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
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
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:
Split compartment footbath (the method used
in this study)
conductive garments such as socks, gloves, or
sleeves (recent accessory)
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
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
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
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
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.
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
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
0% (no one) reported any negative side
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
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
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.
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
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.