Estudio Clínico (Inglés)

New Treatment of Painful Diabetic Neuropathy with Electronic Neuromuscular Stimulator.
By:James R. Arnold D.P.M.
(Extract)

 

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. 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 pathophysilogy of painful diabetic neuropathy. Currently, both pharmacological and nonpharmacological treatment options are available, but unfortunately to date there is no fully effective treatment.

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 their relief of their neuropathic pain symptoms.

Methods

I selected six of my patients who complained about their uncontrolled diabetic neuropathy pain. All patients agreed to keep track of 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. 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 Neurotin 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 a standard 0-10 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 a videotape.

Results

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

Pain levels were reduced in all 6 patients. Original pain levels ranged form 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. No adverse reactions or allergies were reported.

Discussion

There are many advantages of using the electronic neuromuscular stimulator over pharmacological agents for 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 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 has become a popular treatment; however it's 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.

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 for 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

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.

James R. Arnold, DPM
Charles Town, WV