ReBuilder Effectiveness with 134 patients

Author: Dr. Karlock DPM, David B. Phillips, Ph.D.

Abstract:

134 patients with peripheral neuropathy of various etiologies were treated for 30 days.

Treatment of painful neuropathy has become a mainstay in the practice of foot and ankle specialties. According to the World Health Organization an estimated 220 million people were diagnosed with diabetes mellitus in 2010. There are approximately 16 million people with diabetes mellitus in the United States today and painful diabetic neuropathy has been reported to affect nearly 50% of the people with diabetes along pharmacological and non pharmacological agents as well as nerve decompression surgeries.

In this study, the authors have used the ReBuilder unit (Fig.1) to determine its' effectiveness in treatment of painful neuropathy. The Builder treatment system has been designed to re-polarize nerves as well as to enable nerve impulses to jump synaptic junctions, reconnect the injured nerve cells, restore blood circulation and promote new nerve growth which eventually should reduce pain symptoms. Judicious and frequent use of the ReBuilder may even slow down the progression of neuropathy and aid in even reversing neuropathy. The ReBuilder unit provides a nerve signal which it sends from one foot, up the leg, across the nerve roots of the lower spine to the contra-lateral leg leading to the contra-lateral foot after which the signal travels in reverse. The ReBuilder has an automatic microprocessor feedback circuit that essentially adjusts itself 7.83 times per second to fit the patient's changing nerve impulse parameters.

In this study, the authors examine the degree of symptomatic relief from neuropathic pain symptoms with the use of the ReBuilder in private practice.

Method and Data Collection:

Over two years (2010,2011, 134 patients, age ranges of 45-90 years, who complained of pain associated with neuropathy symptoms were dispensed the ReBuilder for a one month trial, using the unit unsupervised, at home. Patients could choose to purchase the ReBuilder after a one month trial if the patients found acceptable relief from neuropathy symptoms and pain. Each patient was instructed on how to administer the ReBuilder for 30 minutes each.

All patients agreed to monitor their pain level and neuropathy symptoms everyday by using the Numeric Rating scale designed by National Institutes of Heath Warren Grant Magnuson Clinical Center which measures pain on a scale of 1-10 (rating of 1 for mild pain and rating of 10 for severe pain).

Those patients who had purchased the unit for long term after the 30 day trial agreed to continue to document their experience every day for an average of 6 months using the Numeric Rating Scale. No new treatment regiment was added within 30 days of the initial use of the TENS unit and concurrent use of pharmacological agents such as Lyrica, NSAIDS, and Gabapentin were not an excluding criteria from participation in the study.

Patients were then divided into four groups based on the disease processes that lead to pain and neuropathy symptoms:

1. Peripheral Vasclar Disease (PVD with average range of diagnosis of 15 years), Diabetes Mellitus (DM with average range of diagnosis of 23 years)
2. Diabetes Mellitus
3. Alcoholism (with average range of diagnosis for 10 years), Diabetes Mellitus
4. Concurrent Chemotherapy treatment for cancer (with average treatment plan of 2 months)

The patients were then assessed for the amount of time the patients had used the ReBuilder unit, the average decrease in the pain score, the rate of returned ReBuilders due to the failure of unit to provide continuous relief from neuropathic pain and any further surgical treatment that patients received after they returned their Rebuilders (fig. 2).

Results:

The data was analyzed using the Kruskal-Wallis test to analyze variance in the results as well as to determine whether our data was statistically significant.

Patients with PCD, DM noted an average decrease of pain of 8.08% (standard deviation of 7.93%) with 21 of the 44 patients returning the unit due to failure of the ReBuilder unit to relieve the painful neuropathy symptoms (fig. 3). Out of those patients who returned the unit, five of the patients underwent triple nerve decompression surgery which ultimately provided the patients with some relief form painful neuropathy symptoms.

Patients with Diabetes Mellitus were noted to have a return rate of 21 units and 42 of the 60 patients continued to use the unit with an average pain score decrease of 16.60% (standard deviation of 22.77%) with further surgical treatment of eight patients with triple nerve decompression (fig. 3).

Patients with Diabetes Mellitus and Alcoholism noted an average decrease in neuropathy symptoms of 6.02% (standard deviation of 5.69%) with half the patients returning the unit (fig 3).

Patients with concurrent chemotherapy treatment noted a decrease of 12.54 (standard deviation of 14.44%) with eight patients returning the unit and twelve patients still using the unit. It is important to note that results for patients with DM and DM, PVD as well as DM and DM, Alcoholism were statistically significant with p < 05 respectively.

Patients were also asked to rate their pain subjectively using the by using the Numeric Rating scale designed by National Institutes of Health Warren Grant Magnuson Clinical Center.

Patients with DNM reported an average decrease in pain score from 8/10 to 6.2/10 (fig.4).

Patients with alcoholism and DM and PVD reported an average decrease in pain score of 8/10 to 7.3/10 (fig 4).

Patients with alcoholism and DM reported an average decrease in pain score of 8.9/10-8.4/10 (fig 4).

Patients undergoing chemotherapy reported an average decrease in pain score of 8.9/10 to 7.6/10 (fig 4).

Discussion:

According to the data, patients with DM and PVD, and DM with Alcoholism seemed to obtain the least amount of relief from painful neuropathy symptoms. Patients with DM and patients undergoing concurrent chemotherapy treatment achieved the most of pain relief as well as symptomatic relief from neuropathy.

Very few patients underwent surgical triple nerve decompression, but most patients who chose to opt out of any surgical nerve decompression did so because of ambivalence of surgery and because they expressed that the amount of relief from painful neuropathy symptoms they acquired meet their expectations. A very important point of note is that majority of the patients who kept the unit for an average of 6 months, expressed that they had to use the ReBuilder TENS unit everyday in order to obtain relief from neuropathy symptoms. When the patients stopped using the unit for an average of five days, the painful neuropathy symptoms had returned to the pain level of pre-TENS unit use.

To our knowledge, only one other study has been performed specifically to determine the decrease in neuropathy pain symptoms for patients with Type 2 Diabetes. James Arnold, a podiatrist, conducted an in-house study with six patients affected by peripheral neuropathy due to Type 2 Diabetes. Dr. Arnold treated his patients personally rather than sending them home to treat themselves.

Dr. Arnold reported a 5 point (greater than 50%) decrease in pain on average for all patients using a pain scale of 1-10 with 10 as a subjective measurement of severe pain.

Patients were followed for 8 weeks and it was concluded that the neuropathic pain symptoms were decreased by 52%-64%.

Our results, however, differ from Dr. Arnold's study. Our results varied possibly due to the fact that our study conducted a much larger sample size with patients with diabetic neuropathy as well as other pathologies that complicate diabetic neuropathy. Another factor was that we did no counseling, nutritional support and did not personally supervise the treatments. We also had the opportunity to follow patients on an average of 6 months as opposed to 8 weeks. And of course, pain scale measurements are a subjective analysis; therefore, our results are based on patients' own analysis of pain. Dr. Arnold's study was based on what the patient reported to the physician immediately after their treatments.

Additionally, the factor of money entered here. The patients who choose to keep the unit had to pay for it ($1,000), so therefore if they got enough benefit they did not need the unit anymore, or if they did not have the money to pay for it, they returned it. At the time oaf this study Medicare was snot in place to cover the ReBuilder. Now patients can have Medicare pay for it and we suspect that the return rate would now be close to zero.

Another cause for returns was the fact that many of these patients had other medical issues that complicated the treatments. Another consideration is that all these patients used the twin compartment footbath, which has since been replaced with conductive garments. The water bath was difficult to manage, and many times required the help of others I the family. The garments now make it easier to use.

One of the main advantages of the ReBuilder unit is the ease of use of the unit as well as the fact that the unit does not interfere with any concomitant pharmacological therapy. However, one of the disadvantages appears to be that the ReBuilder unit may have to be used daily to achieve and maintain pain relief form neuropathy symptoms.

When the unit is no longer used, our patients experienced the return of painful neuropathy symptoms. The ReBuilder TENS unit may very likely slow the progression of pain and neuropathy symptoms, but when used as our patients used it, that is as a sole modality, it does not seem to reverse the symptoms after the use of unit has been stopped.

Nerve fiber density biopsy test before and after the use of the ReBuilder unit, therefore, may be a good indicator of whether the progression of neuropathy has been delayed or even reversed. Future studies may benefit from adding this objective measurement.

Further studies of the ReBuilder can focus on pain and neuropathy symptom relief from the use of just pharmacological agents versus neuropathy symptoms relief from the just the ReBuilder alone as well as differences in pain and neuropathy symptom relief in controlled and uncontrolled diabetics.

Conclusion:

The ReBuilder TENS unit provides acceptable pain and neuropathy symptom relief for patients with VD, DM, Alcoholism and Chemotherapy agents and is very easy for patients to self-administer.

The ReBuilder unit does not interfere with patients' current use of pharmacological agents.

According to the data in this study, the ReBuilder unit may have to be used continuously to achieve pain and neuropathy symptom relief and should be studied further to analyze whether painful neuropathy is actually reversed by the ReBuilder unit, and what amount of personal involvement with the physician, technician, Physical therapist, etc is most helpful for the greatest clinical outcomes.

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