Study to Demonstrate That Muscle Pattern Recognition (MPR) is an Effective Evaluation Tool for Musculoskeletal Neck or Back Pain

Investigators aim to use data from both the able-bodied and non able-bodied samples to
create a normative database for this technology. The primary objective of populating a
normative database will be to construct a reliable and valid normative database
representative of the North American population for use with a discriminative analysis tool
which will differentiate abnormal musculoskeletal function from normal musculoskeletal
function.

Study Population: The study population will be composed of 480 asymptomatic participants
(able-bodied individuals) and symptomatic (non able-bodied individuals: individuals with
musculoskeletal, non-surgical injuries of the neck and back) selected first on the basis of
a screening questionnaire.

Upon signing an informed consent to participate in the study, participants will complete
screening questionnaires. They will be independently evaluated by two clinicians, well
experienced in the field of musculoskeletal medicine, who obtain a detailed medical history
with particular attention to the strict inclusion/exclusion criteria and perform a
standardized physical examination. This standardized clinical examination consists of the
most current “Gold Standard”.

Most patients presenting with musculoskeletal complaints of the back or neck and are
frequently given this diagnosis solely on the basis of the “first line” healthcare
providers’ history and physical examinations.

To ensure the statistical strength of the history and physical selection process for further
inclusion into the study, participants will undergo two separate clinical examinations. Each
will be performed independently by physicians who are specialists in two different fields of
practice that commonly see neck and back pain patients and who must agree if a subject is
clinically normal or not.

If selected for continued participation, each participant will undergo Magnetic Resonance
Imaging (MRI) of the spine (sagittal views of the entire spine), plain X-rays of the entire
spine (A/P and Lateral views), blood studies (CBC, Sedimentation Rate, CPK, Calcium,
Phosphorous, Pregnancy test, drug screen) and MPR testing.

A total of 480 clinically and lab normal able-bodied/not-able bodied individuals will be
selected and examined over a period of twelve months at 4 different centers.

Able-Bodied Participants:

A total of approximately 240 able-bodied participants will be divided by gender (male,
female) and by age classes: specifically [18-30 years], [31-45 years], and [46-62 years].
This sample size was selected, in part, because Edgerton et al. reported that recruitment
patterns of the neck or back differ dependent upon gender and our goal is to have a
population of approximately 120 males and 120 females.

At the close of the study, investigators will segment the population into the three age
groups mentioned, the proposed sample sizes are thought to be appropriate for statistical
analysis while still capturing a variety of subject types. The overall age range was chosen
to represent the main working population in North America, but to not exceed an upper age
range where muscle recruitment patterns may vary on a natural evolutionary basis.

The total number of normal/able-bodied participants will be collected from 4 independent
research centers in the U.S. and Canada with an expected maximum of approximately 60
individuals per center. A sub-group of 32 randomly assigned able-bodied volunteers will be
scheduled for a second MPR test approximately 7 days after their initial testing to examine
the reliability of the MPR evaluation tool. In the selection process, every effort will be
made to avoid bias toward a non-working population (i.e. testing only in the morning or
afternoon) and to obtain representative proportions of the age and race classes existing in
North America.

Not Able-Bodied Participants:

Investigators aim to construct a valid and reliable profile of clinically not normal
individuals diagnosed as suffering from musculoskeletal neck or back pain that will be used
to confirm our hypothesis and the ability of the MPR evaluation to provide valid, reliable,
and objective information for the clinician.

These 240 not able-bodied volunteers will be selected using the same inclusion/exclusion
criteria and standardized medical histories and physical examinations as above. One
exception to the exclusion criteria is that if a not-normal participant uses ongoing
medications for control of discomfort, it will be left to the discretion of each
investigator as to how that individual’s medication profile may affect their pain reporting,
physical performance, or compliance with the protocol steps. A 3-day medication “wash-out”
will be allowed (and encouraged) if there is any concern about a participant’s performance.

In order to conduct an appropriate discriminate analysis, half of the recruited participants
will be an able-bodied sample of participants. Half of the participants will fall into the
not able-bodied participant sample. Every effort will be made in the selection process to
avoid bias toward a non-working population (i.e. testing only in the morning or afternoon)
and obtain representative proportions of the age and race classes existing in North America.

During the data collection process, other clinical categories could be defined for
additional statistical analysis such as the loci of symptoms (i.e. lumbar, thoracic,
cervical), the level of symptoms (lower, mid, or upper back) and the laterality of symptoms
(left or right). Upon analysis of the laboratory and image findings (MRI, X-ray, blood
tests) other anatomic findings or variations such as degenerative disc disease, size of
possible disc protrusions, Sedimentation Rate or CPK values, Schmorld’s nodes, etc. may also
be discussed.

Not able-bodied volunteers may have long standing back or neck pain or pain symptoms as
recently as several days after a date of injury. This more immediate window of pain will be
allowed to include acute events but not until or unless the individual is able to perform
the nine movements necessary for the MPR testing procedure. The outer time duration of pain
was chosen to include individuals with more chronic complaints, but not if other
compensatory or secondary gain issues appear present such as may occur with Worker’s
Compensation claims, disability claims, or litigation. It is the desire of investigators to
include appropriate acute, sub-acute, and chronic neck or back pain sufferers.

We believe that the design of this study will prove that the evaluation provided by the MPR
testing modality should be the tool of choice for the objective evaluation and case
management of patients presenting with musculoskeletal, non-surgical neck and back pain as
it will differentiate “normal” (asymptomatic, able-bodied) individuals from those
individuals (“not normal”) with underlying biomechanical dysfunctions.

Inclusion Criteria:

Individuals may participate in this study if they meet the following criteria:

- 18-62 years of age; male or female.

- 4 foot 10 inches to 6 foot 5 inches in height

- No prior back or neck surgery, or structural deformity of the spine

- No orthopedic injury/illness/surgery limiting range of motion of the shoulders

- No ongoing treatments for back or neck pain/injury from a health professional in the
last two years.

- No prior loss of work time due to a neck or back injury/illness

- Laboratory studies: complete blood count (CBC); sedimentation rate; creatinine
phosphokinase (CPK); calcium; phosphorus; pregnancy test if female; and drug screen.
Laboratory studies will be examined by a physician investigator to determine if the
findings will exclude the participant from participating successfully in study
activities. A positive pregnancy test or drug screen will automatically exclude the
participant from the study.

- Clinical examination of the neck and back by two physicians in agreement that the
participant may participate in the study.

- Absence of congenital or acquired neuromuscular disease or dysfunction

Exclusion Criteria:

Individuals may not participate in this study if they meet the following criteria:

- Claustrophobia or anxiety associated with being enclosed in narrow spaces

- Muscle weakness or sensory feedback abnormalities that affect(s) gait

- Pregnancy

- Concurrent serious medical illness such as cancer; recent heart attack or stroke;
heart rhythm disturbance requiring a pacemaker; diabetes that causes pain; numbness;
or decreased circulation in the legs.

- Alcohol or illicit drug abuse.

- History of (or concurrent) psychiatric illness necessitating ongoing “talk” therapy
and/or psychotropic medications

- History of back or neck pain lasting more than 3 days or requiring time off of work
AND healthcare provider treatments within the last 2 years

- Involved in a lawsuit or receiving worker’s compensation or disability payments

- Individuals with pacemakers or pacemaker wires; aneurysm clips; or metallic foreign
bodies or metal shavings in the body.