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
Recruitment status was Recruiting
Sponsor:
iTech Medical, Inc.
Information provided by:
iTech Medical, Inc.
ClinicalTrials.gov Identifier:
NCT00134225
First received: August 22, 2005
Last updated: October 25, 2005
Last verified: August 2005
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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
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 May 16, 2013