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Cynthia Cernak, DPM , FACFAOM, FACPOPM (1) Robert Odell, MD, PhD (2)

Combination Electroanalgesia Therapy (CET) to Treat Pain Associated with Diabetic Neuropathy Presented to ASRA, April 2010. Cynthia Cernak, DPM , FACFAOM, FACPOPM (1) Robert Odell, MD, PhD (2). ¹Wisconsin Neuropathy, Kenosha, WI ; (2) Neuropathy & Pain Centers of America, Las Vegas, NV .

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Cynthia Cernak, DPM , FACFAOM, FACPOPM (1) Robert Odell, MD, PhD (2)

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  1. Combination Electroanalgesia Therapy (CET) to Treat Pain Associated with Diabetic NeuropathyPresented to ASRA, April 2010 Cynthia Cernak, DPM, FACFAOM, FACPOPM (1) Robert Odell, MD, PhD (2) ¹Wisconsin Neuropathy, Kenosha, WI; (2) Neuropathy & Pain Centers of America, Las Vegas, NV

  2. Introduction • Over 24 million Americans have diabetes and it is estimated that between 40-50 percent of these people will experience some form of nerve damage from their diabetes.¹ • Diabetic Peripheral Neuropathy (DPN) is a major cause of morbidity in patients with diabetes.² • Pain is the most distressing symptom associated with DPN and is potentially disabling.² • Available treatment options offer limited efficacy and potential side effects. • 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 electroanalgesiatreatment (CET).

  3. Combination Electroanalgesia Therapy (CET)Clinical Research: Objective • Goal of Clinical Trial • Understand the safety and efficacy of combining two commonly used approved treatments to manage neuropathy pain in patients • Assess patient adherence to a protocol involving multiple low dose nerve block injections and electricity • Understand the durability of the treatment by following a subset of patients out 1 year post-treatment Cernak, C, Marriott, E., Electric Current and Local Anesthetic Combination Successfully Treats Pain Associated With Diabetic Neuropathy. Practical Pain Mgt. 2012; 8 (4): 23-36.

  4. Methods – Procedures • Protocol: • Patients received 4 weeks of therapy • Each week contains three, 25 minute sessions of electroanalgesia with 2 of 3 sessions including nerve blocks • Injection sites were determined by the peripheral distribution of neuropathic pain. Up to 4 nerves were blocked in the same visit, 1.Sural n, 2. Superficial peroneal n, 3. Deep peroneal n, 4. Saphenous n, 5. Posterior Tibial n. • Pre and post treatment assessments consisting of a VAS (0-10) and a pre and post Pain Questionnaire • Pre and post nerve conduction studies to assess motor and sensory nerves were given to a subset of patients Cernak, C, Marriott, E., Electric Current and Local Anesthetic Combination Successfully Treats Pain Associated With Diabetic Neuropathy. Practical Pain Mgt. 2012; 8 (4): 23-36.

  5. Methods - Patients • Open-label trial containing 114 diabetic patients with peripheral neuropathy with 101 patients evaluated • 58 females and 43 males were enrolled with a mean age of 66.5 and a range of 31 to 87 years. • Ethnicity: 87% Caucasian, 9% Black, 4% Hispanic • 67.7% confirmed Type I or II diabetes and 32.3% were borderline diabetics • Entry criteria – pain symptoms related to diabetic neuropathy • Exclusion Criteria – Pregnancy, Pace makers

  6. Reported Pre-treatment Pain Symptoms *Misc: Achy, Pressure, Weakness, Cold Feet and Fatigue

  7. Methods - Procedures • Subjective: Pre and Post pain assessments were given to each patient. • 1. VAS 0-10 numeric rating • 2. Pain Questionnaire assessing quality of life • Patients who reported pain via VAS score upon completion of protocol had the option of a second course of treatment to further improve the pain response • Objective: Sixty of 101 Patients received pre and post Nerve Conduction Study to measure the effects of treatment on function and ability of electrical conductance of the motor and sensory nerve

  8. Results – Subjective • Average pre-treated pain score was 5.39 and post-treatment was 0.98 (n=101) • 81.8% reduction in pain symptoms • Adjusted pain score • Of 101 patients 31 reported “numbness” or “n/a” when completing VAS. When analyzed “n/a” = 0 • When we evaluated the 70 patients without numbness, pre-treated pain scores rose to 7.79 and post-treatment pain scores were 1.0 • (87.2% reduction in symptoms) • What about the 31 patients with numbness? Cernak, C, Marriott, E., Electric Current and Local Anesthetic Combination Successfully Treats Pain Associated With Diabetic Neuropathy. Practical Pain Mgt. 2012; 8 (4): 23-36.

  9. Patient Response to Pain Scale and Questionnaire 80.2%

  10. Results – SubjectivePatient Response to Second Course of Therapy • Patients that reported improvement but were not considered completely pain free had the option of receiving an additional round of CET. • 23 of 101 patients received an additional course of therapy which resulted in each patient reporting “0” pain on a scale from 0-10. • The subjective questionnaire provided the following improvements in pain: • 15 of 23 patients (65.2%) had a 90 – 99% improvement • 5 of 23 patients (21.7%) had an 80 – 89% improvement • 2 of 23 patients (8.7%) had a 70 – 79% improvement • 1 of 23 patients (4.3%) had a 0-9% improvement

  11. Study Results: Subjective • Post treatment quality of life benefits included: improved pain-free sleeping, balance, walking and enhanced ability to exercise – all reported consistently across gender • Twenty-three (23) patients were evaluated 1 year post-treatment without relapse of pain symptoms and reported improved quality of life . Cernak, C, Marriott, E., Electric Current and Local Anesthetic Combination Successfully Treats Pain Associated With Diabetic Neuropathy. Practical Pain Mgt. 2012; 8 (4): 23-36.

  12. Results – SubjectiveDurability of Effect • Twenty-three of 101 patients are 1 year post-treatment without relapse of pain symptoms. Each is reporting improved quality of life and benefitting from therapy

  13. Post Publication: Patient Durability Original 23 patients re-queried in durability sub-study 41 study patients recently queried (all > 1yr post-treatment) 22 – improved, still no pain after > 1 year 3 – came back over time (pain relief > 6 months) 6 – no long-term benefit (pain relief < 6 months) 9 – Only Short term improvement – ALL of these patients stopped nerve block injections after 2 weeks. 1 - deceased • Twenty-three patients sited in study • 22 are still without pain • 1 relapsed after 18 months

  14. Combined Patient Follow-up (Treatment Durability n=64) • Of 64 patients 44 (68.7%) are out past 1 year with no neuropathy symptoms or pain • Four patients (6.3%) received symptom relief of greater than 1 year but symptoms are retuning • Six patients (9.4%) – received no long-term benefit (pain relief < 6 months) • Nine patients (14.1%) – received short term improvement – ALL of these patients stopped nerve block injections after 2 weeks. • 1 – (1.6%) deceased

  15. Nerve Conduction Study (NCS) Sub-study (n= 60) • Pre and post Nerve Conduction Study (NCS) exams were given to a subset of 60 patients • NCS were given prior to treatment and within one month of completion of the CET protocol • Exams assessed both motor and sensory nerves in which latency, amplitude and velocity measurements were recorded • Fifty-seven (57) patients were evaluated - Three patients discontinued the trial prior to getting their post NCS

  16. Results – ObjectivePatient Response to Motor and Sensory NCS (n = 57)

  17. Results – ObjectivePatient Response to Motor and Sensory NCS Peroneal Motor Peroneal Sensory Sural Sensory Tibial Motor

  18. Results - Objective NCS of Peroneal Motor Nerves • Results of Pre and Post Treatment NCS demonstrated a trend towards increased amplitude and decreased latency of motor nerve function after treatment. • Trends in motor nerve function may represent decline in neurological morbidity of DPN as nerve function improves.

  19. Objective – ResultsNCS of Sensory Nerves • In both sensory nerves tested, the plurality of patients did not have a recordable response both pre and post treatment. • However, over 40% of patients did show improvement in peroneal sensory nerve conduction while more than 31% showed an improvement in their sural sensory nerve. • Further studies are needed to see if the amount of patients that show a response increases with further treatment.

  20. Objective – ResultsBased on Disease Severity • NCS sub-study patients were also assessed and categorized based on disease severity • Mild (n=19) Minimal decreased amplitude and or minimal prolonged latency in the motor and or sensory nerve responses³ • Moderate (n=19) Decreased amplitude and prolonged latencies in the motor and or sensory nerve responses³ • Severe (n=19) No response from both the motor and sensory nerve responses³ • Results indicate that patients who were diagnosed and treated earlier had improved motor and significantly better sensory results Note: Nationally a 5% margin of error is associated with NCS. To reduce variability the investigator ensured that all pre and post tests were completed by the same certified nerve technician with the same machine in the same environment. ³

  21. NCS Results Based on Disease Severity Percent of patients stratified by disease severity that showed improvement after CET

  22. Results – NCS Sub Study • Pre-post Nerve Conduction Studies given to 60 patients (57 could be evaluated as three did not complete post NCS) • Trend toward increased amplitude and decreased latency of motor nerve function • Trends may represent a decline in neurologic morbidity as nerve function improves • Sub-study patients were further characterized by disease severity (mild, moderate and severe) • Results suggest that patients treated earlier had improved motor and significantly better sensory results Cernak, C, Marriott, E., Electric Current and Local Anesthetic Combination Successfully Treats Pain Associated With Diabetic Neuropathy. Practical Pain Mgt. 2012; 8 (4): 23-36.

  23. Conclusion • Patients reported increased pain relief after CET treatment. • DPN patients showed a trend towards improvement in motor nerve function after CET treatment • DPN patients also demonstrated some improvement in sensory nerve function after CET treatment • While more data is needed to further demonstrate improvement, CET appears to positively aid the reversal of sensory and motor nerve pathophysiology in DPN • CET is safe, with risk limited to the local anesthetic injections and no risk from electrical signals. • Patient follow up will be provided to better understand the long-term effects of CET on sensory and motor function

  24. Questions?

  25. CET Discussion • CET is inexpensive and durable • CET is positioned to help patients who are not benefiting from oral medications (Lyrica, Neurontin etc..) • CET is inexpensive and less invasive treatment that should be used prior to schedule II narcotics and surgically implanting a spinal cord stimulator

  26. Back-up Slides

  27. Indentified Mechanisms of Action for the Analgesic Effect of CET 1. Rapidly alternating polarity electrical signals enhances ion movement, balances high differences in metabolites, and promotes pH normalization. 2. Formation of cAMP inhibits arachidonic acid release and subsequent pain mediator cascade. 3. Repeated excitation of afferent fibers interferes with local pain perception (gate-control theory) 4. Induces sustained depolarization which inhibits pain signal transport.

  28. What Do Electrical Currents and Local Anesthetics (CET) Accomplish? • Electrical Currents provide sustained depolarization • Neuron blockade • Afferent blocks result in less perceived pain • Less pain, local muscle relaxation • Relaxation, more circulation • More circulation • More nutrients/enzymes/hormones • Less toxic metabolites • Efferent blocks result in local vasodilation • More circulation • More nutrients/enzymes/hormones • Less metabolites • Less neurogenic inflammation

  29. Chemical Blocks provide hyperpolarization • Neuron blockade • Afferent blocks results in less perceived pain • Less pain, local muscle relaxation • Relaxation, more circulation • More circulation • More nutrients/enzymes/hormones • Less toxic metabolites • Efferent blocks result in local vasodilation • More circulation • More nutrients/enzymes/hormones • Less toxic metabolites • Less neurogenic inflammation Electrical Currents and Chemical Blocks achieve the same physiologic results which provide a synergystic effect with no toxicity!

  30. Electrical Device Provides Both Low and Medium Frequency • Combines Low (LF; <2,000 Hz) and Medium Frequency (MF; 2,000 – 100,000 Hz) • Reaches deeper into tissues by simultaneously modulating frequency between 2,500 Hz and 33,000 Hz and modulating MF down to LF ranges of (0.1  999 Hz) 4) When combining a LF/MF device with local anesthesia the patient receives an enhanced benefit from both modalities with no adverse effects

  31. Nerve Fiber Types and Nerve Blocking Fiber Type Function Diameter Mystification Conduction Sensitivity to (microns) Velocity (m/s) Nerve Block Type A Alpha (α) Proprioception, 12-20 Heavy 70-120 + motor Beta (β) Touch, pressure 5-12 Heavy 30-70 ++ Gamma (γ) Muscle spindles 3-6 Heavy 15-30 ++ Delta (δ) Pain, temperature 2-5 Heavy 12-30 +++ Type BPreganglionic < 3 Light 3-15 ++++ autonomic Type C Dorsal root Pain 0.4-12 None 0.5-2.3 ++++ Sympathetic Postganglionic 0.3-1.3 None 0.7-2.3 ++++ Pain practitioners block the nerves transmitting pain impulses (Type A-δ, Type C) • Lower concentrations of local anesthetic will only block the small unmyelinated and lightly myelinated (Type C and Type A-δ) fibers • Middle-frequency currents (2,000-20,000 Hz) block smaller unmyelinated (Type C) and small myelinated (Type A-δ) fibers • Larger fibers ( Type A-α, β, γ) require high-amplitude currents and are usually spared in electrical, low-dose chemical (eg, labor epidural) blocks

  32. Nerve Block Injections Injection Sites and Protocol

  33. Injection Sites for Nerve Blocks and Protocol Recommendations • Most common nerve injected posterior tibial. Least common deep peroneal. Post tibial has the greatest area of coverage in the foot. Deep peroneal has the smallest area being between 1st and 2nd toes. • Injection 1: Suraln. and Superficial Peronealn. - Pick a point about 4 finger breaths above each maleolus. Lateral and inferior to the tibia insert needle at a 45 degree angle pointing superior and under the tibia. This gets sural. Bring needle back to skin and swing subcutaneous medial. This will get part of superficalperoneal.

  34. Injection Sites for Nerve Blocks and Protocol Recommendations • Injection 2: Posterior Tibialn. and Saphenousn. - Go to medial inferior side of tibia. Insert needle at a 45 degree superior angle under the tibia. This will get post tibial. Bring back to skin and direct subcutaneous lateral. This will pick up saphenous and some superficalperoneal. • The recommended dosage of .25% marcaine and needle size is: Use a 27 g long needle. Inject roughly 1 cc per nerve site. 4 to 5 cc per foot.

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