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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2005 by iTech Medical, Inc..
Recruitment status was  Recruiting
Sponsor:
Information provided by:
iTech Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00134225
First received: August 22, 2005
Last updated: October 25, 2005
Last verified: August 2005
  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)

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Single Blind
Primary Purpose: Diagnostic
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

Resource links provided by NLM:


Further study details as provided by iTech Medical, Inc.:

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
iTech Medical, Inc.
Investigators
Study Director: Alan Goldman, MD Impact Medical Solutions, Inc.
  More Information

Publications:
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).
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).

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

Keywords provided by iTech Medical, Inc.:
Musculoskeletal abnormality
Musculoskeletal physiology
Musculoskeletal disease
Musculoskeletal dysfunction

Additional relevant MeSH terms:
Back Pain
Neck Pain
Low Back Pain
Pain
Neurologic Manifestations
Nervous System Diseases
Signs and Symptoms

ClinicalTrials.gov processed this record on July 29, 2014