NCT00134225

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.

Trial Health

47
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
480

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Apr 2005

Geographic Reach
2 countries

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2005

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 22, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 24, 2005

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2006

Completed
Last Updated

October 26, 2005

Status Verified

August 1, 2005

First QC Date

August 22, 2005

Last Update Submit

October 25, 2005

Conditions

Neck PainLow Back Pain

Keywords

Musculoskeletal abnormalityMusculoskeletal physiologyMusculoskeletal diseaseMusculoskeletal dysfunction

Outcome Measures

Primary Outcomes (1)

  • 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

Interventions

Muscle Pattern Recognition (MPR)DEVICE

Eligibility Criteria

Age18 Years - 62 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Individuals may participate in this study if they meet the following criteria:
  • years of age; male or female.
  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Department of Neurology - UC Irvine

Irvine, California, 92697-4275, United States

NOT YET RECRUITING

Midwest Consultants for Clinical Trials LLC

Portage, Michigan, 49002, United States

RECRUITING

Advance Clinical Research

Salt Lake City, Utah, 84102, United States

NOT YET RECRUITING

Institute de Rescherche in Physiatrie du Quebec

Montreal, Quebec, H2K 1C1, Canada

NOT YET RECRUITING

Related Publications (4)

  • 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.

    BACKGROUND

  • 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).

    BACKGROUND

  • 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).

    RESULT

  • 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. doi: 10.1097/00005768-199606000-00013.

    PMID: 8784762RESULT

MeSH Terms

Conditions

Neck PainLow Back PainMusculoskeletal AbnormalitiesMusculoskeletal Diseases

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsBack PainCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Alan Goldman, MD

    Impact Medical Solutions, Inc.

    STUDY DIRECTOR

Central Study Contacts

Suzan D Olson, PhD, MHS, RN

CONTACT

269.329.3517solson@midwestcct.com

Leslie Johnson

CONTACT

269.329.3517ljohnson@midwestcct.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
SINGLE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

August 22, 2005

First Posted

August 24, 2005

Study Start

April 1, 2005

Study Completion

December 1, 2006

Last Updated

October 26, 2005

Record last verified: 2005-08

Locations

US(3)CA(1)