Pain Neuroscience Education Combined With Cognition-targeted Motor Control Training

Study Overview
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Brief Summary
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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.

Official Title
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A Modern Neuroscience Approach to Chronic Spinal Pain: Pain Neuroscience Education Combined With Cognition-targeted Motor Control Training

Conditions
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Chronic Spinal Pain

Intervention / Treatment
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* Other: usual care evidence-based physiotherapy
* Other: modern neuroscience approach


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Usual care<br>usual care evidence-based physiotherapy | Other: usual care evidence-based physiotherapy<br>* Arm 1 (i.e., the control group) will be subjected to a control intervention, including back/neck school and general exercises. 3 sessions of education (session 1: group session; session 2: online module; session 3: individual session) will be given by a physiotherapist, followed by 15 sessions of traditional physiotherapy and general exercises. The 18 sessions will be spread over a period of 3 months.<br>|
| Experimental: modern neuroscience approach<br>modern neuroscience approach | Other: modern neuroscience approach<br>* Arm 2 (i.e., the experimental group) will receive pain neuroscience education (3 sessions of education), followed by 15 sessions of cognition-targeted motor control training (15 sessions). The 18 sessions will be spread over a period of 3 months.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain assessment (questionnaire) | questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36) | at baseline | 
| Pain assessment (physical testing) | Physical testing: pressure pain threshold (PTT), cold pressor test (CPT) | at baseline | 
| Functional assessment (questionnaires) | Questionnaires: PDI, SF-36 | at baseline | 
| Pain assessment (questionnaire) | questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36) Time Frame: after 18 treatment sessions | at 3 months | 
| Pain assessment (questionnaire) | questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36) | at 6 months | 
| Pain assessment (questionnaire) | questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36) | at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) | 
| Pain assessment (physical testing) | Physical testing: pressure pain threshold (PTT), cold pressor test (CPT) Time Frame: after 18 treatment sessions | at 3 months | 
| Pain assessment (physical testing) | Physical testing: pressure pain threshold (PTT), cold pressor test (CPT) | at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) | 
| Functional assessment (questionnaires) | Questionnaires: PDI, SF-36 Timeframe: after 3 treatment sessions (PDI) | at 1 week | 
| Functional assessment (questionnaires) | Questionnaires: PDI, SF-36 Time Frame: after 18 treatment sessions | at 3 months | 
| Functional assessment (questionnaires) | Questionnaires: PDI, SF-36 | at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) | 
| Functional assessment (questionnaires) | Questionnaires: PDI, SF-36 | at 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Gray and white matter structure | Gray and white matter structure and function in brain areas involved in pain processing and sensorimotor control. Gray matter density - gray matter volumes - cortical thickness - surface area. Integrity of the white matter circuitry (tractography) - structural white matter connectivity - fractional anisotropy Intrinsic brain activity (cortex and nuclei) - functional connectivity | at baseline | 
| Motor Control | Postural steadiness Habitual standing posture Spinal range of motion Sensorimotor control i. Proprioception: position-reposition accuracy ii. Neuromuscular control (patients' ability to perform the skill of activation of specific, deep stabilizing muscles iii. Movement control of the spine | at baseline | 
| Psychological correlates | Psychological correlates: PCS, PVAQ, TSK, IPQ-R | at baseline | 
| Neurophysiology of pain test (questionnaire) | Time Frame: after 3 treatment sessions Questionnaire: Dutch Neurophysiology of Pain Test (patient version) | at 1 week | 
| Psychological correlates | Psychological correlates: PCS, PVAQ, TSK, IPQ-R Time Frame: after 3 treatment sessions | at 1 week | 
| Psychological correlates | Psychological correlates: PCS, PVAQ, TSK, IPQ-R Time Frame: after 18 treatment sessions | at 3 months | 
| Psychological correlates | Psychological correlates: PCS, PVAQ, TSK, IPQ-R | at 6 months | 
| Psychological correlates | Psychological correlates: PCS, PVAQ, TSK, IPQ-R | at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) | 
| Muscle properties | Isometric muscle strength of spinal flexor and extensor muscles Endurance of spinal flexor and extensor muscles | at baseline | 
| Muscle properties | Isometric muscle strength of spinal flexor and extensor muscles Endurance of spinal flexor and extensor muscles Time Frame: after 18 treatment sessions | at 3 months | 
| Muscle properties | Isometric muscle strength of spinal flexor and extensor muscles Endurance of spinal flexor and extensor muscles | at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) | 
| Motor Control | Postural steadiness Habitual standing posture Spinal range of motion Sensorimotor control i. Proprioception: position-reposition accuracy ii. Neuromuscular control (patients' ability to perform the skill of activation of specific, deep stabilizing muscles iii. Movement control of the spine | at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) | 
| Motor Control | Postural steadiness Habitual standing posture Spinal range of motion Sensorimotor control i. Proprioception: position-reposition accuracy ii. Neuromuscular control (patients' ability to perform the skill of activation of specific, deep stabilizing muscles iii. Movement control of the spine Time Frame: after 18 treatment sessions | at 3 months | 
| Gray and white matter structure | Gray and white matter structure and function in brain areas involved in pain processing and sensorimotor control. Gray matter density - gray matter volumes - cortical thickness - surface area. Integrity of the white matter circuitry (tractography) - structural white matter connectivity - fractional anisotropy Intrinsic brain activity (cortex and nuclei) - functional connectivity | at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) | 
| Gray and white matter function | Gray and white matter structure and function in brain areas involved in pain processing and sensorimotor control. Gray matter density - gray matter volumes - cortical thickness - surface area. Integrity of the white matter circuitry (tractography) - structural white matter connectivity - fractional anisotropy Intrinsic brain activity (cortex and nuclei) - functional connectivity Time Frame: after 18 treatment sessions | at 3 months | 
| Gray and white matter structure | Gray and white matter structure and function in brain areas involved in pain processing and sensorimotor control. Gray matter density - gray matter volumes - cortical thickness - surface area. Integrity of the white matter circuitry (tractography) - structural white matter connectivity - fractional anisotropy Intrinsic brain activity (cortex and nuclei) - functional connectivity Time Frame: after 18 treatment sessions | at 3 months | 
| Gray and white matter function | Gray and white matter structure and function in brain areas involved in pain processing and sensorimotor control. Gray matter density - gray matter volumes - cortical thickness - surface area. Integrity of the white matter circuitry (tractography) - structural white matter connectivity - fractional anisotropy Intrinsic brain activity (cortex and nuclei) - functional connectivity | at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) | 
| Gray and white matter function | Gray and white matter structure and function in brain areas involved in pain processing and sensorimotor control. Gray matter density - gray matter volumes - cortical thickness - surface area. Integrity of the white matter circuitry (tractography) - structural white matter connectivity - fractional anisotropy Intrinsic brain activity (cortex and nuclei) - functional connectivity | at baseline |