A Modern Neuroscience Approach to Chronic Spinal Pain: Pain Neuroscience Education Combined With Cognition-targeted Motor Control Training
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 120
- 试验地点
- 6
- 主要终点
- Functional assessment (questionnaires)
研究概览
简要总结
Chronic spinal pain (CSP) includes chronic low back pain, failed back surgery, chronic whiplash associated disorders, chronic non-traumatic neck pain, etc. The current investigators and others have provided evidence for impaired motor control of spinal muscles in patients with CSP. In addition, there is increasing evidence that central mechanisms, i.e. hyperexcitability of the central nervous system and brain abnormalities (e.g. decreased brain matter density) play a role in CSP. Hence, treatments for CSP should not only address the spinal muscles and joints, but also the brain. Therefore, a modern neuroscience approach, comprising of pain neuroscience education followed by cognition-targeted motor control training, can be applied.
The scientific objective entails examining the effectiveness of the modern neuroscience approach vs. usual care evidence-based physiotherapy for reducing pain and improving functioning in Flemish patients with CSP. A secondary objective entails examining the effectiveness of the modern neuroscience approach vs. usual care evidence-based physiotherapy for altering brain's structure and function (magnetic Resonance Imaging) in Flemish patients with CSP. Therefore, a multi-center triple-blind randomized controlled trial will be conducted.
To comply with this scientific objective, 120 CSP patients will be recruited and subjected to the baseline assessment. The baseline assessment includes the assessment of pain (including symptoms of central sensitization and conditioned pain modulation), the assessment of restrictions in functioning, brain imaging, the evaluation of motor control and muscle properties, spinal mobility, and psychosocial correlates. Baseline analysis will provide descriptive statistics and will lead to calculate correlation between the different outcome measures and predictors of pain and dysfunctioning. In a next step, included patients will be randomized to the experimental or control group. Those in the experimental group will receive neuroscience education combined with cognition-targeted motor control training. Those in the control group will be subjected to a control intervention, including back/neck school and general exercises. After the neuroscience education has been given, the experimental subjects will fill in the neurophysiology of pain test. Several follow-up assessments will take place. Part of the assessment (functionality (PDI questionnaire) and psychosocial correlates (Pain Catastrophizing Scale (PCS), pain vigilance and awareness questionnaire (PVAQ), Tampa Scale for Kinesiophobia (TSK), Illness Perception Questionnaire revised (IPQ-R)) will be re-evaluated after the first 3 sessions. The complete 'baseline' assessment will be repeated in the month following the treatment complement, rounding up the short-term follow-up assessment. Six months after the baseline assessment, pain, functioning and psychological correlates are assessed in an intermediate online assessment. One year after baseline assessment the complete assessment is repeated for the last time, unless the intermediate assessment indicates that treatment effects are no longer present. Both short and long term treatment effects can be studied and predictors for therapy success can be unraveled. Also correlations between changes in different outcome measures can provide relevant and innovative information.
The proof of principal suggests a strong effect reported by large effect sizes for pain and disability compared to usual care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 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
- 否
入选标准
- •Nonspecific spinal pain of at least 3 months' duration, at least 3 days per week
- •Aged between 18 and 65 years
- •Seeking care because of neck pain or low back pain
- •Living or working within a radius of 50 km around the therapy location
- •Not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain a steady state)
- •Nonspecific failed back surgery > 3 years are permitted
- •Not undertaking exercise (> 3 metabolic Equivalents) 3 days before the experiment
- •Refraining from analgesics 48h prior to assessments.
- •Abstaining from caffeine, alcohol or nicotine 24h prior to assessment
排除标准
- •Neuropathic pain
- •Chronic widespread pain
- •Being pregnant or having given birth in the preceding year
- •Contra-indications related to MRI imaging
- •History of specific spinal surgery
结局指标
主要结局
Functional assessment (questionnaires)
时间窗: at 6 months
Questionnaires: PDI, SF-36
Pain assessment (questionnaire)
时间窗: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)
questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36)
Pain assessment (physical testing)
时间窗: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)
Physical testing: pressure pain threshold (PTT), cold pressor test (CPT)
次要结局
- Muscle properties(at 12 months (except when no treatment effects would be found at 6 months: go/no go principle))
- Psychological correlates(at 12 months (except when no treatment effects would be found at 6 months: go/no go principle))
- Neurophysiology of pain test (questionnaire)(at 1 week)
- Motor Control(at 3 months)
- Gray and white matter function(at baseline)
- Gray and white matter structure(at 3 months)