe cases the feet may be anesthetic.   Peripheral neuropathy patients characteristically exhibit objective sensory deficits (touch, temperature and vibratory sense). Motor changes are observed in more severe cases, and in segmental myelinopathy.

Motor symptoms in PN patients commonly include weakness or clumsy motion with a history of ataxic gait and falls.    Symptoms are disabling when they affect ability to walk or drive (ref2).

Current treatment of PN consists of pharmaceutical therapy with anti-epileptics, antidepressants, and opioids analgesics, but use of these medications has been limited by their many negative side effects (3-5). Additionally, these medications do nothing for numbness or restoration of muscle girth and/or function.

Quality of life may suffer from the neuropathic pain and numbness, or because of the side effects of the medications.  Thus, dissatisfied patients often seek other modalities of treatment.    Although earlier forms of electrical stimulation treatments have been tried, they work by temporarily blocking the nerves with a simple square wave at high voltage (100 volts) and frequency (100 HZ) to overwhelm the nerve, causing fibrillation, and thus inhibiting the ability of the nerve to re-polarize between impulses. 

The unique ReBuilder Neuropathy Treatment System, developed by ReBuilder Medical, Inc., is a method of dual electrical stimulation to stimulate nerves and muscles simultaneously. Thus the nerves are treated, and the muscles are re-educated simultaneously.  The ReBuilder also diagnostically analyzes the peripheral nerves waveforms in real time, and it delivers a compensating waveform to gently, and painlessly coax the nerves back to full function.  The ReBuilder stimulates at a lower frequency (7.83 HZ), lower voltage (1 to 50V), and rather than a square wave, it uses a complex waveform that duplicates the waveform that is found only in the peripheral nerve system.  Like noise canceling headphones, the ReBuilder administers a compensating waveform that results in a therapeutic restoration of nerve transmission function.

 

Discussion – The Technology

The ReBuilder Device:

The ReBuilder is registered with FDA as a 510K pre-amendment version of a combination of a TENS unit (transcutaneous electrical stimulator) and an EMS (electronic muscle stimulator).

The impulses are uniquely delivered in a variety of ways, depending on the patient’s unique situation, symptoms, and needs.  There are three primary ways to administer the impulses:

1. Split compartment footbath (the method used in this study)

2. conductive garments such as socks, gloves, or sleeves (recent accessory)

3. transdermally with self adhesive pads directly adjacent to the area of discomfort.

In this study, the patients exclusively used the footbath method of administration because this was the only option available at the time.  The other options were developed at a later date to simplify the administration and make the treatments possible in bed at night.

In the footbath method, carbon rubber electrodes are placed in an electrically isolated split compartment footbath filled ankle deep with warm water.  An electrolyte (provided) is added to the water within the footbath to enhance the conductivity. The patient puts his feet into the footbath and then adjusts the battery powered device so that the device delivers a pleasant set of gentle impulses.  Many patients feel so relaxed that they reported falling asleep during the treatment.

 

Two Simultaneous Signals:

The ReBuilder’s signal has a unique waveform that imitates the natural waveform of a healthy peripheral nerve signal with a small amount of current under the curve and a relatively low transient voltage of 1 to 50 volts.  The resultant current is much below what is commonly produced by a traditional TENS unit.  The second, simultaneously delivered signal, is designed to stimulate adjacent muscle tissue and has a wider waveform with a larger amount of current under the curve and a much smaller voltage of 5-20 volts.  This signal causes the muscles nearby such as the feet, calves, thighs and buttocks to contract and relax in harmony with the stimulus.  The purpose of these muscle contractions is to stimulate the venous muscle pumps to increase local blood supply.

The combined electric signal is pulsed on and off at a frequency of 7.83 cycles per second to give the nerve cells time to repolarize.  This dual stimulation travels the ascending nerves from foot to foot, up one leg, across the nerve roots on the lower spine to the descending nerves of the contralateral leg and foot, thus treating the entire lower half of the body.

Another unique aspect of the ReBuilder lies in its biofeedback, real time, self-adjusting waveform analysis.  Just as the nerve signal to the heart has a distinct waveform or shape, enabling a cardiologist to diagnose abnormalities in that waveform, and the brainwaves display a character shape that enables the neurologist to diagnose a flat line for a deceased patient or a patient in seizure, the inventor of the ReBuilder David Phillips, PhD, discovered that the peripheral nerves have their own, characteristic waveform and peripheral neuropathy can be diagnosed by analyzing their waveforms.  Dr. Phillips noted that variations on the ascending waveform indicate numbness and variations in the descending waveform indicates pain.  The time period at the top of the waveform indicates the potency of the nerve cell to hold its signal long enough to pass it along the dendrites and axon. 

Utilizing this new information, the ReBuilder’s first signal is an exact copy of a healthy waveform and is sent from one foot to the other. The ReBuilder then goes silent and waits for an echo-like return signal sent similar to the automatic knee jerk reaction when a physician taps below the patella. The ReBuilder’s internal microprocessor analyzes the returned waveform for defects and creates a compensating waveform (similar to the Bose noise canceling headphones) to send as its second signal. This operation is performed 7.83 times per second. It is this ever-changing waveform analysis and creation that is said to be responsible for gently coaxing the dysfunctional nerve cell back to full potency. There is no other device we have found that has not only 2 separate signals overlaid on one another to stimulate both the nerves and the adjacent muscles, much less a device that self adapts to the patient’s particular bio-individuality and creates the exact waveform necessary to restore function and thus has a therapeutic value beyond the palliative control of pain. No other device that we know of offers hope for the patient suffering not of pain but of numbness.

 

 

 

 

Analysis – The Methodology:

The study population consisted of 551 individuals who purchased the ReBuilder device (with a money back guarantee) between December, 2002 and May, 2004 in response to an Internet advertisement about a new neuropathy treatment.  Those who returned the enclosed patient questionnaires were included this study. The questionnaire asked them to record their primary set of symptoms and to rate their discomfort from one to ten (ten being the worst) on the visual pain scale on a daily basis both before and after each treatment.  They reported the etiology of their peripheral neuropathy (if known), were queried about changes in their perceived quality of life, and were given a blank space in which to provide personal comments.  Quality of life was determined subjectivelyby respondents’ perception of pain at the beginning and end of the trial period, and changes in their pain scores were evaluated objectively by tabulating their 1 to 10 pain scores.

Statistical analyses were performed and included calculation of mean values and frequencies for categorical variables.  T-test was performed to determine significance of difference in pain scores at beginning and end of the trial and ANOVA was performed to compare the differences in pain score changes.

Results:  The average number of days of treatment was 9.9.  Nineteen records were excluded from the original group of 551 because of illegible data.  The remaining 532 records formed the basis of this report.  Etiology of the respondents’ neuropathy was stated to be:

• diabetic in 7% of respondents,

• impingement in 3%,

• toxic (chemo induced) or vascular 2%. 

• 88% were categorized as unknown or idiopathic.

This distribution of etiologies correlates well with neuropathy clinic observations. No demographics were provided.

Of the 532 total respondents,

• 99.58 reported some level of pain reduction at some point during their treatments.

• 93.43% reported an overall level of relief at the conclusion of the treatments.

• 91% of respondents reported an improvement in their quality of life

• Patients with pain (89%) reported an overall average 55% reduction in their pain score of 3.4+/-2.0 (p<0.0001). 

• 0% (no one) reported any negative side effects.

Most important to clinicians was a perceived improvement in quality of life that was reported in 91% of respondents. These subjects were all initially unresponsive to their physician's prior treatments and unsatisfied with their results prior to this study.

Explanation – The Science

Neural tissue is highly dependent on its microcirculation for its nutrition and health.  Thus, when the microcirculation is reduced by vasoconstriction or anatomic blockage, or poisoned by various toxins and/or abnormal metabolic states, hypoxia of the nerve tissue can occur.  The resulting peripheral neuropathy (PN) is a progressive clinical condition, which may lead to severe pain and disability. Both the location of the nerves (near the skin’s surface or deeper) and whether or not they are myelinated, determine the predominance of sensory or motor symptoms (10).  Initial numbness and tingling can eventually lead to pain. The inability for the patients to feel their feet can result in clumsiness and may progress to inability to walk or drive safely.

Chemotherapy and other neurotoxins like Agent Orange and certain artificial sweeteners can cause neuropathy.  Piriformis entrapment syndrome can put pressure on the sciatic nerve resulting in the characteristic feelings of numbness from the upper thigh to the great toe.

No matter what the cause, the nerve can respond in a similar way as muscle tissue when it is not used actively, like muscle atrophy observed with a casted limb.  Axonal atrophy results and until recently was considered to be permanent.  When the ends of the axons retrograde, the synaptic junction widens, which can inhibit effective nerve function.

One hypothesis of one of the causes of peripheral neuropathy is axonal atrophy which results in a “widening” of the synaptic junctions, particularly those in the nerve ganglions in the lower back. 

There is also considerable evidence of disruption of axonal transport in the most common polyneuropathies (17). This widening of the synapse and axonal transport dysfunction may make it more difficult for the electrical impulses to propagate and biochemical neurotransmitters to make the transition across synapses.  It may be that once a nerve is damaged, even temporarily, this axonal “shrinking” or atrophy can inhibit the smaller levels of electrical impulses both to and from the peripheral tissues.  [Like a heart defibrillator, the ReBuilder’s unique signal appears (18) to be able to re-energize these nerves, allowing the synaptic junction to extend closer from one sending axon to the other nerve’s receiving dendrite, thus restoring nerve function on a permanent basis.  The muscle stimulation portion of the ReBuilder’s unique waveform helps to increase local blood supply to feed these newly awakened nerve cells.

While the traditional TENS uses a high frequency square wave delivered at 90 to 100Hz to deliberately cause tetany, as in a muscle cell, by not allowing the nerve cell time to repolarize, the ReBuilder is said to be the exact opposite; instead of closing the nerve path, the ReBuilder opens the nerve path.

Although probably under-diagnosed, it is reported that PN occurs in at least 2 million Americans with an occurrence rate of several thousand cases yearly.  Because the incidence of diabetes is increasing, and because of the toxic lifestyle of inactivity, carbohydrate addiction, and skyrocketing obesity, PN is likely to join the list of conditions causing severe disability. 

Nerve conduction velocity (NCV) studies are commonly considered the gold standard of diagnosis and may be indicated in questionable cases.  However, even NCV may not detect very small fiber peripheral neuropathy and can be normal incases of obvious clinical presentation of symptoms and can be abnormal in cases where the patient does not present with peripheral neuropathy. Most clinicians, therefore, use the visual analog pain system to provide a relatively objective measurement of the patient’s pain.

There is no known cure for peripheral neuropathy and except in the case of diabetes mellitus, where tight glucose control has been reported to effect some minor improvement (12, 13), treatment has been directed largely at relieving symptoms rather than treating the underlying cause as the ReBuilder claims to do.    

Although a recent article suggested that only 50% of patients with PN have neuropathic pain almost all of the patients in our study complained of neuropathic pain and several other studies confirm an incidence of at least 80%.  The pain is extremely difficult to control.  Even though most studies of treatment for neuropathic pain and numbness have been performed in diabetic patients (3) the same medications are generally used in neuropathy of all etiologies because there are simply no other choices.   

Traditional treatment options for treating physicians include analgesics (up to and including morphine), anti-depressants, and antiepileptic drugs.  The only two drugs approved by the FDA for diabetic peripheral neuropathy are duloxitene (an antidepressant) and pregabalin (an anticonvulsant) (3).  Recently (2005-2019) synthetic cannabinoids and inhaled cannabis have been found to be useful in neuropathic pain (4, 5).  Part of their effect is to promote better sleep.

The role of electrical stimulation in the treatment of neuropathic pain is controversial (12)).  

In 2010 both Jin and Pieber reviewed the literature on electrical stimulation for treatment of neuropathic pain.   They each concluded that there was overall improvement in PN pain at twelve weeks of treatment, but no improvement in numbness.  Pieber noted that symptoms returned to baseline within 30 days of treatment cessation.  Most recently, in their evidence-based guideline study In Neurology, 2011, Bril and others concluded that “electrical stimulation is “probably” effective in lessening the pain of painful diabetic neuropathy and improving quality of life.”  Their conclusion was based on a single Class I (randomized prospective) study.  Because of the method of action of a common TENS (blocking the nerve signals rather than opening them like the ReBuilder), any relief would logically only be palliative.  Common TENS also requires wearing the device constantly, as opposed to the ReBuilder’s daily 30 minute treatment.

In our study, patients purchased the ReBuilder in desperation after 1) failure of medical treatment and 2) because they could not tolerate medication side effects, or 3) because they were told there was “nothing else that could be done for them" and they would have to “live with their pain.” 

After searching the Internet or hearing of the device by word of mouth, they purchased the ReBuilder and agreed to complete a follow up questionnaire within three months of purchase.    Compliance was high; at least 90% returned the questionnaire within three months of purchase Thus, although this study is retrospective, it was open label, driven by patient need, and thus compelling. 

Conclusion:

The ReBuilder neurostimulator is distinctly different from traditional TENS units, and from other TENS types of electrical stimulation in that it is designed to improved the microcirculation, re-polarize and re-educate the nerves to follow the correct pathways rather than to confuse and force tetany by over stimulating  the nerve fibers with an unnatural square wave at high frequencies.    The ReBuilder was also designed to be simple to use in the home setting.  Recent accessories and protocols include conductive stockings, gloves and sleeves for home use, thus further simplifying the treatment process by providing an alternative to the warm water footbath, which, for some patients, can be cumbersome.

We have found no other published study with this great a number of patients as in our report.  The power exerted by this large number cannot be understated. 

Furthermore, we have not been able to find any other report of dual electric stimulation.  We also found no other waveform based technology with dual stimulation.

This ReBuilder device turns out to be ideal for treating the symptoms of neuropathy stimulate the healing of the microcirculation and nerve tissue.  Our study is highly suggestive that the ReBuilder treatment is of benefit to almost all patients with PN, both in terms of relieving pain, reducing numbness, in improving quality of life and providing a dramatic therapeutic clinical outcome without drugs. 

Further studies of electrical stimulation with the ReBuilder and other emerging technologies are in order.  Not only must patients with PN be offered alternatives to current medical therapy, but it should be determined whether electrical therapy results in persistent relief, and whether or not it should be used on a continual basis.  Finally, prospective studies on the use of electrical therapy to prevent PN in high-risk patients, such as diabetics and cancer patients undergoing chemotherapy are necessary.

We recommend that clinicians treating the pain and numbness peripheral neuropathy utilize the ReBuilder.  Patient compliance is very high; it moves the patient toward self-reliance and dramatically increases their patient’s quality of life and thus satisfaction with the physician’s efforts.

 

Draft version 10/20/2011 Uncorrected pre-publication, without references.

 

 

Do you or a loved one suffer from peripheral neuropathy? The road to recovery STARTS with the ReBuilder™! The ReBuilder’s patented electrical signal device has been proven  94% effective in clinical studies in reducing or eliminating painful symptoms of neuropathy.

 

Peripheral Neuropathy Treatments