Shifting Away From Pain: Neurocognitive Approach to Explain and Predict the Response to the Modern Neuroscience Approach for Treating Patients With Whiplash Associated Disorders
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 95
- 试验地点
- 1
- 主要终点
- blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state
研究概览
简要总结
The broad aim of this study is to investigate the effect of a modern neuroscience approach, which combines education on pain neuroscience with cognition-targeted exercise therapy and stress management, on brain structure and networks in patients with chronic whiplash-associated disorders (CWAD) in comparison to a control physiotherapy treatment.
详细描述
This project runs in parallel to a larger randomized-controlled trial (RCT) in which the 'modern neuroscience approach to WAD' is compared to usual care evidence-based physiotherapy (clinical trial registration number: NCT03239938). For the current study, additional magnetic resonance imaging (MRI) measures will be taken in a subsample of patients, who will be recruited from this larger RCT. In addition, a pain-free age- and sex-matched control group will be recruited for comparison.
The current study consists of 2 MRI measurements that will take place at the University Hospital of Ghent (UZ Gent): baseline (pre-treatment) and follow-up (post-treatment; approximately 16 weeks after baseline). After pre-treatment assessment, the patients will be randomly allocated to the modern neuroscience approach or usual care physiotherapy, as part of the RCT.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
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
- 是
入选标准
- •CWAD group:
- •Inclusion Criteria:
- •Experienced a whiplash trauma which is at least 3 months old and causes pain since at least 3 months, with pain experience with a mean pain frequency of 3 or more days per week, and with self-reported moderate to severe pain-related disability, established by a score of 15 or more of a maximum of 50 on the Neck Disability Index
- •Patients classified as WAD II or WAD III on the modified Quebec Task Force Scale
- •Native Dutch speaker
- •Not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain a steady state)
- •Refraining from consuming caffeine, alcohol and nicotine in the hour before the MRI scans (in both measurement times: before the start of the rehabilitation and after the end of the rehabilitation).
排除标准
- •Neuropathic pain
- •Being pregnant or having given birth in the preceding year
- •Chronic fatigue syndrome
- •Fibromyalgia
- •Cardiovascular disorders
- •Endocrinological disorders
- •Rheumatic disorders
- •Psychiatric disorders
- •History of neck surgery
- •Loss of consciousness during/after the whiplash trauma
- •MRI incompatible health condition (e.g., pacemaker, metal prosthetic devices)
- •Psychiatric condition and ongoing medication that would alter emotional or sensory processing
- •Claustrophobia.
- •Healthy volunteers: (matched for age and gender). Additional exclusion criteria include for healthy volunteers
- •a history of a chronic pain syndrome
- •a pain condition in the last six months for which treatment was sought
研究组 & 干预措施
Modern pain neuroscience approach
Behavioral: Modern pain neuroscience approach
干预措施: Modern pain neuroscience approach (Behavioral)
Usual care evidence-based physiotherapy
Behavioral: Usual care evidence-based physiotherapy
干预措施: Usual care physiotherapy (Behavioral)
结局指标
主要结局
blood oxygenation level dependent (BOLD) signal (functional MRI) during picture imagination task and during resting state
时间窗: Baseline (pre-treatment) assessment and follow-up assessment after 16 weeks of therapy (end of treatment).
change between baseline assessment and the follow-up assessment after 16 weeks (after end of treatment) will be examined
structural MRI measures (i.e., grey and white matter)
时间窗: Baseline (pre-treatment) assessment and follow-up assessment after 16 weeks of therapy (end of treatment).
change between baseline assessment and the follow-up assessment after 16 weeks (after end of treatment) will be examined
次要结局
未报告次要终点