Does Peripheral Neuroinflammation Predict Chronicity Following Whiplash?
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 147
- 试验地点
- 2
- 主要终点
- Fractional anisotropy from diffusion tensor images
研究概览
简要总结
Whiplash describes an injury to the neck caused by a rapid movement of the head. It often occurs during a motor vehicle collision, causing considerable pain and distress. Most patients are diagnosed with whiplash associated disorder grade-2 (WAD2). Half of these patients develop chronic pain. Current treatments for patients are ineffective. It is difficult to predict which patients will develop chronic pain, and therefore how to manage these patients. The characteristics of pain felt by many patients with WAD2 suggests that symptoms are caused by an injury to the nerves in the neck and arm. However, on clinical examination there is no indication that these nerves are significantly injured.
Work from the investigators' laboratory suggests that nerves may be inflamed. In this study, the contribution of nerve inflammation to symptoms early following whiplash will be established. It will determine whether clinical tests are able to identify those patients with inflamed nerves. It will also determine whether the presence of nerve inflammation can be used to identify patients who develop chronic pain. The study will recruit 115 patients within one month following a whiplash injury and thirty-two healthy volunteers. Participants will undergo a clinical assessment. A blood sample will be taken to look for inflammatory proteins and magnetic resonance imaging will be used to identify nerve inflammation in the neck and wrist. Questionnaires to establish neck disability, pain quality and psychological distress will be completed. MRI findings will be compared to healthy controls. At six-months, patients will be asked to repeat the questionnaires, which will be used to identify those patients who have recovered. Twenty-five recovered and twenty-five non-recovered patients will undergo a repeat MRI and clinical assessment. Although patients on this study will not directly benefit, the findings will help with early diagnosis and could refocus treatment to reduce chronic pain.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female patients with chronic whiplash associated disorder that meet the Quebec Task Force Classification of whiplash grade II
- •Within approximately four weeks of their whiplash injury
- •Participants capable of giving informed consent
- •Healthy Volunteers:
- •Free of neck or upper limb pain
- •No history of a whiplash injury or of neck or arm pain lasting >3 months or any recent cervical or upper limb trauma requiring medical treatment.
- •Participants capable of giving informed consent
排除标准
- •Diagnosis of whiplash grade I (neck complaints without physical signs), III (obvious neurological signs) or IV (fracture or dislocation)
- •Experienced concussion or loss of consciousness as a result of the accident
- •Previous history of whiplash
- •Previous history of neck pain or headaches that required treatment
- •All participants (patients and healthy volunteers):
- •Unsuitability to undergo MRI (assessed with the MRI screening questionnaire)
- •History of inflammatory disease (e.g. autoimmune diseases, rheumatoid arthritis), neuropathy, diabetes, cancer or non-medically controlled hypertension
- •Current ongoing steroid treatment
- •Participants with an inadequate understanding of English will also be excluded
结局指标
主要结局
Fractional anisotropy from diffusion tensor images
时间窗: Baseline
Fractional anisotropy measurements from brachial plexus and median nerve compared to healthy controls
Change in fractional anisotropy from Diffusion tensor images
时间窗: From baseline to 6 months
Fractional anisotropy from brachial plexus and median nerve compared to baseline
MRI T2-weighted nerve signal strength
时间窗: Baseline
T2-weighted nerve signal strength in the brachial plexus and median nerve compared to healthy control group
Change in MRI T2-weighted nerve signal strength
时间窗: From baseline to 6 months
Change in T2-weighted nerve signal strength in the brachial plexus and median nerve at 6 months compared to baseline
次要结局
- Pro-inflammatory cytokine levels(Baseline)
- Tests for heightened nerve mechanosensitivity- Pressure pain threshold(Baseline)
- Change to Quantitative sensory testing- warm and cold pain thresholds(From baseline to 6 months)
- Change in Short post-traumatic stress inventory(From baseline to 6 months)
- Change in Pro-inflammatory cytokine levels(From baseline to 6 months)
- Change in heightened nerve mechanosensitivity- Pressure pain threshold(From baseline to 6 months)
- Quantitative sensory testing- warm and cold pain thresholds(Baseline)
- Change in Quantitative sensory testing- Mechanical pain threshold(From baseline to 6 months)
- Quantitative sensory testing- Pressure pain threshold(Baseline)
- Change in quantitative sensory testing- Pressure pain threshold(From baseline to 6 months)
- Changes to T1 MRI median nerve morphology(From baseline to 6 months)
- Change in painDETECT questionnaire(From baseline to 6 months)
- T1 MRI median nerve morphology(Baseline)
- Tests for heightened nerve mechanosensitivity- upper limb neurodynamic test (median nerve)(Baseline)
- Quantitative sensory testing- Mechanical pain threshold(Baseline)
- Change to tests for heightened nerve mechanosensitivity- upper limb neurodynamic test (median nerve)(From baseline to 6 months)
- Changes in Pain levels on Visual analogue scale(From baseline to 6 months)
- Change in Neck disability index(From baseline to 6 months)