• Surface sensor EMG collection of muscle recruitment pattern electrical impulses

• Non-invasive

• Based on  widely accepted biomechanical and kinesiological principles

• Objectively  distinguishes between normal quantitative values and “not-normal” quantitative values of muscle function

• Analyzes patterns of interactive and coordinated muscle recruitments (contractions) as the various muscles perform specific body movements in flexion, extension and rotational postures

Clinical Utility

Clinical testing and usage has  shown, and a judicial review has upheld, that the MPR technology is valid, reliable, and safe in objectively and quantitatively assessing neck and back musculoskeletal dysfunctions

• Provides relevant and objective physiologic information that is necessary to accurately diagnose and treat musculoskeletal neck and back dysfunctions such as strains and sprains

• Can assist in resolving disputed,  prolonged and/or expensive cases by giving physicians and other health care providers objective data to support their initial clinical impressions

• Can guide or re-direct physician or health care provider treatments for neck and/or back pain patients with before-and-after objective measurable evidence

• MPR’s ability to quantitatively monitor patient progress during rehabilitative treatments can also help predict if and when the most difficult cases are likely to resolve, which is often a critical issue in case management, case closure, and financial exposure

• The recording hardware used by the MPR System has received Food and Drug Administration (FDA) 510(k) clearance as a recording device and satisfies CE Marking requirements for the European Union

• The musculoskeletal components of the neck and back are complex and interactive in the performance of any given motor task.  The MPR testing modality’s ability to evaluate and measure this complex interactive system provides the basis for a health care provider establishing a treatment protocol.

• Trauma to any component part (muscle, nerve, facet joint, tendon, ligament or other connective tissue) can cause a deficit (loss of biomechanical integrity) in the force-generating potential of the musculoskeletal system

• As a result, conscious or subconscious re-education of the neuromuscular system occurs as a means of adapting or accommodating to the trauma and triggers altered recruitments of motor neuron pools

• MPR testing is non-invasive

• Surface EMG sensors simultaneously record data from seven (7) different muscle groups (14 muscles) of the entire spine (cervical, thoracic, and lumbar regions) during the performance of 9 pre-determined movements

• An individual’s muscle recruitment patterns are then compared, by an elaborately developed computer program, to their respective equivalent patterns derived from a large normative database

• This comparison provides unique, objective information about the biomechanical and kinesiological status of the musculoskeletal system of the neck, mid-, and low back

Preliminary Performance Results

Using the MPR technology to discriminate between a clinically asymptomatic population and one diagnosed with sprain/strain injuries of the neck and back, peer-reviewed publications have reported the following classification performance results for the MPR system:

iTech Medical’s Muscle Pattern Recognition (MPR) test is intended to provide detailed and quantitative physiologic measurements of the musculoskeletal function to assist in the diagnosis and treatment of neck and back dysfunctions.  The MPR technology is non-invasive.  It uses 15 conventional (versus proprietary) surface EMG electrodes placed at pre-specified, measured locations on the patient’s neck, mid-back, and low back. 

The MPR technology analyzes  dynamic muscle patterns of coordinated muscle contractions simultaneously recorded from 7 different muscle groups (14 muscles) as the subject performs 9 pre-defined specific body movements enabling quantitative discrimination between normal and abnormal muscle function, thus objectively characterizing the physical dysfunction associated with neck and back pain.

On the MPR system, those muscle groups that are abnormally weak will contract with a less-than-normal or hypo-kinetic activity.  Those muscle groups that are abnormally active (in spasm) will produce a greater-than-normal or hyper-kinetic activity. These different areas of recruitment are demonstrated on the MPR report, which also designates any interacting or compensating muscle groups in the area surrounding that muscle or group of muscles that are abnormal. This graphic display of muscle abnormality can more appropriately establish a rehabilitative protocol that will strengthen those areas of muscular hypoactivity (weakness) and reduce those areas of muscular hyperactivity.    

Background

Current Unmet Clinical Need

Currently, physicians and other health care providers diagnose and treat patients with back and neck injuries based on indirect, subjective data and a battery of traditional “anatomical” tests which includes:

• CT and MRI Scans
• Plain X-Ray Films
• Needle Insertion Electromyography (EMG)
• Bone Scans
• Physical Examinations
• Myelography

These anatomical studies, however, can show significant abnormalities in individuals who are asymptomatic or have no specific history of neck or back pain.  Large disc herniations, extensive spinal stenosis, and marked degenerative changes can be seen in totally asymptomatic patients and do not correlate well with, or necessarily have any direct relationship to, a patient’s possible pain experience.  These imaging tests may show what exists anatomically,  however, these medically accepted clinical studies of anatomic abnormalities are not always associated with clinical dysfunctions.

These anatomical tests typically do rule-out certain specific pathological causes of pain or dysfunction such as tumors, infections, fractures, or disc herniations, but an accurate, objective diagnosis may still remain unknown for greater than 80% of patients with low back pain.  As a result, many of these individuals with pain remain in the healthcare system far too long and incur unnecessarily high healthcare utilization costs.

iTech Medical has performed  extensive clinical research  that provides evidence that MPR evaluations will allow a physician and other health care providers, for the first time, to actually identify and quantify the specific underlying physiological and biomechanical dysfunctions that correspond to an individual’s subjective complaints or causes of their  functional loss.

In the United States, back pain is the most frequent reason for a visit to a doctor’s office, secondary only to the common cold.  Over 85% of American adults will have neck and/or back pain at some point in their lives and, in this country, such dysfunctions are the leading cause of disability for individuals younger than 45 years of age.  Back injuries are also one of the most expensive healthcare problems for the 20 to 50 year old age group and are estimated to cost in excess of $50 billion per year to the United States economy in direct and indirect costs.  Approximately one-third of all disability costs in the U. S. are due to back disorders.

Currently, physicians and other health care providers diagnose and treat this large segment of the neck and back injured population with indirect, subjective data and a battery of traditional “anatomical” tests such as CT and MRI scans, X-rays, needle insertion EMG, bone Scans, discograms, etc. that will, at best, only rule out certain specific pathological causes of pain or dysfunction such as tumors, fractures, infections, or disc herniations.  Spratt, et al, have commented that an accurate diagnosis is unknown for between 80%-90% of patients with low back pain.[1]  In addition, many of these anatomical image findings can be seen in totally asymptomatic individuals and do not correlate well with, or necessarily have any direct relationship to, a patient’s possible pain experiences.[2] 

These diagnostic imaging tests may show what exists anatomically, but anatomic abnormalities are not always associated with clinical dysfunctions, as many cases of back and neck pains are thought to result from soft tissue injuries that implicate muscles, tendons, and/or ligaments.  Unfortunately, without definitive tests or other objective assessment tools, health care providers must base their diagnoses and treatment decisions on subjective data that may be open to possible differing interpretations by other such providers.