Abstract Title: Combination Electrochemical Therapy (CET) to treat Patients with Diabetic Neuropathy

Authors: Cynthia R Cernak, DPM, Kenosha , WI
Robert H. Odell, Jr., MD, PhD, Las Vegas, NV; Elizabeth Marriott, MD, Milwaukee, WI; Briana Silvani, R.NSC.T, R.EDT, Kenosha, WI

ABSTRACT BODY

Background: Diabetic Peripheral Neuropathy (DPN) is a major cause of morbidity in patients with diabetes. Available treatment options offer limited efficacy and potential side effects.This growing problem requires new approaches.

Electronic signal treatment (EST) utilizes computer controlled, exogenously delivered specific parameter electroanalgesia using both varied amplitudes and frequencies of electronic signals. EST is delivered with local anesthetic injections, termed combination electrochemical treatment (CET). CET is effective to treat neuropathic pain related to DPN.

CET suppresses axonal pain signals both electrically and chemically, decreases peripheral sensitization to break the pain cycle, facilitates and optimizes normal metabolic and reparative processes, suppresses edema,reduces inflammation,improves circulation, decreases central sensitization by altered gene expression in dorsal horn neurons and supports the immune system.

Objective: To evaluate safety and efficacy of CET in DPN patients

Methods: 32 DPN patients were enrolled in an open-label trial that combined peripheral nerve injections using 0.25% marcaine with patented programmed electroanalgesia described above. Patients received 4 weeks of therapy,each week containing three 25 minute sessions of electroanalgesia with 2 of 3 weekly sessions including nerve blocks.

Results: 19 males and 13 females were enrolled with a mean age of 69.4. Patients complained of sensory pain including numbness, tingling, RLS and burning pain that limited daily activities. 24 of 32 patients evaluated reported a mean reduction of symptoms from baseline of 49%. 8 patients (25%) reported no relief.Post-treatment quality of life benefits included improved pain-free sleeping, balance, walking and enhanced ability to exercise.Pre and post Nerve Conduction Velocity (NCV) exams were given to a subset of 10 patients.These case studies document improvement of NCV studies after 4 weeks of CET.Some patients demonstrated recordable motor nerve conduction amplitudes.No patients suffered any adverse effects.

Discussion: Pre and post treatment NCV has shown measurable objective improvement,findings which the authors believe offer substantive proof of the potential for this technology.While more data is needed the CET protocol appears to treat the underlying causes of DPN and positively aids in the reversal of sensory and motor pathophysiology.

Most neurologists agree that the main pathophysiology of nerve damage due to diabetes includes axonal nerve damage.CET seeks not only to relieve patient discomfort due to the painful neuropathy, but also to help restore nerve function.In some patients there was recordable improvement in the amplitude of motor nerve conductions,indicating improvement of axonal function,thus improvement in motor function and decreased neurological morbidity. CET is safe,with risk limited to the local anesthetic injections,with no risk from the electrical signals.

Conclusion: DPN patients showed marked symptom and motor function improvement with this safe technology.Patient follow-up will be provided to better understand the long-term effects of CET on sensory and motor function.The outcomes discovered are exciting since there are limited treatment alternatives.

ATTACHED FILES

Reg Anesth Pain Med 2010; 51