Ignite Creation Date:
2024-05-05 @ 11:48 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00134225
Status:
UNKNOWN
Last Update Posted:
2005-10-26
First Post:
2005-08-22
Brief Title:
Study to Demonstrate That Muscle Pattern Recognition MPR is an Effective Evaluation Tool for Musculoskeletal Neck or Back Pain
Sponsor:
iTech Medical Inc
Organization:
iTech Medical Inc
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2005-08
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 clinicians 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
Muscle pattern recognition MPR testing will show statistically different results between these groups This statistically significant finding in MPR results will enhance a clinicians 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
Detailed Description:
Investigators aim to use data from both the able-bodied and non able-bodied samples to create a normative database for this technology The primary objective of populating a normative database will be to construct a reliable and valid normative database representative of the North American population for use with a discriminative analysis tool which will differentiate abnormal musculoskeletal function from normal musculoskeletal function
Study Population The study population will be composed of 480 asymptomatic participants able-bodied individuals and symptomatic non able-bodied individuals individuals with musculoskeletal non-surgical injuries of the neck and back selected first on the basis of a screening questionnaire
Upon signing an informed consent to participate in the study participants will complete screening questionnaires They will be independently evaluated by two clinicians well experienced in the field of musculoskeletal medicine who obtain a detailed medical history with particular attention to the strict inclusionexclusion criteria and perform a standardized physical examination This standardized clinical examination consists of the most current Gold Standard
Most patients presenting with musculoskeletal complaints of the back or neck and are frequently given this diagnosis solely on the basis of the first line healthcare providers history and physical examinations
To ensure the statistical strength of the history and physical selection process for further inclusion into the study participants will undergo two separate clinical examinations Each will be performed independently by physicians who are specialists in two different fields of practice that commonly see neck and back pain patients and who must agree if a subject is clinically normal or not
If selected for continued participation each participant will undergo Magnetic Resonance Imaging MRI of the spine sagittal views of the entire spine plain X-rays of the entire spine AP and Lateral views blood studies CBC Sedimentation Rate CPK Calcium Phosphorous Pregnancy test drug screen and MPR testing
A total of 480 clinically and lab normal able-bodiednot-able bodied individuals will be selected and examined over a period of twelve months at 4 different centers
Able-Bodied Participants
A total of approximately 240 able-bodied participants will be divided by gender male female and by age classes specifically 18-30 years 31-45 years and 46-62 years This sample size was selected in part because Edgerton et al reported that recruitment patterns of the neck or back differ dependent upon gender and our goal is to have a population of approximately 120 males and 120 females
At the close of the study investigators will segment the population into the three age groups mentioned the proposed sample sizes are thought to be appropriate for statistical analysis while still capturing a variety of subject types The overall age range was chosen to represent the main working population in North America but to not exceed an upper age range where muscle recruitment patterns may vary on a natural evolutionary basis
The total number of normalable-bodied participants will be collected from 4 independent research centers in the US and Canada with an expected maximum of approximately 60 individuals per center A sub-group of 32 randomly assigned able-bodied volunteers will be scheduled for a second MPR test approximately 7 days after their initial testing to examine the reliability of the MPR evaluation tool In the selection process every effort will be made to avoid bias toward a non-working population ie testing only in the morning or afternoon and to obtain representative proportions of the age and race classes existing in North America
Not Able-Bodied Participants
Investigators aim to construct a valid and reliable profile of clinically not normal individuals diagnosed as suffering from musculoskeletal neck or back pain that will be used to confirm our hypothesis and the ability of the MPR evaluation to provide valid reliable and objective information for the clinician
These 240 not able-bodied volunteers will be selected using the same inclusionexclusion criteria and standardized medical histories and physical examinations as above One exception to the exclusion criteria is that if a not-normal participant uses ongoing medications for control of discomfort it will be left to the discretion of each investigator as to how that individuals medication profile may affect their pain reporting physical performance or compliance with the protocol steps A 3-day medication wash-out will be allowed and encouraged if there is any concern about a participants performance
In order to conduct an appropriate discriminate analysis half of the recruited participants will be an able-bodied sample of participants Half of the participants will fall into the not able-bodied participant sample Every effort will be made in the selection process to avoid bias toward a non-working population ie testing only in the morning or afternoon and obtain representative proportions of the age and race classes existing in North America
During the data collection process other clinical categories could be defined for additional statistical analysis such as the loci of symptoms ie lumbar thoracic cervical the level of symptoms lower mid or upper back and the laterality of symptoms left or right Upon analysis of the laboratory and image findings MRI X-ray blood tests other anatomic findings or variations such as degenerative disc disease size of possible disc protrusions Sedimentation Rate or CPK values Schmorlds nodes etc may also be discussed
Not able-bodied volunteers may have long standing back or neck pain or pain symptoms as recently as several days after a date of injury This more immediate window of pain will be allowed to include acute events but not until or unless the individual is able to perform the nine movements necessary for the MPR testing procedure The outer time duration of pain was chosen to include individuals with more chronic complaints but not if other compensatory or secondary gain issues appear present such as may occur with Workers Compensation claims disability claims or litigation It is the desire of investigators to include appropriate acute sub-acute and chronic neck or back pain sufferers
We believe that the design of this study will prove that the evaluation provided by the MPR testing modality should be the tool of choice for the objective evaluation and case management of patients presenting with musculoskeletal non-surgical neck and back pain as it will differentiate normal asymptomatic able-bodied individuals from those individuals not normal with underlying biomechanical dysfunctions
Study Population The study population will be composed of 480 asymptomatic participants able-bodied individuals and symptomatic non able-bodied individuals individuals with musculoskeletal non-surgical injuries of the neck and back selected first on the basis of a screening questionnaire
Upon signing an informed consent to participate in the study participants will complete screening questionnaires They will be independently evaluated by two clinicians well experienced in the field of musculoskeletal medicine who obtain a detailed medical history with particular attention to the strict inclusionexclusion criteria and perform a standardized physical examination This standardized clinical examination consists of the most current Gold Standard
Most patients presenting with musculoskeletal complaints of the back or neck and are frequently given this diagnosis solely on the basis of the first line healthcare providers history and physical examinations
To ensure the statistical strength of the history and physical selection process for further inclusion into the study participants will undergo two separate clinical examinations Each will be performed independently by physicians who are specialists in two different fields of practice that commonly see neck and back pain patients and who must agree if a subject is clinically normal or not
If selected for continued participation each participant will undergo Magnetic Resonance Imaging MRI of the spine sagittal views of the entire spine plain X-rays of the entire spine AP and Lateral views blood studies CBC Sedimentation Rate CPK Calcium Phosphorous Pregnancy test drug screen and MPR testing
A total of 480 clinically and lab normal able-bodiednot-able bodied individuals will be selected and examined over a period of twelve months at 4 different centers
Able-Bodied Participants
A total of approximately 240 able-bodied participants will be divided by gender male female and by age classes specifically 18-30 years 31-45 years and 46-62 years This sample size was selected in part because Edgerton et al reported that recruitment patterns of the neck or back differ dependent upon gender and our goal is to have a population of approximately 120 males and 120 females
At the close of the study investigators will segment the population into the three age groups mentioned the proposed sample sizes are thought to be appropriate for statistical analysis while still capturing a variety of subject types The overall age range was chosen to represent the main working population in North America but to not exceed an upper age range where muscle recruitment patterns may vary on a natural evolutionary basis
The total number of normalable-bodied participants will be collected from 4 independent research centers in the US and Canada with an expected maximum of approximately 60 individuals per center A sub-group of 32 randomly assigned able-bodied volunteers will be scheduled for a second MPR test approximately 7 days after their initial testing to examine the reliability of the MPR evaluation tool In the selection process every effort will be made to avoid bias toward a non-working population ie testing only in the morning or afternoon and to obtain representative proportions of the age and race classes existing in North America
Not Able-Bodied Participants
Investigators aim to construct a valid and reliable profile of clinically not normal individuals diagnosed as suffering from musculoskeletal neck or back pain that will be used to confirm our hypothesis and the ability of the MPR evaluation to provide valid reliable and objective information for the clinician
These 240 not able-bodied volunteers will be selected using the same inclusionexclusion criteria and standardized medical histories and physical examinations as above One exception to the exclusion criteria is that if a not-normal participant uses ongoing medications for control of discomfort it will be left to the discretion of each investigator as to how that individuals medication profile may affect their pain reporting physical performance or compliance with the protocol steps A 3-day medication wash-out will be allowed and encouraged if there is any concern about a participants performance
In order to conduct an appropriate discriminate analysis half of the recruited participants will be an able-bodied sample of participants Half of the participants will fall into the not able-bodied participant sample Every effort will be made in the selection process to avoid bias toward a non-working population ie testing only in the morning or afternoon and obtain representative proportions of the age and race classes existing in North America
During the data collection process other clinical categories could be defined for additional statistical analysis such as the loci of symptoms ie lumbar thoracic cervical the level of symptoms lower mid or upper back and the laterality of symptoms left or right Upon analysis of the laboratory and image findings MRI X-ray blood tests other anatomic findings or variations such as degenerative disc disease size of possible disc protrusions Sedimentation Rate or CPK values Schmorlds nodes etc may also be discussed
Not able-bodied volunteers may have long standing back or neck pain or pain symptoms as recently as several days after a date of injury This more immediate window of pain will be allowed to include acute events but not until or unless the individual is able to perform the nine movements necessary for the MPR testing procedure The outer time duration of pain was chosen to include individuals with more chronic complaints but not if other compensatory or secondary gain issues appear present such as may occur with Workers Compensation claims disability claims or litigation It is the desire of investigators to include appropriate acute sub-acute and chronic neck or back pain sufferers
We believe that the design of this study will prove that the evaluation provided by the MPR testing modality should be the tool of choice for the objective evaluation and case management of patients presenting with musculoskeletal non-surgical neck and back pain as it will differentiate normal asymptomatic able-bodied individuals from those individuals not normal with underlying biomechanical dysfunctions
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None