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A collection of reviews by medical professionals as to the effectiveness of the ReBuilder Device for nerve pain treatment

Mayo Clinic | April 2014


Renee S. Hartz MD, David B. Phillips Ph.D., Rita Wickham Ph.D., RN., John Hayes Jr DC, Jill Howe DC, Dynamic Health and Wellness Center, Crystal Lake, Il, USA


Renee S. Hartz, MD Dynamic Health and Wellness, Crystal Lake, Il
1032 Baldwin Lane
Oak Park, Il 60302
rshartzmd [at] aol.com
facsimile 708-386-5547

David B. Phillips, Ph.D. ReBuilder Medical, Inc.
davidphillipsmail [at] yahoo.com


Rita Wickham Ph.D. Northern Michigan University
rwickham [at] nmu.edu

John Hayes Jr, DC
johnhayesjr1 [at] gmail.com


Jill Howe, DC, Dynamic Health and Wellness Center, Crystal Lake, Il
jhowe [at] experiencewellnessnaturally.com

Abstract:

We treated 551 patients for their Nerve Pain (Peripheral Neuropathy) using ReBuilder. ReBuilder, a unique TENS/EMS electrical stimulation device - used to determine if it improved the quality of the patients' life. Fully 94% reported success. The patients reported no side effects. The ReBuilder is safe and effective for treating peripheral neuropathy.

Figures:

  • Treating patients feet using the split compartment electrode-containing solution.
  • Silver laced conductive gloves (not used in this trial). Socks also available.
  • Close up of the ReBuilder®. Note the small size and portable nature.
  • Mean pain ratings before and after using the ReBuilder®.

 

Introduction

Peripheral neuropathy (PN) is the most common neuromuscular disorder and usually presents as symmetric distal polyneuropathy. The estimated incidence of Peripheral Neuropathy in the general population is 2.4% and 8% in persons older than 55 (1). The most frequently reported cause of Peripheral Neuropathy is diabetes; 40%-50% of patients who have had type 2 diabetes for >10 years have Peripheral Neuropathy and 26% of all diabetic patients have painful Peripheral Neuropathy (2,3). Another risk group is cancer patients who receive chemotherapy agents that are neurotoxic to the peripheral nervous system. These agents include (platinum analogs, taxanes, vinca alkaloids, thalidomide, bortezomib, and ixabepilone) (4,5). PN also occurs in patients with HIV and may arise in those with amyloidosis, Sjogren’s syndrome, or other conditions. In many cases is idiopathic (6,7,8). Whatever the cause, PN often causes significant morbidity PN can alter mobility and balance, fatigue, depression, anxiety, and decreased quality of life (9).

Peripheral Neuropathy has an insidious onset. Starting in the distal ends of the longest neurons and progressing slowly over months to years. Manifestations originate in the toes and fingers. It then gradually progress to the feet and hands (stocking and glove pattern). It rarely extends to above the knees and the elbows (8). Although Peripheral Neuropathy can affect motor and (rarely) autonomic nerves, large and small afferent sensory neurons are most often affected by PN. Manifestations may include distressing bilateral nerve pain, paresthesia, and impaired temperature, touch, vibratory sense, proprioception, and loss of deep tendon reflexes (DTRs) (10). Some individuals also experience difficult to manage neuropathic pain in the affected areas. This arises as a direct consequence of the pathogenic event affecting the peripheral somatosensory system (11). In addition to paresthesias, individuals may experience other symptoms. These symptoms reflect damage to small A and C nerve fibers. Shooting, electric or shock-like, or stabbing (lancinating or knife-like) pain (9,12). Other persons report allodynia after contact with non-painful stimuli (e.g. clothing or bed sheets against the skin), pain when walking that feels like walking on marbles or on hot sand, or feelings of heat, burning, or cold in their feet.

Most research has focused on diabetic neuropathy. There are few adequately powered, well-designed studies to firmly establish optimal pharmacologic treatment (Bril, et al, 2011)(13). Research regarding the management of Peripheral Neuropathy from other causes lags behind.

There is little data supporting the use of non-pharmacologic measures. However, there is some intriguing data regarding transcutaneous nerve stimulation (TENS) and related technologies. For instance, Jin and colleagues (2010) (17) reviewed the literature to identify studies comparing TENS to sham treatment for symptomatic diabetic Peripheral Neuropathy. They identified only three small studies that met the inclusion criteria. These studies confirmed that active TENS (alone or with amitriptyline) used for 30 minutes once a day for 4-12 weeks was significantly superior to placebo in reducing pain and subjective symptoms of Peripheral Neuropathy. Similarly, Pieber and others (2010) (18) reviewed 15 studies of TENS and other forms of external electrotherapy. (e.g. pulsed dose electrical stimulation, high-frequency muscle stimulation, frequency-modulated electromagnetic neural stimulation). They concluded these methods are continued benefits for patients with painful diabetic PN. Although four of the studies reviewed suffered from small sample sizes, most lacked a placebo or control group. Follow up was inconsistent across studies. Interestingly, there was some evidence that the electrical stimulation methods might be more effective than TENS. Hypotheses for these therapies is that they may act by supraspinal mechanisms, modulate descending inhibitory pathways, increase pain threshold, influence calcitonin, reduce windup, or reduce nerve impulse transmission from damaged neurons.

Our clinical observations and reports from patients experiencing painful PN that support the potential value of a new device, ReBuilder®. (22) ReBuilder® is designed to deliver dual electrical stimulation to muscle and nerve tissues (ReBuilder Medical Inc.). We were encouraged to develop a more rigorous rationale for using or recommending this device. After discussions with several of our patients and their physicians. These patients and physicians expressed extreme frustration at the lack of effective therapeutic options. Some patients even expressed suicidal thoughts because of unrelieved Peripheral Neuropathy and pain. These findings form the basis for this preliminary study. A review and analysis of patient-generated data collected by ReBuilder Medical Inc.

Methods

The ReBuilder® device is registered with and approved by the FDA as a 510K pre-amendment version TENS (transcutaneous electrical stimulator) and an electronic muscle stimulator (EMS )(24). The ReBuilder® delivers energy via cutaneous electrodes to each foot (and hand, if indicated). It is placed in one compartment of an electrically isolated split compartment bath containing an electrolyte mixture(figure 2) (newer versions offer the alternative of silver-impregnated socks and gloves) (figure 1). According to the manufacturer, the ReBuilder® individualizes its outputs based on the physical mass and digital impedance of the individual using it (http://rebuildermedical.com) which gives an unequaled level of safety.

The very real medical advance is in the use of an internal microprocessor that analyzes the patient’s current, dysfunctional peripheral nerve waveform, and then designs a compensating waveform (like noise-canceling headphones) that it delivers to all the peripheral nerves from the spinal cord to the feet. Just as a pacemaker must imitate the waveform of a healthy heart or risk retrograde blood flow, it is reasonable that the peripheral nerves function via a very specific waveform. A common TENS device delivers a constant square wave that is foreign to the nerves.

ReBuilder's® Impulses utilize very small amounts of current under the curve and a relatively high transient voltage of 40-90 volts. The resultant current is below that commonly produced by traditional TENS units. The device delivers a second, simultaneous, lower voltage (5-20 volts), wider waveform signal designed to stimulate muscle tissue. This signal causes the muscles of the feet, calves, and thighs and buttocks to intermittently contract and relax. Stimulating the venous muscle pump to empty veins thus allowing whatever arterial pressure is present to rapidly fill the vacated veins. This enhances local blood flow. Using this dual stimulation (80% nerve stimulation and 20% muscle stimulation) is pulsed at a frequency of 7.83 cycles per second. Theoretically, this allows afferent neurons time to repolarize between pulses. The dual stimulation is hypothesized to travel from the distal end of the ascending sensory neuron, across the spinal interneuron, and down to the distal end of the motor neuron in the contralateral limb (monograph).

Sample

551 individuals who purchased the ReBuilder between December 2002 and May 2004 comprised this convenience sample. These individuals responded to an Internet advertisement offering a financial incentive for trying a new treatment for peripheral neuropathy. The package the 551 respondents received included a ReBuilder device and a simple survey questionnaire which they filled out and returned within three months. They were also asked to record their reason for using the device (pain or other symptoms) and to rate their pain, if applicable, on a numerical rating scale (NRS) of 1 (least) to 10 (worst) before and after using the device.

Statistical Analysis

Statistical tests were performed using the SPSS software version 20 (IBM, Armonk, N.Y.), and included calculation of descriptive statistics, means, and frequencies for putting together categorical variables. Using a paired t-test to examine any differences in beginning and end of trial pain ratings in persons who reported initially reported pain. We performed a one-way analysis of variance (ANOVA), comparing the differences in pain score changes in the 3 groups of respondents; a) those reporting an improvement in pain, b) those who were unsure whether their pain improved, and c) those who stated that their pain had not improved.

Results

Excluded were twenty records, due to conflicting or confusing data. The remaining 531 records formed the basis of this report. Eighty-eight percent of respondents did not know the cause of their PN. Only 7% reported their neuropathy was due to diabetes, 3% reported it was anatomic, and 1% each reported toxic or vascular causes. We asked for no other demographic data. ANOVA revealed a significantly greater reduction in pain score in 'yes' responders, as compared to the 'equivocal' and 'no' responders (p<0.0001). In addition, 94% of respondents reported improved quality of life after using the ReBuilder. A greater number of individuals reported on their satisfaction with pain relief (n = 515) than initially reported pain (n = 456). This discrepancy is explained by individuals who initially reported severe nerve pain or tingling in their feet but still reported an improvement in pain score.

Testimonials from the questionnaires were not analyzed statistically.
The most common comments were "miraculous relief," "I can feel my feet again, " I am no longer suicidal," and "I have a life again."
Unexpected comments included ulcer-healing in 3 patients, resolution of fungal nail infection in one, and improved sexual function in 3 patients.

Discussion

One potential advantage of the ReBuilder over other technologies including ST5 or TENS is its simplicity of use. In particular, the ST5 treatment must be administered in the clinic and ideally administered by a specially trained clinician. The manufacturer of the ST5 now requires that physicians attend a three-day training course. Additionally, the correct placement of electrodes for optimal local pain relief is why this course is required(23). There are two versions of the ReBuilder, both FDA registered. One device for home use and one device for clinic setting use.

There are numerous causes of peripheral neuropathies. Axonal degeneration, occurring secondary to accumulation of toxins or neurotoxic agents could be the cause. Also, vitamin deficiencies inherited genetic abnormalities, hyperglycemia and glucose accumulation within neurons, or other causes(25). The external environment of neurons, such as vascular compromise or ischemia, inflammation, and oxidative stress may cause secondary demyelination and axonal dysfunction(2). Involvement of small and large sensory neurons often leads to manifestations such as nerve pain, tingling, dysesthesia and burning, as well as a change in temperature sensation and proprioception, and loss of DTRs. Resulting neuropathies may lead to severe pain, disability, erectile dysfunction, impaired ability to walk and drive safely, and decreased quality of life(23).

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 improvement(26,27). The treatment has been directed largely at relieving symptoms rather than treating the underlying cause. A common TENS is a simple, non-invasive treatment for neuropathic pain based on the gate control theory(28). that proposes stimulation of large myelinated A-fibers inhibits transmission of painful afferent impulses from A ? and C fibers to the dorsal horn of the spinal cord, thereby closing the gate. This hypothesis may be too simplistic, as central mechanisms may be involved. Furthermore, TENS therapy may not change C or A? mediated thresholds or perceptions (e.g. cold, warmth, cold or heat pain, vibration or touch)(29). TENS may be useful for localized neuropathic pain related to diabetes and other conditions and often leads to improvement of pain that diminishes with the cessation of TENS use(17,18,29) was an overall improvement in Peripheral Neuropathy pain at twelve weeks of treatment. Current evidence-based guidelines conclude TENS is "probably effective in lessening the pain of painful diabetic neuropathy and improving quality of life" (Bril et al)(13). The primary method of action is that of blocking the nerve path by overstimulating the nerve cell with a foreign waveform simple squarewave) delivered at a higher rate than 7.83 Hz (the rate required for a nerve cell to repolarize).

The ReBuilder is distinctly different from traditional TENS units. From "scrambling" types of electrical stimulation, its design opens the nerve paths rather than closing them. It also improves the microcirculation, re-polarizes and re-educates the nerves to follow the correct pathways rather than to confuse the nerve fibers. Its simple design allows for home use. Recent versions include silver-impregnated gloves and stockings for home use, to avoid the electrolyte bath, further simplifying the treatment process and making it portable.

Limitations

There is little information about the self-selected sample, particularly in terms of etiology and duration of Peripheral Neuropathy, and other medical data. Additionally, there is no follow up data regarding continued use and duration of pain relief in the yes responders. Correspondingly, we cannot say whether those whose responses were 'equivocal' or 'no' would respond with further use of the ReBuilder; that is we do not know the time frame in which the onset of and maximal pain relief occur.

Conclusion

We have found no other published data or information that includes a large number of individuals (more than 500) experiencing painful neuropathy detailed in our report. Despite the limitations identified, we believe this provides compelling information that should drive larger prospective studies. Future studies should answer further questions that remain open: 1) can use of the ReBuilder return some degree of peripheral normal sensation 2) is pain reduction lasting or not 3) can the ReBuilder delay the onset of Peripheral Neuropathy in patients with diabetes or those who are prescribed neurotoxic chemotherapy? Other investigators may also be interested in elucidating the mechanisms of pain relief of the ReBuilder. Our hypothesis is that: The electric stimuli promote healing of the microcirculation and re-direct the small neurons into an appropriate arrangement. Finally, nerve conduction velocity (NCV) studies are considered the gold standard of diagnosing Peripheral Neuropathy, and should be included in future studies pre- and post-treatment to determine whether velocity improves. In this unpublished study, The ReBuilder is found to be safe and effective in mitigating pain in peripheral neuropathy. Therefore we highly recommend the ReBuilder as a first choice for you to consider in the management of pain as a symptom of peripheral neuropathy.

Figure 1
The ReBuilder 2407 in Carpal Tunnel Syndrome Care

Figure 2
Patient Treating Diabetic PN Feet with ReBuilder 2407 in an electrically isolated split compartment bath containing an electrolyte mixture.


References

  1. England JD & Asbury AK. Peripheral neuropathy.2004; Lancet 363: 2151-2161.
  2. Little AA, Edwards JL, Feldman EL. Diabetic Neuropathies. 2007; Pract Neurol 7: 82-92.
  3. Boulton AJM. Management of diabetic peripheral neuropathy.2005; Clin Diabetes 23: 9-15.
  4. Malik B & Stillman M. Chemotherapy-induced peripheral neuropathy.2008; Curr Neurol Neurosci Rep8: 56-65.
  5. Wickham R. Chemotherapy-induced peripheral neuropathy: a review and implications for oncology nursing practice. 2007; Clinl J Oncol Nurs 11:361-376.
  6. Chaia J & Logigian EL. Neurological manifestations of primary Sjogren's syndrome. Curr Opin Neurol. 2010; 23:509-513.
  7. Simpson DM, Schifitto G, Clifford DB, et al. Pregabalin for painful HIV neuropathy. A randomized, double-blind, placebo-controlled trial.2010; Neurology; 74:413-420.
  8. Vavra MW & Rubin DI. The peripheral neuropathy evaluation in an office-based neurology setting. 2011; Semin Neurol 31:102-114.
  9. Tesfaye S. Advances in the management of diabetic peripheral neuropathy.2009; Curr Opin Support Palliat Care 3:136-143.
  10. Kanji JN, Anglin RES, Hunt DL, Panju A. Does this patient with large-fiber peripheral neuropathy?2010; JAMA303:1526-1532.
  11. Treede R-D, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, et al. Neuropathic pain. Redefinition and a grading system for clinical and research purposes.2008; Neurol 70: 1630-1635.
  12. Hovaguimian A & Gibbons CH. Diagnosis and treatment of pain in small-fiber neuropathy. 2011; Curr Pain Headache Rep 15:193-200.
  13. Bril V, England J, Franklin M, et al, Evidence-based guideline: Treatment of painful diabetic neuropathy. 2011;Neurology 76:1758-1765.
  14. Jensen TS, Madsen CS, & Finnerup NB. Pharmacology and treatment of neuropathic pains. 2009; Curr Opin Neurol 22:467-474.
  15. Rahn EJ & Hohmann AG. Cannabinoids as pharmacotherapies for neuropathic pain: from the bench to the bedside. 2009; Neurotherapeutics 6: 713-737.
  16. Wilsey B, Marcotte T, Tsodikov A, Millman J, et al. A randomized placebo-controlled crossover trial of cannabis cigarettes in neuropathic pain.2008; Pain 9:506-521.
  17. Jin D-m, Xu Y, Geng D-F, Tan T-B. Effect of transcutaneous electrical nerve stimulation in symptomatic diabetic peripheral neuropathy: A meta-analysis of randomized controlled trials. 2010; Diabetes Res Clin Pract 89:10-15.
  18. Pieber K, Herceg M, Pernostro-Sluga T. Electrotherapy for the treatment of painful diabetic peripheral neuropathy: a review. 2010; J Rehab Med 42: 289-95.
  19. Ricci M, Pirotti S, Scarpi E, Burgio M, et al. Managing chronic pain: Results from an open-label study using MC5-A Calmare device. 2011; Support Care CancerMar 11, Epub PMID21394458
  20. Sabato AF, Marineo G, & Gatti A. Scrambler Therapy. 2005; Minerva Anesthesiol 71: 479-482.
  21. Smith TJ, Coyne PJ, Parker GL, Dodson P et al. Pilot trial of a patient-specific cutaneous electrostimulation device (MC5-A Calmare ) for chemotherapy-induced peripheral neuropathy. 2010; J Pain Symptom Manage 40:883-891.
  22. Phillips DB. The ReBuilder System effective Treatment for Neuropathy and Chronic Pain. 2007;(http://www.rebuildermedical.com/monograph.php
  23. Gormsen L, Rosenberg R, Bach FW, & Jensen TS. Depression, anxiety, health-related quality of life and pain in patients with chronic fibromyalgia and neuropathic pain. 2010; Eur J Pain 14: e1-e8.
  24. Marineo G. Inaccuracy in the article "Managing chronic pain: results from an open-label study using MC5-A Calmare device in Support Care Cancer" (letter). 2011. Support Care Cancer 19:1483-1484.
  25. Head A. Peripheral neuropathy: Pathogenic mechanisms and alternative therapies.2006; Alter Med Rev 11:294-329, 2006
  26. Aring AM, Jones DE, & Falco JM. Evaluation and prevention of diabetic neuropathy. Am Fam Physician 71:2123-2128, 2005.
  27. Ismail-Beigi F, Craven T, Banerji MA, Basile J, Calles jet al. Effect of intensive treatment of hyperglycemia on microvascular outcomes in type 2 diabetes: an analysis of the ACCORD randomized trial. 2010; Lancet 376, 419-430.
  28. Chong MS & Bajwa ZH. Diagnosis and treatment of neuropathic pain. 2003; J Pain Symptom Manage 25 (suppl 5S): S4-S11.
  29. Dubinsky RM & Miyasaki J. Assessment: Efficacy of transcutaneous electric nerve stimulation in the treatment of pain in neurologic disorders (an evidence-based review). 2010;Neurol 74:173-176.

James R. Arnold D.P.M.

There are approximately 16 Million diabetics in the United States, and the World Health Organization estimates that there will be 220 million people worldwide with diabetes by 2010. According to reports, early 50% of the people with diabetes have diabetic polyneuropathy. (1) The neuropathy is associated with the pain in approximately 10% of those patients. Although studies show a relationship between hyperglycemia and the development and severity of diabetic neuropathy, even more, researchers are still unraveling the exact pathophysiology of painful diabetic neuropathy. Currently, both pharmacological and nonpharmacological treatment options are available, but unfortunately, to date, there is no fully effective treatment. (2) I tested the effectiveness of The Rebuilder System, an electronic neuromuscular stimulator, in a small, open-labeled study of 6 patients with painful diabetic neuropathy. I assessed the ease of use, tolerability and the relief of their neuropathic pain symptoms.

Methods

I selected six of my patients who complained about their uncontrolled diabetic neuropathy pain. Consequently, all patients agreed to keep track of their results. Concurrent use of pharmacological therapy was not an exclusion factor. Within 30 days of starting the neuromuscular stimulator, patients had no new treatment regimes. Then I created evenly distributed Insulin and non-insulin dependent diabetics groups. There length of time with diagnosed diabetes ranged from one year to twenty-two years; however, the painful diabetic neuropathy ranged from 6 months to 8 years. Two patients were currently taking Neurontin and one was on Elavil. Previous treatments varied from Acupuncture, electrical stimulation, nerve blocks and topical creams to pharmacological agents. I stopped Data recording at 8 weeks.

Pain levels using a 0-10 pain scale, with 0 meaning the patient had no pain and 10 being the highest rating of intolerable pain.

Furthermore, we provided a 15-minute instructional session on using the simulator and a videotape to the patients.

Results

First of all, all six patients found the device easy to use and stated the original 15-minute demonstration and video was enough instruction for them. All patients finished the eight-week study and were planning on continuing use of the neuromuscular stimulator. When setting ReBuilder at a tolerable setting, patients reported Muscular contraction in the feet and legs.

All 6 patients had a reduction in pain. Original pain levels ranged from 5 to 10. The average reduction on the pain scale was three levels after a two-weeks and five levels by the end of the study. Four of the patients had trouble falling to sleep before the study and all noted improvement within two days of starting the neuromuscular stimulator.

Patients reported no adverse reactions or allergies.

Discussion

There are however many advantages of using the electronic neuromuscular stimulator over pharmacological agents for the treatment of painful diabetic neuropathy. Pharmacological therapy includes tricyclic antidepressants, narcotic analgesics, anticonvulsants, and antiarrhythmics. Tricyclic antidepressants have been long considered the standard for chronic diabetic nerve pain, and provide significant pain relief to 30% of patients who have neuropathic pain. Unfortunately, most patients experience intolerable adverse effects such as sedation, dry mouth, urinary retention, orthostatic hypotension or cardiac arrhythmias. Narcotic analgesics are, in a word considered controversial for the treatment of neuropathic pain. The high doses need to relieve the neuropathic pain often lead to constipation and addiction. The anticonvulsant, gabapentin, has become a popular treatment; however, it's high price often makes it cost prohibitive and its side effects are considerable. Dizziness 24%, somnolence 23%, headache, and diarrhea 11% - reported by patients. Care: Taken with the antiarrhythmics, and serum level monitored. (3)

The electronic neuromuscular stimulator provides an easy to use, low side effect option that has been shown to provide significant pain relief in patients that suffer from painful diabetic neuropathy. The relief of neuropathic pain may allow some patients to sleep better and increase their quality of life. Use of the electronic neuromuscular stimulator does not prohibit concomitant use of a pharmacological agent.

In conclusion, the electronic neuromuscular stimulator was easy to use and shows promise as a well tolerated, effective treatment for painful diabetic neuropathy. A double-blind, randomized trial must be conducted to confirm my observations.

Abstract

Sixty patients, with chronic pain of diverse etiologies, were treated with a modified TENS technique using a relatively inexpensive, low-frequency electro stimulator. The method and results of treatment are described, and possible explanations for the effectiveness of TENS therapy are examined. In summary, clinical experience indicates a relief rate of 88% in those cases studied, with observed pain relief varying both in duration and degree. Analgesic and anti-inflammatory effects were also noted. The ongoing home use of TENS patients is encouraged.</p>

January 1986

Robert D. Milne, M.D. and Fuller Royal, M.D.
The Nevada Clinic
6105 West Tropicana Avenue
Las Vegas, Nevada 89103
(702) 871-2700

Introduction

Clinical interest is heightening in the use of transcutaneous electrical nerve stimulation (TENS) for control of pain syndromes of diverse etiologies (13, 4, 12). Recent studies have demonstrated the efficacy of TENS for the treatment of acute postoperative incision pain, and it has become an accepted alternative to conventional methods of treatment (6). Rheumatoid arthritis pain has been successfully treated with TENS (1).

This study, which is part of a continuing attempt to assess the practical uses of TENS, was designed to test the hypothesis that specific low-frequency electrostimulation provides effective reduction of relatively non-severe pain and that it can be a useful adjunct for the overall approach to pain control.

Methods

Sixty patients with chronic pain consented for treatment. Each patient reported continuous or intermittent pain and had been previously seen by orthopedic and/or neurology physicians. Within this group of 60, 44 patients were considered to be suffering from mild to moderate pain; 6 other patients were classified as severe.

Previous studies have indicated the effectiveness of wrist and ankle stimulation for treatment of pain syndrome (7). Low-frequency stimulation has also been used with good success (8).

We felt that many of our patients had difficulty in understanding the proper application of TENS electrodes and we sought to find a simple, more universal approach for this study. The method ultimately selected for use is known under the appellation "REBUILDER® Footbath System."1 Using this method, the patient receives low-frequency electrostimulation (within a range of 7-to-8 Hz.) from a portable, single-channel, battery-operated device (REBUILDER) while appropriate portions of the body are immersed in water.

Patients were first directed to fill ankle-deep with warm water a special twin-compartment plastic bucket. The patient then placed one foot or hand, along with one electrode lead connected to the electro-stimulator device, into the water on each side of the bucket.

The device's power dial was then turned on until a "tingling" sensation was felt in the submerged portions of the body. Once the "tingling" was felt, low-frequency electrostimulation was continued for a period of ten minutes for both the feet and hands. Treatments were self-administered once daily for periods of two weeks or longer. If no response was noted after two weeks, the treatment was termed a failure.

Results

Data accumulated from 60 patients using the REBUILDER Footbath System are summarized below in Table I.

Table I. Statistical Summary of “REBUILDER Footbath System” Study Results

Diagnosis Number of Cases No Relief Initial Relief Long-Term Relief
Osteoarthritis 18 1 2 15
Low Back Pain 13 2 3 8
Neck Pain 7 1 2 4
Elbow Pain 3 0 2 1
Foot Pain 4 0 1 3
Post-Herpetic Neuralgia 2 0 1 1
Headaches 13 3 4 6
TOTAL 60 7 15 38

PERCENTAGE RELIEF: 88%
PERCENTAGE LONG-TERM RELIEF: 63%
PERCENTAGE NO RELIEF (after 5-to-6 treatments): 12%

Since pain is a subjective phenomenon, the reduction of which it is difficult to a subjective scale. Responses were verbally elicited, along a scale ranging from 0-to-10, whereby a rating of 10 equated to "most severe pain" while a rating of 0/1 equated to "least pain. (11)

Responses were then grouped and classified into one of three categories: "no relief"; significant relief (i.e., greater than 50% less pain), but lasting only through the "initial" treatments; and "long-term" or continued relief lasting throughout an additional three-to-six months of use.

As documented in Table 1, the most gratifying results were obtained in elderly patients with osteoarthritis, whereby 15 out of 18 patients reported long-term relief. This finding is similar to that reported in a previously published study. Only one patient of the 18 we tested in this category was unaffected by treatment, and she had a severe deformity. Most other patients in this category noted decreased joint swelling in addition to continued pain relief.

Six out of the 13 patients tested with migraine/headache syndrome achieved long-term relief using low-frequency, electrostimulation therapy. However, TENS therapy proved most helpful for the prodromal stage; for acute-phase sufferers, it was minimally effective and more invasive acupuncture/medication techniques were necessary.

An interesting use was noted by Dr. Corson of a man with severe debilitating knee pain who had been recommended for knee-replacement surgery. He had such complete relief that he went out and worked in the yard all day and called in saying the knees were okay but he now had the cramps in his calves. His medication and vitamins were adjusted and he had improved.

Discussion

The long-term pain reduction noted in 63% of the patients with mild to moderate pain suggests that TENS stimulation, employing low- frequency electrical current, is effective in relieving moderate pain. Further, the anti-inflammatory effects of such electrostimulation techniques are encouraging. This has been noted by other investigators (8), while prior studies have also documented the significant healing of osteoarthritic joints, as demonstrated by x-ray examination. By way of explanation, Becker and his co-workers have suggested that this noted augmentation of normal healing results from amplification of a neural control signal that is more primitive than the discrete action potential. (2, 3) In particular, Becker et al feel that the perineural cells compose a DC control system and that the Schwann cells transmit the current of injury, which is interpreted consciously as pain.

Other theories of action include the various "gate" theories summarized briefly below:

  1. Supranuclear or Psychic Gate Theory -- argues that pain is blocked at the supranuclear/psychic level by suggestion, hypnosis, or placebo;
  2. Thalamic Gate Theory -- argues that vibratory sensations activate the large A-beta fibers which, on reaching the thalamus, cause the reticular formation and limbic system to shut the "gate" on pain ascending through the spinothalamic and bulfothalamic tracts;
  3. Spinal Gate Theory (by Melzack and Wall (10)) -- argues that large, more rapidly conducting A-beta fibers transmit the vibratory sensation of TENS, which enters the dorsal horn of the spinal chord and activates cells of the substantia gelatinosa, in turn, causing blockage of pain sensations arriving via the slower-conducting unmyelinated C-fibers at the segmental level; and
  4. Peripheral Gate Theory {by Campbell and Taub (5)) -- argues that the pain and touch threshold is increased in the distal portion of extremities by percutaneous electrical nerve stimulation as a result of the blockage of peripheral sensory fibers.

However, none ·of these “gate” theories is ab 1e to explain the fact that in most instances TENS affords pain relief of prolonged duration. We suggest that there is evidence that alteration of the cellular metabolism at the site of origin of focal pain can result in significant relief of varying duration and degree. We further propose that as Western physicians become increasingly adept at comprehending the true nature of the Yin and Yang balance of Chinese medical theory, and as further investigations of quantum physics dynamics on the subcellular energetic systems yield new information, it will become possible to formulate a more definitive theory of explanation.

The use of a simple, effective, inexpensive, and portable TENS device achieves clinical significance in light of the burgeoning cost of medical care. The use of such low-frequency electrostimulation techniques enables patients to obtain ongoing home treatment, at a reasonable cost, in between visits to their physicians.

Further studies are currently in progress to help better delineate the long-term effects of these devices.

References

  1. Abelson, K., et al. "Transcutaneous Electrical Nerve Stimulation in Rheumatoid Arthritis."· New Zealand Medical Journal March 9, 1983; 96:156-158.
  2. Becker, R.O. "The Significance of Bioelectric Potentials." Bioelectrochemistry and Bioenergetics [???] 1974; 1:187-199.
  3. Becker, R.O.; Reichmanis, M.; A.A.; and Spadero, J.A. "A Possible Biological Basis for Acupuncture." Psychoenergetic Systems [JOURNAL TITLE??? STILL IN PRESS -- (1978) ???].
  4. Burton, c.v. "Pain Suppression through Peripheral Nerve Stimulation." In Neural Organization and Its Relevance to Prosthetics. Monograph of Houston Neurological Symposium, 1972. [Place of Publication???]: Intercontinental Book Corporation, 1973, pp. 241-251.
  5. Campbell, J.N. and Taub, A. "Local Analgesia from Percutaneo.us Electrical Stimulation: A Peripheral Mechanism." Archives of Neurology[???] May 1973; 28:347-350.
  6. Cotter, Dennis J. "Overview of Transcutaneous Electrical Nerve Stimulation for Treatment of Acute Postoperative Pain." Medical Instrumentation July - Aug us_t 1983; 17.4:289-291.
  7. Hwang, Paul. "Wrist-Ankle Acupuncture: A New Technique." American Journal of Acupuncture April-June 1977; 5.2:129.
  8. Ledergerber, Charles P. "Transcutaneous Electroacupuncture and Electroanalgesia." American Journal.£! Acupuncture April-June 1979; 7.2:127.
  9. Man, P.L. and Chen, C.H. "Mechanism of Acupunctural Anesthesia." Diseases of the Nervous System November 1972; 33:730-735.
  10. Melzack, R. and Wall, P.D. "Pain Mechanism: A New Theory." Science November 19, 1965; 150:971-979.
  11. Rice, M.C. Electricity .!.!!. GynecolOl{Y• Laing Co., 1909. Chicago, Illinois: L. I.
  12. Shealy, C.N. "Six Years Experience with Electrical Stimulation for Control of Pain." Advances in Neurology 1974; 4:775-783.
  13. Sweet, W.H. and Wepsic, J.G. "Electrical Stimulation for Suppression of Pain in Man." In Neural Organization and Its Relevance to Prosthetics. Monograph of Houston Neurological Symposium,1972. [Place of Publication???]: Intercontinental Book Corporation, 1973, pp. 219-240.
  14. Wall, P.D. and Gutnik, M. "Properties of Afferent Nerve Impulses Originating from a Neuroma." Nature April 1974; 248:740-743.

1The REBUILDER® Footbath System is a trademark of Micromed, Inc. (Address: 13150 Windbreak Road, San Diego, California 92130; Telephone No.: 619-259-0701), which also developed and manufactures the system.

JOHN C. KELLY, M.D.
975 Ryland Street
Reno, Nevada 89502

July 15, 1988

Micromed, Incorporated
15 Brickyard Road
Essex Junction, Vermont 05452

ATTENTION: Mr. David Phillips

Dear Mr. Phillips:

Pursuant to your request as to the implementation and utilization of ReBuilder, in Las Vegas last year, you introduced to your product after your demonstration. The ability of the product to provide significant endorphin production vis-a-vis the TENS unit impressed me significantly. I have additionally used the product on three patients for pain control of peripherovascular origin. These patients have significant claudication, vis-a-vis chronic, debilitating and uncontrolled diabetes mellitis, and significant arteriosclerotic heart disease. The very satisfactory endorphin effect as provided by the TENS unit has cut down any need for artificial analgesia. It also has given the patients a significant sensation and feeling of well-being, and their general compliance and attitude toward their disease have improved.

As another observation, upon prescribing it for pain · medication, we also observed some significant changes in the EMS application that we experimented with because it was available on the unit. Additionally, these individuals have received increased vascular flow in the lower extremities and in two cases, the patients have had substantial improvement and acceleration of healing of venous stasis ulcers, vis-a-vis the use of the EMS on a twice a day basis. Additionally, I have done some Doppler evaluations and have noticed a significant improvement in collateral circulation in two of the three patients. Furthermore, it is my feeling that this is a significant area of opportunity in an application that you should explore. The cases we observe specifically- increased perfusion and decreased emptying time in both lower extremities, and as previously stated, an accelerated improvement in venous stasis ulcer.

"a significant breakthrough in the area not only of diabetic neuropathy"

As you know, EMS has been used for motion of musculoskeletal toning and in particular situations such as these, where we have a great deal of lymphedema and decreased vascular flow, it is obvious that there is a significant change in the perfusion of the lower extremity, and a study performed to evaluate in depth this modality and application, for I think it may be a significant breakthrough in the area not only of diabetic neuropathy from the pain stand-point but from the perfusion standpoint.

"patients have had substantial improvement and acceleration of healing"

Furthermore, I recommend conducting studies in the area of peripheral revascularization, especially in the cardiac bypass patient. We have one candidate who has received 5 vessel bypass this last week and with whom we have discussed the possibility of using ReBuilder to increase circulation. He is amenable to same at this time, not only in pain control due to the extent and significance of the incision, but from the EMS standpoint to encourage deep vein collateral circulation, in that removal of the saphenous to support re-vascularization in the bypass.

Consequently, the professionalism that Micromed has undertaken at this time impresses me. Additionally, there has been no overstating of claims. I think one must, however, as one addresses the Micromed product, realize that willy-nilly use of this prescription item shouldn't be the basis. Furthermore, it requires an evaluation by a competent physician. Furthermore, the physicians understanding his patient and understanding the bio-physiology of the EMS and TENS capability that the unit has, and then applying this in a fashion to the best interest and most effective treatment modality for his patient's interest.

Therefore, I look forward to observing an expanding role for your equipment in the establishment of endorphins as an adjunct to removing people from the substance abuse arena by using such entities as external and exogenous sources of medication and look forward also to the arena of an expanding cardiovascular role for your equipment.

Sincerely yours for better health,

John C. Kelly, M.D.

ReBuilder® Monograph – PDF Download

The ReBuilder® Treatment System is designed to be simple to use in the home or in the physician’s office, is non-invasive, safe, effective, affordable, is registered with the FDA and cleared by 510K K882980, and is covered by many insurance plans. The ReBuilder unit has simple to use controls, uses electrode pads that are placed directly on the bottoms of both feet or on the affected body part. It has no interaction with, nor does it interfere with, any medications the patient may be taking. Having a much more powerful electrical impulse than that of the human body, the ReBuilder re-polarizes and re-educates the nerves to follow the correct paths. It also enables nerve impulses to jump the synaptic junction, reconnect the injured nerve cells, and deliver minerals and nutrients which revitalize those nerves. When this is accomplished, it promotes new nerve growth, restores blood circulation, returns feeling to the patient’s extremities, and reduces pain. In many cases, the ReBuilder actually reverses chronic pain symptoms and restores nerves to their normal state allowing them to fully function on their own thereby reducing the need for medications.

Download the PDF for:

“A Monograph”
by Dr. David B. Phillips – Inventor of ReBuilder®

( You will see the download pop up at the bottom of your screen where you can choose what to do with it. )

Monograph PDF Download

Journal of the American Podiatric Medical Association • Vol 92 • No 3 • March 2002

Alan B. Kochman, MSPT | Dale H. Carnegie, DPM | Thomas J. Burke, PhD


 

Forty-nine consecutive subjects with established diabetic peripheral neuropathy were treated with monochromatic near-infrared photo energy(MIRE) to determine if there was an improvement of sensation. Loss of protective sensation characterized by Semmes-Weinstein monofilament values of 4.56 and above was present in 100% of subjects (range, 4.56 to 6.45), and 42 subjects (86%) had Semmes-Weinstein values of 5.07 or higher. The ability to discriminate between hot and cold sensation was absent (54%) or impaired (46%) in both groups prior to the initiation of MIRE treatment. On the basis of Semmes-Weinstein monofilament values, 48 subjects (98%) exhibited improved sensation after 6 treatments, and all subjects had improved sensation after 12 treatments. Therefore, MIRE may be a safe, drug-free, noninvasive treatment for the consistent and predictable improvement of sensation in diabetic patients with peripheral neuropathy of the feet. (J Am Podiatr Med Assoc 92(3): 125-130, 2002)

October 25, 2010

Dr. David Phillips
CEO and Founder
ReBuilder Medical

RE: ReBuilder® System

On behalf of the Oncology Rehabilitation team and the Medical Staff at Midwestern Regional Medical Center, I want to personally thank you for inventing and developing the ReBuilder System, a fabulous medical device to help alleviate the symptoms of Peripheral Neuropathy. In the past, we have used traditional physical therapy electrical stimulation devices such as traditional TENS and Interferential Current (IFC), but the ReBuilder System provided our patients with Chemotherapy Induced Peripheral Neuropathy (CIPN) the best and longest lasting pain relief while undergoing chemotherapy treatment.

From 2005 to 2007 we treated 124 cancer patients with CIPN who were actively undergoing chemotherapy treatment at Midwestern Regional Medical Center of which 40% reported a 30% to 50% reduction in their pain scale, 53% reporting 10% to 20% reduction in their pain scale, and 3% reporting 50% or more reduction in their pain scale, and only 4% reported no change.

With these remarkable results (96% success rate) the ReBuilder System is now being used across all four CTCA sites in Tulsa, Phoenix, Philadelphia, and Chicago – touching and helping more oncology patients relieve their CIPN symptoms. This calendar year alone, between all four sites, we have treated over 300 patients successfully.

We believe in your product’s ability to alleviate CIPN symptoms for cancer patients receiving chemotherapy. Patients have reduced or stopped taking pain medicine such as Gabapentin and Lyrica for CIPN.

At CTCA…

“It is only… and always will be…..about the patient.” Richard Stephenson, Chairman of the Board at Cancer Treatment Centers of America

Subjective Patient's Response

Neuropathy & Clinical Research

Chemotherapy is often used to treat different types of cancer. Unfortunately, the use of chemicals to breakdown certain parts of the body to kill cells will ultimately affect all fast dividing cells in the body. As a result several side-effects can and often do occur:

  • Pain
  • Nausea and vomiting
  • Diarrhea or constipation
  • Anemia
  • Malnutrition
  • Hair loss
  • Memory loss
  • Depression of the immune system, hence (potentially lethal) infections and sepsis
  • Weight loss or gain
  • Hemorrhage
  • Secondary neoplasms
  • Cardiotoxicity
  • Hepatotoxicity
  • Nephrotoxicity
  • Ototoxicity

There are currently about 15 widely used treatments for Neuropathy. However, more than half of these are treatments that involve some form of medicine to be relied upon. Thus, this results in more side-effects, the very things that caused the problem in the first place.

In some cases, hospitals are at risks when symptoms like Neuropathy occur. In cases where there is a misuse, misdiagnosis, or an overdose, the hospital may find themselves in the middle of a lawsuit by the person who received the treatment. The patient has the right to seek council if a misuse of treatment has cause Neuropathy or other related lasting effects.

Most of the common reported symptoms are:

  • Numbness
  • Tingling
  • Pain
  • Hypersensitivity
  • Stiffness

On average most patients are seen 1-2 x prior to going home with a home unit.

They continue to self treat at home. Instructions are given to use it daily up to 3x/day.

No actual data at this time for follow up. This will be the next step.

Maria Bloodworth, PharmD candidate

Marlon Honeywell, PharmD
Associate Professor of Pharmacy Practice

Charlie Colquitt, PharmD
Assistant Professor of Pharmacy Practice

Michael Thompson, PharmD, BCNSP
Professor of Pharmacy Practice, Assistant Dean of Clinical Affairs
Florida A&M University
College of Pharmacy
Tallahassee, Florida

Frank Emanuel, Pharm D
Division Director and Assistant
Professor, Florida A&M University
College of Pharmacy
Jacksonville, Florida

US Pharm. 2007;32(12):66-67.

It is estimated that 10 to 20 million Americans suffer from neuropathy. Associated with various etiologies including diabetes, neurotoxic chemotherapy, alcoholism, and nutrient deficiencies, neuropathy is a microvascular syndrome that affects the autonomic, sensory, and motor neurons of the peripheral nervous system. Neuropathy can be misdiagnosed or under-treated and eventually results in neuropathic pain. Neuropathic pain, which results from nerve cell dysfunction, is characterized by diminished sensation, numbness or tingling in the extremities, deep-seated pain, or increased sensitivity to pain. This malfunction can lead to upregulation of sodium and calcium channels, spinal hyperexcitability, descending facilitation, and aberrant sympathetic-somatic nervous-system interactions.

Neuropathic pain can be debilitating, crippling, and even fatal for some patients. Treatments for neuropathic pain commonly include nonpharmacological therapies, medications, and invasive procedures such as spinal-cord stimulation.2 Conventional pain medications may mask the symptoms associated with neuropathy; however, they are sometimes associated with significant side effects and addiction profiles. Many patients have moderate to severe pain and may require chronic use of multiple medications, which may lead to undesirable adverse reactions and, ultimately, poor patient compliance. Pain is one of the primary reasons patients seek medical attention. If it is improperly controlled, quality of life can be affected, resulting in decreased productivity at work, sleep deprivation, or anxiety or depression.

The ReBuilder

The ReBuilder is a noninvasive hand-held device approved by the FDA for the treatment of pain. This treatment device was designed based on the premise that oxygen deficiency is responsible for physical atrophy of nerve cells, which leads to the enlargement of the synaptic junction between the axon of one cell and the dendrites of the next. As a result, it is more difficult for normal-intensity electrical impulses to jump across this synaptic gap, ultimately causing neuropathy. The ReBuilder is designed to circumvent this gap by waking up dormant nerve cells, relaxing shrinking nerve cells, and restoring normal plus/minus polarity along the nerve axons and dendrites.

The ReBuilder works simultaneously on three separate levels: stimulation of the nerves, stimulation of the muscles, and combined electrostimulation. The first signal is designed to stimulate the nerves by sending an electrical impulse with a very narrow wave-form and a relatively high transient voltage: 40 to 90 volts AC. This signal restores the nerve function and repolarizes synaptic junctions. The second signal stimulates the muscles by a different, wider waveform with a larger subthreshold amount of current under the curve and a much smaller voltage (5 to 20 AC). Simultaneously stimulating the muscles of the feet, calves, thighs, and buttocks, the ReBuilder evokes complete relaxation between each contraction stimulus. This increases the flow of oxygen-rich blood to the synaptic junctions, affording effective and efficient conduction of nerve signals. Combined electro­ stimulation uses twin electrical signals to stimulate the nerves and muscle cells. The manufacturer states that the twin electrical signals cause the brain to release endorphins, inducing a sense of well-being and reducing anxiety as well as physical and emotional trauma. Reduction of pain will lead to improvement in patient compliance and quality of life. Additionally, the ReBuilder features a simultaneous weighted DC signal designed to stabilize the trigger threshold that regulates the sensitivity of the nerve cell. By sending this constant DC signal, the resting potential is held at a fixed voltage long enough for the cell to stabilize itself and regain control.

The ReBuilder is a patient-friendly device that can be used to treat neuropathic pain. It requires a 30-minute treatment window in which the patient applies conductive gel to each of the signal pads. The pads are then placed on the soles of the feet, the palms of the hands, the lower back, or the shoulders, as needed. Pain relief may last for four to six hours after treatment.

Two models are available: the 300 (personal) and the 2407 (clinical). Both contain the electric stimulator; two lead sets and adhesive signal pads. The manufacturer states that the optional footbath improves patient compliance because it delivers the signal across the entire surface of the foot for comfort, causing vaso­dilation within capillaries and increased infusion of freshly oxygenated blood.4 Other application methods are available, such as heated massage boots and conductive socks and gloves. The heated boot vibrates and enables foot elevation.

The 300 personal model is used for moderate neuropathy and has one output. The 2407 clinical model is used for advanced neuropathy and has two separate outputs, affording the patient the opportunity to concurrently treat two areas: the lower back and the feet, especially neuropathy that involves severe numbness. The 2407 model may be beneficial for visually impaired or arthritic patients because of its large adjustment knobs and the large printing on the case.

Efficacy

ReBuilder Medical, Inc. conducted an internal feedback study evaluating 450 cases. This study observed several different factors to determine the success rate in patients, including average pain level, highest level of pain, and improvement in quality of life. Initially and at the end of 10 treatment sessions, the average pain level was calculated. Observations indicate an average reduction in pain by 27.35% and an increase in quality of life by 81.14%. A decrease in symptoms was reported by 95.76% of patients, and 74.56% of patients felt immediate relief after the first session. Currently, several studies of the ReBuilder are ongoing.

Conclusion

Although several pharmacologic modalities may be employed to address neuropathic pain, pain control may not be achieved in all patients. The ReBuilder shows promise for pain mitigation and increased overall quality of life.

References

  1. The Neuropathy Association. Peripheral neuropathy: facts. Accessed June 18, 2007.
  2. Gilron I, Watson CP, Cahill CM, et al. Neuropathic pain: a practical guide for the clinician. Canadian Med Assoc J. 2006;176:265-275.
  3. McCarberg BH, Billington R. Consequences of neuropathic pain: quality-of-life issues and associated cost. Am J Manage Care. 2006;12(suppl 9):S263-268.
  4. SeekWellness. What is the ReBuilder? Accessed June 22, 2004.

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