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

It is estimated that 10 to 20 million Americans suffer from neuropathy.¹ 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 undertreated 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. ²

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.³

The ReBuilder
The ReBuilder is a noninvasive hand-held device approved by the FDA for the treatment of pain (see Figure 1).⁴ 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 (see Figure 2).⁴ 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).⁴ 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.⁴ 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.⁴

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 (see Figure 3).⁵ Pain relief may last for four to six hours after treatment.

Two models are available: the 3000 (personal) and the 2406 (clinical)(Now 2407). Both contain the electric stimulator; two lead sets and six adhesive signal pads; a twin-compartment footbath; Cooling Cream; Electrolyte; Epsom salts; and two nonadhesive pads for use with the footbath. The manufacturer states that the footbath improves patient compliance because it delivers the signal across the entire surface of the foot for comfort, causing vaso­ dila­ t- a­ tion 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.⁴

The 3000 personal model is used for moderate neuropathy and has two separate outputs, affording the patient the opportunity to concurrently treat two areas: the lower back and the feet. Patients with chronic lower-back pain and muscle spasms may prefer to use the 3000 model because of its portability and convenience. The 2406 (Now 2407) clinical model is used for advanced neuropathy, especially neuropathy that involves severe numbness. The 2406 (Now 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.⁶

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. Available at: www.neuropathy.org/ site/PageServer?pagename=About_

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. ReBuilder Medical Technologies, Inc. Available at: www.rebuildermedical.com/. Accessed June 1, 2007.

5. SeekWellness. What is the ReBuilder? Available at: www.seek wellness.com/conditions/diabetes/rebuilder.htm. Accessed June 22, 2004.

6. ReBuilder Internal Studies. Customer service department. Available at: www.rebuildermedical.com. Accessed June 21, 2007.