New Treatment of Painful Diabetic Neuropathy with the ReBuilder Electronic Neuromuscular Stimulator

James R. Arnold D.P.M.

Abstract:
Six patients with diagnosed neuropathic pain due to type 2 diabetes were given a novel electronic stimulator (ReBuilder, www.ReBuilderMedical.ca) and treated themselves once daily for 30 minutes. Patient compliance was very high and all six patients reported significant relief (average 40%) from neuropathic pain.

Introduction
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. Diabetic polyneuropathy has been reported to affect nearly 50% of the people with diabetes. (1) The neuropathy is associated with pain in approximately 10% of those patients. Although studies show a relationship between hyperglycemia and the development and severity of diabetic neuropathy, researchers are still unraveling the exact pathophysiology of painful diabetic neuropathy. Currently, both pharmacological and non pharmacological 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:

  • ease of use
  • tolerability
  • symptomatic relief of neuropathic pain symptoms

Methods
I selected six of my previously diagnosed diabetic patients who complained about their uncontrolled diabetic neuropathy pain. All patients agreed to use the ReBuilder unassisted at home for 8 weeks and keep track of and report their results. Concurrent use of pharmacological therapy was not an exclusion factor; however, no new treatment regime was added within 30 days of starting the neuromuscular stimulator. The test group was divided evenly between Insulin and non-insulin dependent diabetics. Their 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. Data recording was stopped at 8 weeks.

Pain level was assessed with standard 1-10 pain scale with 0 being no pain and 10 being intolerable pain.

The patients were given a 15-minute instructional session on using the stimulator and the videotape.

How the ReBuilder's signal is administered
The ReBuilder is registered with the FDA under dual 510K submissions(1987), one for TENS and one for EMS, and has a reported distribution in excess of 70,000 worldwide.

It differs significantly from a common TENS in that a TENS device blocks a nerve path while the ReBuilder opens nerve paths. The ReBuilder provides an exact copy of a healthy nerve signal (like a heart pacemaker copies a healthy heart signal) and then after amplifying it by a factor of 10, sends that signal from one foot, up the leg, across the nerve roots of the lower spine, then down the contra-lateral leg to the contra-lateral foot and then reverses itself. The treatment lasts for 30 minutes and the device automatically shuts down and resets. The ReBuilder has an automatic microprocessor feedback circuit that adjusts itself 10 times per second to fit the patient’s changing nerve impulse parameters. The patient feels a comfortable pulsating tingling feeling. This signal has the additional effect of causing the brain to release endorphins and helps the patient’s mood and helps the patient to relax.

To use, the patient fills 2 shoe box sized plastic containers ankle deep with warm tap water and adds a teaspoon of provided electrolytic salts to make the water conductive and to help heal occult skin infections for diabetics. The patient places a signal pad into each container and then places his feet into each of the containers. Sitting comfortably in an easy chair, the patient turns on the on/off intensity knob on and then increases the intensity of the signal until he feels a comfortable tingling.

When finished, the patient towel dries his feet, empties the water, washes out the containers and stores the system in the containers for its next use.

Results

Patient
Age
Gender
Initial Pain Level
2 week level
8 week level
% reduction in pain
1
55
M
9
5
3
66.7
2
76
M
8
5
3
62.5
3
57
F
7
4
3
57.1
4
67
F
9
7
6
33.3
5
62
M
8
4
2
75.0
6
45
F
8
6
3
62.5
49
31
20
59.5

All six patients found the device easy to use and stated the original 15-minute demonstration and video was enough instruction. All patients finished their eight week study and were planning on continuing use of the ReBuilder. All patients reported muscular contraction in their calf muscles at a comfortable setting.

Pain levels were reduced in all 6 patients. Original pain levels ranged from 5 to 10. The average reduction on the pains scale was three levels after two weeks and five levels by the end of the study.

One incidental, anecdotal finding was that four of the patients had trouble falling to sleep before the study and all 4 noted improvement within two days of starting the ReBuilder

No adverse reactions or allergies were reported.

Discussion
There are many advantages of using the electronic ReBuilder neuromuscular stimulator over pharmacological agents for treatment of painful diabetic neuropathy.

Pharmacological therapy includes tricyclic antidepressants which have been long considered the standard for chronic diabetic nerve pain, and provide significant pain relief to 30% of patients with neuropathic pain. Unfortunately, most patients experience intolerable adverse effects such as sedation, dry mouth, urinary retention, orthostatic hypotension or cardiac arrhythmias. Narcotic analgesics are 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 its high price often makes it cost prohibitive and its side effects are considerable. Dizziness was reported in 24% somnolence in 23%, headache and diarrhea in 11% of patients. Care must be taken with the antiarrhythmics, and serum level monitored. (3)

The ReBuilder electronic neuromuscular stimulator provides an easy to use, no 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.

Conclusion
The ReBuilder electronic neuromuscular stimulator was easy to use and shows promise as a well tolerated, effective treatment for painful diabetic neuropathy.

James R. Arnold, DPM
Charles Town, WV

References:

1) Polydefkis M, Griffin JW, Mc Arthur J. New insights into diabetic polyneuropathy. JAMA. 2003 Sep 19;290(10)1371-6

2) Backonja M. Managing painful diabetic neuropathy. Hosp Pract (Off Ed). 1999 Oct 15;34(11):79-82,83-8

3) Winik Al. Diabetic neuropathy: pathogenesis and therapy. Am J Med.1999 Aug 30;107(2B):17S-26S

4) Barbano RL, Hermann DN, Hart-GouleauS, et al. Effectiveness, tolerability and impact on quality of life of the 5%lidocaine patch in diabetic polyneuropathy. Arch Neurol. 2004 Jun;61(6):914-8.

5) Huges RA. Peripheral neuropathy. Geriatrics 2003 Jun:58(6):16-8,24-5,30.

6)KlineKM, Carroll DG, Malnar KF. Painful diabetic peripheral neuropathy relieved With use of oral topiramate. South Med J. 2003 June;96(6):602-5.

 

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