Recruiting

Muscle Pattern Recognition

Sponsor:

iTech Medical, Inc.

Code:

NCT00134225

Conditions

Neck Pain

Low Back Pain

Eligibility Criteria

Sex: All

Age: 18 - 62

Healthy Volunteers: Accepted

Interventions

Muscle Pattern Recognition (MPR)

Study Details

Brief summary:

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.

Conditions

Neck Pain

Low Back Pain

Study ID

NCT00134225

Start date

Apr, 2005

Status verified date

Aug, 2005

Completion date

Dec, 2006

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 62

Healthy Volunteers: Accepted

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.

Study Design

Enrollment

480 participants

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Diagnostic

Interventions and Outcome Measures

Interventions

Muscle Pattern Recognition (MPR)

Primary outcome measure

  • 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 [ Time Frame: undefined ]

Central Contacts and Locations

Central contacts

Suzan D Olson, PhD, MHS, RN

269.329.3517solson@midwestcct.com

Leslie Johnson

269.329.3517ljohnson@midwestcct.com

Locations

Midwest Consultants for Clinical Trials LLC

Recruiting

Portage, Michigan, United States, 49002

Contacts

Suzan Olson, PhD

269-329-3517solson@midwestcct.com

Gail Massey, RN

269-329-3517gmassey@midwestcct.com

Principal Investigator:

Mark Noffsinger, MD

More Information

Sponsor

iTech Medical, Inc.

Last update posted

Oct 26, 2005

Last verified

Aug, 2005

Keywords

  • Musculoskeletal abnormality
  • Musculoskeletal physiology
  • Musculoskeletal disease
  • Musculoskeletal dysfunction

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by iTech Medical, Inc. on 2005-10-26.