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
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 480
- 试验地点
- 4
- 主要终点
- 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
研究概览
简要总结
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.
详细描述
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 inclusion/exclusion 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Single
入排标准
- 年龄范围
- 18 Years 至 62 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
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
次要结局
未报告次要终点