Evidence for Central Sensitization in Patients With Chronic Whiplash Associated Disorders Based on Self-reported Outcomes of Pain (Beliefs), Disability, Central Sensitization, Quantitative Sensory Testing, and Electro-encephalography.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Self-reported functional status or disability
研究概览
简要总结
This is a cross-sectional case-control study in which 70 patients with chronic whiplash associated disorders will be recruited and compared to 70 healthy pain-free controls. The primary research question is to determine differences is self-reported functional status, pain, health-related quality of life, psychological correlates, measures of central sensitization, quantitative sensory testing (QST) and quantitative scalp Electroencephalography (EEG) to measure various parameters of brain activation. The secondary research question is to determine whether relationships can be found between the self-reported outcomes on one hand and the QST and EEG on the other hand.
详细描述
Chronic whiplash associated disorders (CWAD) are frequently occuring conditions with varying degrees of neck pain and disability. They occur usually as a consequence of a motor vehicle accident. Acute whiplash injury has an annual incidence of 200-300 per 100.000 and affects 83% of persons in a traffic collision. Up to 50% of WAD patients do not fully recover, and up to 25% continue to have moderate to severe pain-related disabilities. The consequent pain and disability give rise to substantial socioeconomic cost. In Europe, the annual cost of WAD was estimated to be 12 billion euro.
Chronic neck pain, as observed in CWAD, is often incompletely responsive to available therapies. Due to the current lack of knowledge concerning the underlying factors responsible for the maintenance of these chronic pain conditions, there is no consensus on dedicated and specific therapy approaches for CWAD, resulting in a treatment gap in this condition. The chronicity and severeness of the disorders has led to paradigm shifts in the reasoning about chronic pain from seeing it as a symptom towards as a disease. Neuroimaging has provided evidence that chronic pain is a multidimensional process affecting sensory and emotional processing based on an altered state of the central nervous system in the form of central sensitization (CS). This sensitization results from an increased responsiveness to a variety of stimuli and expresses itself in the form of hyperalgesia, allodynia, referred pain, and ultimately in chronic widespread pain. Changes in both structural and functional brain activity and connectivity over time contribute to an augmentation of pain perception, by an enhanced pain facilitation and defective inhibition of nociceptive signals. It remains however debated whether CS is present as a pathophysiological feature in CWAD.
In this project we hypothesize that CS is one of the main features of the pathophysiology of CWAD, and that relationships occur between QST and EEG on one hand, and self-reported pain, disability, quality of life, psychological correlates and central sensitization on the other hand.
Therefore, 70 patients with CWAD and 70 (gender and age) matched healthy controls will be invited to fill out questionnaires, perform a QST protocol and EEG measurements.
The questionnaires will be filled out online during the two weeks before the determined testing moment and will consist of the Neck Disability Index, the Short Form Health Survey-36 items, a 0-10 Numeric Rating Scale for pain, the Central Sensitization Inventory, the Dutch version of the Pain Catastrophizing Scale, the Impact of Event Scale revised, the Pain anxiety symptoms scale (PASS-20), the patient specific complaints questionnaire (PSK), the Dolour neuropathic 4 (DN4) and the Leeds Assessment of Neuropathic Symptoms and Signs pain scale (S-LANSS). Dutch versions of all questionnaires will be used.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
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
- 未提供
排除标准
- 未提供
结局指标
主要结局
Self-reported functional status or disability
时间窗: Single assessment, within 2 weeks before test moment
The Dutch version of the Neck Disability Index (questionnaire)
Self-reported health-related quality of life
时间窗: Single assessment, within 2 weeks before test moment
The Dutch version of the Short Form Health Survey-36 items (questionnaire)
Self-reported pain assessment
时间窗: Single assessment, at test moment
A 0-10 Numeric Rating Scale for pain (questionnaire). Patients fill out the Numeric Rating Scale (0 no pain - 10 worst pain imaginable) for their perceived neck pain.
Electrical detection and electrical pain thresholds with a constant current electrical stimulator (DS7A Digitimer)
时间窗: Single assessment, during single test moment (duration: approximately 20min), date of test moment will be determined based on the availability of the subject.
Determination of the electrical detection and electrical pain threshold with the electrical stimulator will be performed at the sural nerve of the dominant leg and at the median nerve of the arms.
Self-reported central sensitization symptoms
时间窗: Single assessment, within 2 weeks before test moment
The Dutch version of the Central Sensitization Inventory (questionnaire)
Endogenous pain facilitation assessed by a temporal summation paradigm
时间窗: Single assessment, during single test moment (duration: approximately 10min), date of test moment will be determined based on the availability of the subject.
Temporal summation of electrical pain will be assessed by delivering 20 electrical stimuli at the intensity of the electrical pain threshold.
Endogenous pain inhibition assessed by a conditioned pain modulation paradigm
时间窗: Single assessment,during single test moment (duration: approximately 10min), date of test moment will be determined based on the availability of the subject.
Conditioned pain modulation will be tested with electrical stimulation as test stimulus and the cold pressor test (immersion the hand up to the wrist in cold water of 12°C) as conditioning stimulus.
Resting state brain activity
时间窗: Single assessment, during single test moment (duration: approximately 5min), date of test moment will be determined based on the availability of the subject.
Quantitative Electroencephalography (QEEG) will be recorded from 32 Sn surface electrodes using an electrode cap during 5 minutes of sitting on a chair with eyes closed. Spectral power will be analyzed.
Event-related potentials
时间窗: Single assessment, during single test moment (duration: approximately 20min), date of test moment will be determined based on the availability of the subject.
Quantitative Electroencephalography (QEEG) will be recorded from 32 Sn surface electrodes using an electrode cap during the conditioned pain modulation paradigm. Latency and amplitude of the event-related potentials will be calculated.
次要结局
未报告次要终点
