Paintronics, Inc

PRESENTATIONMay 2009

Chronic pain is extremely common in our society. In the United States alone, the annual direct costs of its management exceed $150 billion. Studies demonstrate that chronic pain complaints usually depend on a complicated combination of physical, psychobiologic, and socio-dynamic elements. These components dynamically interact to create the pain experience; their magnitude and relations influence the patient’s presentation, prognosis and treatment. It is self-evident that an inaccurate assessment of any problem will impede its resolution. The same holds true for chronic pain complaints. It then follows that if the proper physical substrate is not accurately recognized, then an incorrect treatment will be given. If predominant psychobiologic or socio-dynamic features are not properly identified, then therapeutic failure becomes likely. Better tools are necessary that accurately identify the individual patient’s particular set of pain generators, psychobiological overlays, and socio-dynamic features.

Neurophysiologic Pain Profile [NPP] offers an impartial and objective analysis of all components of the patient’s chronic pain experience. It unequivocally identifies whether the individual’s symptoms are primarily physical, psychobiological, or socio-dynamic in etiology. In most cases, it can determine whether the physical generator is myofascial, neuropathic, ligamentous, or articular.

Introduction

Currently, physicians examine patients clinically by evoking pain symptoms through palpation, range of motion, strength testing, and sensory stimulation. The patient describes the severity of the evoked discomfort by gradations [e.g., mild, moderate, severe, excruciating]. The physician then interprets the patient’s verbal response and other physical responses in an effort to empirically assess the cause and gravity of the problem. This venerable technique holds multiple ambiguities. The patient’s description is the sum total of physical tenderness, emotional responses, and social context. The physician judgments are strongly influenced by training, personal experience, and attitudes. The resulting imprecision can create incorrect medical conclusions leading to over or under-treatment with high cost or ineffective therapies. There is also the problem of factitious behavior and malingering.

The etiology of a patient’s pain symptoms is critical to planning appropriate care. It is illogical to treat a subject with primary depression, anxiety or social problems with protracted physical modalities, increasing narcotics, anesthetic blocks or surgery; it will not work. On the other hand, inaccurately blaming a complaint on depression, anxiety, the wrong medical process, or malingering causes treatment failure that could otherwise be corrected. If a given individual has a chronic pain complaint that can be evoked by a bedside clinical examination, then NPP can reproduce similar test conditions to accurately and unequivocally assess the parameters underlying a patient’s claim of pain. It will do so in a manner that is patient specific, stimulus specific, and tissue-selective.

Overview

The NPP protocol can be separated into two distinct, mutually exclusive time domains:

The Inactive Epochs The Active Epochs

During the test, the patient is connected to the recording monitors. There are rest periods Inactive Epochs when the individual is simply allowed to relax and wait. Then, there are Active Epochs during which the stimulus is applied, OIT is achieved, maintained for three seconds, and removed. Since OIT is a nominal discomfort [as determined by the subject personally], changes usually only occur during the Active Epochs in a purely physical OIT response.

The NPP Protocol

There are three primary PRC patterns commonly seen:

Pure Physical OIT Response

Psychobiological PRC Response

Socio-dynamic PRC Response

When the subject has A Pure Physical OIT Response, the OIT level is lower at the “painful” test site, and the PRC tracings show autonomic/sEMG during the Active Epochs but stability during the Inactive Epochs. A Psychobiological Response demonstrates a great deal of autonomic perturbations during the Inactive Epochs, reflecting anticipatory or reactive non Physical states of stress. A Socio-dynamic Response can be identified when the subject claims OIT level has been achieved, but there is no change in PRC either during the Inactive or Active Epochs.

Patient Response Contour

Neurophysiologic Pain Profile

CLINICAL OVERVIEW

The IASP defines pain as:

“An unpleasant sensory and emotional experience associated with actual or potential tissue damage, or described in terms of such damage.”

In other words, the perception of pain is, in part, a psychological response to noxious stimuli. This definition addresses the complex nature of pain and moves away from the earlier dualistic idea that pain is either psychogenic (of mental origin) or somatogenic (of physical origin). The contemporary view characterizes pain as multidimensional; the central nervous system, emotions, cognitions (thoughts), and beliefs are simultaneously involved.

What is Pain?

1. The Physical Sensorial Tender tissues and the central nervous system physical reactions

2. The Psychobiological Depression and anxiety

3. The SociodynamicLearned personal, cultural, and social attitudes

4. The DescriptionHow someone emotes, exaggerates, or feigns their experience

The 4 Domains of Pain

A Formula Depiction

Σ Physical/Sensorial + Σ Psychobiological +

Σ Sociodynamic + Σ Patient Description =

• If a health professional inaccurately evaluates these four components of a pain complaint, then there will be incorrect diagnoses.

▫ The wrong tissue tenderness will be diagnosed.

▫ The emotional factors may be missed.

▫ The social factors may be missed.

▫ Malingering, exaggeration, stoicism may be missed.

• When the wrong diagnosis is made, the outcome is less certain. Improper treatments will lead to unnecessary suffering; increased disability and impairment; and added social expenses.

NPP Central Proposition

By asking for Pain Threshold more accurately OTI, a precise input can compare complaints of tenderness from one body site to a control site. The subject is his own control.

By recording neurophysiologicoutputs, there is no observer bias. Measuring the temporal and quantitative output, the protocol can distinguish between the domains.

OLD vs. NEWThe VAS question during an

examination does not distinguish between the four domains.

Each clinician who must decipher the VAS-type question relies on his training, bias, personal experience.

The confounding of these matters leads to diagnostic and treatment error.

The Scientific Perspective

NPP Recording Philosophy

• When the nervous system is subjected to sufficient stress, it must respond for ubiquitous reasons of protection and survival.

• This response phenomenon is found in all animals including humans.

• Pain threshold “OIT” is, by definition, a sufficient stimulus to create stress.

Testing Protocal

Test Setup & Preparation

Our testing paradigm begins by taking a directed history focusing on the patient’s pain

syndrome. This identifies the patient’s major painful stimuli and the clinical questions

being addressed. Our procedure thus allows us to individualize the pain syndrome for

each patient to maximize sensitivity and specificity. This allows the selection of the

control and test sites. It also determines the best electrode selection placements.

1.Direct Examination – localizes the site of the major painful foci and the stimulation methods that best evoke the complaints.

2.Electrodes – attached to the subject’s body to monitor a wide variety of physiologic responses.

Surface Electromyogram Activity [sEMG]

Blood Volume Pulse [BVP]

Heart Rate

Skin Conduction Response [SCR]

Accurate Odynic Threshold Stimuli are applied to the subject, at

Which point the protocol selects from several types of quantitative stimuli:

I. Algometry; localized pressure using an algometer

II. Active Range of Motion; ROM using an inclinometer

III.Current Nerve Stimulation; using a peripheral nerve stimulator

IV. Isometric Force – using a force pressure device.

Stimulation Techniques

• After selecting the control and test sites, the stimulation modalities, and placing the electrodes, the protocol begins. The purpose of the test, its performance, and patient participation is explained. The first site tested is usually a “control” site.

• The patient rests; Inactive Epoch data is collected.

• The Active Epochs then begin; the patient presses a button when OIT level is first achieved; this OIT level stimulation is maintained for 3 seconds and the then released; during the active stimulation and a recovery period, data is collected.

• This process is repeated 3 times. The repetition insures that the responses are reproducible and that appropriate parametric statistics can be performed. The entire stimulation process for a site takes about five to seven minutes for data collection. After the first Control site has been evaluated, the process is repeated for the symptomatic Test site. This allows a direct comparison of one body region to another quickly. Depending on the clinical issues, most total tests require that several pairs of sites be tested. The entire test takes usually takes 60 to 90 minutes.

Technician Protocal

• The data from each pair of Control/Test sites is analyzed graphically and statistically from a variety of clinically relevant perspectives. OIT levels are compared to assess the claim of physical tenderness [odynia]. The PRC tracings are graphically analyzed to evaluate physical, psychobiological, and socio-dynamic characteristics. Parametric statistics are done on intra-site perturbations to evaluate whether the graphic interpretation is valid. Parametric statistics are done between Control and Test Sites to evaluate whether the graphic interpretation is valid.

Post-Test Analysis

Data Analysis

Patient Example7/12/2008 – 22:12

A. STIMULATION AND RECORDING DATA: The stimulation modality was Algometry. The Control Site was the Right L. The Test Site was the Left L. Standard recording electrodes were placed as follows for both sites: I. SCR – Left middle and small fingers

II. Plethysmography – Left index finger

III. sEMG 1 – Left Thoracic muscle

IV. sEMG 2 – Right Thoracic muscle. {The last two electrodes were potentially variable}

V. sEMG 3 – Left Lumbar for the Control stimulation and at the Left Lumbar for the Test stimulation

VI. sEMG 4 – Right Lumbar for the Control stimulation and Right Lumbar for the Test stimulation

B. CONTROL SITE RESPONSE DATA: Based on tracings and CV levels, the Control Inactive Epochs PRC [Patient Response Contour] reveals significant perturbations of the following: I. Autonomic Parameters – BVP Amplitude, and Muscles - sEMG1, sEMG4.

The Control Active Stimulation Epochs PRC reveals significant alterations of the following: II. Autonomic parameters – SC, BVP Amplitude & Heart Rate

III. Muscles – sEMG1, sEMG2, sEMG3, sEMG4.

Analyzing The Data

C. OIT DATA: a) Control Site – the mean OIT level was 7.24 kg/cm2

b) Test Site – the mean OIT level was 6.83 kg/cm2 {Based on their mean levels and standard deviations, the OIT values are significantly different}

c) The Control/Test Site OIT – ratio was 1.06

D. TEST SITE RESPONSE DATA: Based on tracings and CV levels, the Test Site Inactive Epochs PRC [Patient response contour] reveals significant perturbations the following:

I. Autonomic Parameters – BVP Amplitude

II. Muscles – sEMG1, sEMG3, sEMG4

Based on tracings and statistical calculations, the Test Active Stimulation Epochsreveals significant alterations of the following: III. Autonomic Parameters – BVP Amplitude, Heart Rate

IV. Muscles – sEMG1, sEMG2, sEMG3, sEMG4

E. INTERSITE COMPARISON: The mean amplitude of response parameters were compared statistically between the Control and Test stimulations. There was a statistically significant greater Test site response for the following: I. Autonomic Parameters – SC, BVP Amplitude, Heart Rate

II. Muscles – sEMG1, sEMG2, sEMG3

Analyzing The Data - Cont.

Clinical Evaluation

The Control Site was the Right L The Test Site was the Left L.

The stimulation modality was ALG The Control/Test Site OIT ratio of 1.06 - {indicates a complaint of no test site odynia}

1) Analysis of the Control Site Activation Stimulation Epochs PRC shows significant alterations of the following autonomic parameters: SC, BVP Amplitude, Heart Rate - consistent with an odynic physiological response.

2) There was an also stimulation-related alteration of the sEMG activity of the following muscles: sEMG1, sEMG2, sEMG3, sEMG4 - consistent with physiological reactive muscle tensing.

3) Analysis of the Control Inactive Epoch PRC reveals significant perturbations involving the following autonomic parameters – BVP Amplitude – is not suggestive of anxiety-related symptom magnification. There was also Inactive Epoch PRC perturbations of the sEMG activity from the following muscles: sEMG1, sEMG4 - suggesting of stimulation-independent guarding.

4) Analysis of the Test Site Activation Stimulation Epoch shows significant alterations of the following autonomic parameters: BVP Amplitude, Heart Rate consistent with an odynic physiologic response. There was an also stimulation-related alteration of the sEMG activity of the Patient – following muscles: sEMG1, sEMG2, sEMG3, sEMG4 - consistent with physiological reactive muscle tensing. Analysis of the Test Inactive Epoch PRC reveals significant perturbations involving the following autonomic parameters: BVP Amplitude – is not consistent with anxiety-related symptom magnification. There was also Inactive Epoch PRC perturbations of the sEMG activity from the following muscles: sEMG1, sEMG3, sEMG4 - suggesting of stimulation-independent guarding.

The Clinical Evaluation

Conclusion

Patient reached MMI she is at very little pain to herupper back she suffered no physical impairment and ADLis achieved with ease. It is my professional opinion thatthe patient can be released from regular care. I haveadvised her that at the event she suffers pain and or herADL is compromised she should resume care.

Overall Conclusion

- Dr. Gady Abramson