Neuromuscular Mechanisms Underlying Poor Recovery From Whiplash Injuries
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 97
- 试验地点
- 2
- 主要终点
- MRI to assess the changes in markers of altered cervical spinal cord physiology and muscle degeneration.
研究概览
简要总结
This study is investigating whether changes in the shape and size of bodily muscles and spinal cord anatomy can influence recovery rates following a motor vehicle collision (MVC). The objective is to demonstrate that the presence of muscle and spinal cord degeneration and associated muscle weakness is the consequence of a mild MVC-related injury involving the cervical spinal cord.
详细描述
Whiplash is a condition that consists of patients that display varying degrees of pain and disability. Most patients should expect full-recovery within the first 2-3 months post injury. At the other end of the spectrum is a group of patients (~ 25%) who continue to have moderate-severe pain-related disability in the long-term. Reasons for this transition to chronicity are largely unknown. The situation would benefit if there were radiological findings of the disorder. However, clear and consistent findings of injured tissues on standard radiological exams remain elusive.
As part of this study, the investigators will innovatively investigate measures to 1) quantify the temporal development of widespread muscle degeneration, 2) identify quantifiable markers of altered cervical spinal cord physiology, 3) quantify reductions in central activation and fatigue 4) evaluate potential genetic variants that may be associated with chronic pain after a MVC and 5) determine the mediational influence of psychosocial factors on recovery rates following whiplash injury, as a potential mechanism underlying the transition to chronic pain.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Males and Females (18 - 65 years of age)
- •Individuals less than one week post MVA with a primary complaint of neck pain.
- •Able to give written informed consent and complete interviews in English
排除标准
- •Individuals with a spinal fracture from the MVA, or spinal surgeries
- •History of one or more MVAs or previous diagnosis of cervical or lumbar radiculopathy
- •History of neurological disorders (e.g. Multiple Sclerosis, previous stroke, myelopathy), inflammatory diseases (e.g. Hepatitis, Systemic Lupus Erythematosus, Rheumatoid Arthritis or Osteoarthritis, Alzheimers, Ankylosing Spondylitis, Crohn's disease, Fibromyalgia) or metabolic disorders (e.g. Diabetes, hyper- and hypo-thyroidism)
- •Standard contraindications to MRI: claustrophobia, metallic implants, pacemaker and pregnancy.
结局指标
主要结局
MRI to assess the changes in markers of altered cervical spinal cord physiology and muscle degeneration.
时间窗: < 1 week; 2 weeks; 3 months; 1 year of MVC
次要结局
- Pain Management Inventory (PMI) Questionnaire(< 1 week; 2 weeks; 3 months; 1 year of MVC)
- Post-traumatic Diagnostic Scale (PDS) Questionnaire(< 1 week; 2 weeks; 3 months; 1 year of MVC)
- Tampa Questionnaire(< 1 week; 2 weeks, 3 months; 1 year of MVC)
- Center for Epidemiological Studies - Depression Scale Questionnaire(< 1 week; 2 weeks; 3 months; 1 year of MVC)
- Hospital Anxiety and Depression Scale Questionnaire(< 1 week; 2 weeks; 3 months; 1 year of MVC)
- Traumatic Injuries Distress Scale and a Symptom Index(< 1 week; 2 weeks; 3 months; 1 year after MVC)
- Prediction of Post-MVC Chronic Axial Pain Assessment(Baseline visit)
- Follow-Up Data Collection Form for clinical prediction(2 week; 3 month; 1 year of MVC)
- Neck Disability Index (NDI) Questionnaire(<1 week; 2 weeks, 3 months; 1 year of MVC)
- Coping Strategy Questionnaire-C(< 1 week; 2 weeks; 3 months; 1 year of MVC)
- Impact of Events Scale Questionnaire(< 1 week; 2 weeks; 3 months; 1 year of MVC)
- RNA and DNA blood collection(within a week of MVC)
- Strength and reflex testing in the lower leg(2 weeks; 3 months; 1 year)
- Pedometer: wear for 2 consecutive weeks(2 weeks; 3 months after MVC)
研究者
James Elliott
Assistant Professor
Northwestern University