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

Purpose

The investigators hypothesize that non able-bodied participants with reported acute, sub-acute, or chronic symptoms of neck or back pain of a musculoskeletal origin will have magnetic resonance imaging (MRI), X-ray and blood parameters that do not demonstrate a statistical difference between “normal” (able-bodied) volunteers.

Muscle pattern recognition (MPR) testing will show statistically different results between these groups. This statistically significant finding in MPR results will enhance a clinician’s determination of clinical normality or abnormality.

If this hypothesis is demonstrated, the MPR modality will be the first quantitative tool developed for assisting in the diagnosis of the presence or absence of a musculoskeletal dysfunction in a patient population. The availability of such an evaluation tool to a healthcare provider for patients with soft tissue, non-surgical neck or back complaints will substantially improve the accuracy of diagnosis and case management decisions.

Condition	Intervention
Neck Pain Low Back Pain	Device: Muscle Pattern Recognition (MPR)

MedlinePlus related topics:

Back Pain Neck Injuries and Disorders

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Diagnostic, Non-Randomized, Single Blind, Active Control, Single Group Assignment, Safety/Efficacy Study

Official Title:	Multi-Center, Multi-National Study to Demonstrate That Muscle Pattern Recognition is a Reliable and Valid Evaluation Tool for Patients Who Present With Acute, Sub-Acute, or Chronic Symptoms of Neck or Back Pain of a Musculoskeletal Origin

Further study details as provided by Impact Medical Solutions:

Primary Outcome Measures:

This study will demonstrate differences in muscle recruitment patterns between individuals who are “normal” (asymptomatic, able-bodied) from those individuals (“not normal”) with underlying biomechanical dysfunction of the neck and back

Estimated Enrollment:	480
Study Start Date:	April 2005
Estimated Study Completion Date:	December 2006

Show Detailed Description

Eligibility

Ages Eligible for Study:	18 Years to 62 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00134225

Contacts


Contact: Suzan D Olson, PhD, MHS, RN	269.329.3517	solson@midwestcct.com

Contact: Leslie Johnson	269.329.3517	ljohnson@midwestcct.com

Locations


United States, California
	Department of Neurology - UC Irvine	Not yet recruiting
	Irvine, California, United States, 92697-4275
	Contact: Neal Hermanowicz, MD
	Contact: Shari Niswonger 949-824-8116
	Principal Investigator: Neal Hermanowicz, MD
	Sub-Investigator: Ted Field, MD

United States, Michigan
	Midwest Consultants for Clinical Trials LLC	Recruiting
	Portage, Michigan, United States, 49002
	Contact: Suzan Olson, PhD 269-329-3517 solson@midwestcct.com
	Contact: Gail Massey, RN 269-329-3517 ext 522 gmassey@midwestcct.com
	Principal Investigator: Mark Noffsinger, MD
	Sub-Investigator: Thomas Ryan, MD
	Sub-Investigator: Brian Visser, MD
	Sub-Investigator: Augustus Guerrero, MD
	Sub-Investigator: Todd Ream, MD

United States, Utah
	Advance Clinical Research	Not yet recruiting
	Salt Lake City, Utah, United States, 84102
	Contact: Mark Passey, MD 801-355-4126
	Contact: Kristi Newingham 801-355-4126 ext 110 knewingham@acr-research.com
	Principal Investigator: Mark Passey, MD
	Sub-Investigator: Warren Stadler, MD

Canada, Quebec
	Institute de Rescherche in Physiatrie du Quebec	Not yet recruiting
	Montreal, Quebec, Canada, H2K 1C1
	Contact: Genevieve Bujold 514-527-4155 rabyr@videotron.ca
	Principal Investigator: Luc Fortran, MD
	Sub-Investigator: Guy Bouvier, MD

Sponsors and Collaborators

Impact Medical Solutions

Investigators


Study Director:	Alan Goldman, MD	Impact Medical Solutions, Inc.

More Information

Publications of Results:

V.R. Edgerton, S.T. Wolf, D.J. Levendowski, and R.R. Roy (1996). Evaluating Patterns of EMG Amplitudes for Back and Trunk Muscles of Patients and Controls. International Journal of Rehabilitation and Health, 2(1).

Edgerton VR, Wolf SL, Levendowski DJ, Roy RR. Theoretical basis for patterning EMG amplitudes to assess muscle dysfunction. Med Sci Sports Exerc. 1996 Jun;28(6):744-51.

Other Publications:

VR Edgerton, SL Wolf, DJ Levendowski, RI Jenrich, RR Roy (1997). EMG activity in neck and back muscles during selected static postures in adult males and females. Physiology theory and practice. 13:179-195.

VR Edgerton, SL Wolf, DJ Levendowski, RL Roy (1996). Evaluating Patterns of EMG Amplitudes for Trunk and Neck Muscles of Patients and Controls. International Journal of Rehabilitation and Health, 2(1).

Study ID Numbers:	IMS MPR 480
First Received:	August 22, 2005
Last Updated:	October 25, 2005
ClinicalTrials.gov Identifier:	NCT00134225
Health Authority:	United States: Institutional Review Board

Keywords provided by Impact Medical Solutions:

Musculoskeletal abnormality

Musculoskeletal physiology

Musculoskeletal disease

Musculoskeletal dysfunction

Study placed in the following topic categories:

Signs and Symptoms

Musculoskeletal Diseases

Neck Pain

Neurologic Manifestations

Low Back Pain

Pain

Congenital Abnormalities

Back Pain

Musculoskeletal Abnormalities

Additional relevant MeSH terms:

Nervous System Diseases

ClinicalTrials.gov processed this record on October 17, 2008

Sponsored by:	Impact Medical Solutions
Information provided by:	Impact Medical Solutions
ClinicalTrials.gov Identifier:	NCT00134225