Clinical trial NCT02098005: Pain Neuroscience Education Combined With Cognition-targeted Motor Control Training
Official title: A Modern Neuroscience Approach to Chronic Spinal Pain: Pain Neuroscience Education Combined With Cognition-targeted Motor Control Training
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Chronic Spinal Pain
Lead sponsor: University Ghent
Sponsor class: OTHER
Collaborators: name: Agentschap voor Innovatie door Wetenschap en Technologie
name: Vrije Universiteit Brussel
name: University Hospital, Ghent
First posted: 2014-03-27
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Pain assessment (questionnaire)
timeFrame: at baseline
measure: Pain assessment (physical testing)
timeFrame: at baseline
measure: Functional assessment (questionnaires)
timeFrame: at baseline
measure: Pain assessment (questionnaire)
timeFrame: at 3 months
measure: Pain assessment (questionnaire)
timeFrame: at 6 months
measure: Pain assessment (questionnaire)
timeFrame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)
measure: Pain assessment (physical testing)
timeFrame: at 3 months
measure: Pain assessment (physical testing)
timeFrame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)
measure: Functional assessment (questionnaires)
timeFrame: at 1 week
measure: Functional assessment (questionnaires)
timeFrame: at 3 months
measure: Functional assessment (questionnaires)
timeFrame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)
measure: Functional assessment (questionnaires)
timeFrame: at 6 months
Secondary outcomes:
measure: Gray and white matter structure
timeFrame: at baseline
measure: Motor Control
timeFrame: at baseline
measure: Psychological correlates
timeFrame: at baseline
measure: Neurophysiology of pain test (questionnaire)
timeFrame: at 1 week
measure: Psychological correlates
timeFrame: at 1 week
measure: Psychological correlates
timeFrame: at 3 months
measure: Psychological correlates
timeFrame: at 6 months
measure: Psychological correlates
timeFrame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)
measure: Muscle properties
timeFrame: at baseline
measure: Muscle properties
timeFrame: at 3 months
measure: Muscle properties
timeFrame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)
measure: Motor Control
timeFrame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)
measure: Motor Control
timeFrame: at 3 months
measure: Gray and white matter structure
timeFrame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)
measure: Gray and white matter function
timeFrame: at 3 months
measure: Gray and white matter structure
timeFrame: at 3 months
measure: Gray and white matter function
timeFrame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)
measure: Gray and white matter function
timeFrame: at baseline
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: Ghent University Hospital
city: Ghent
country: Belgium
facility: Universiteit Gent (UGent), Faculty of Medicine and Health Sciences, Dpt. Of Rehabilitation Sciences and Physiotherapy, BE-9000 Gent (Belgium)
city: Jette
country: Belgium
facility: Vrije Universiteit Brussel, Faculty of Physical Education & Physiotherapy, Dpt. of Rehabilitation Sciences & Physiotherapy
Study officials:
affiliation: University Ghent
name: Lieven Danneels, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Vrije Universiteit Brussel
name: Jo Nijs, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Van Bogaert W, Coppieters I, Kregel J, Nijs J, De Pauw R, Meeus M, Cagnie B, Danneels L, Malfliet A. Influence of Baseline Kinesiophobia Levels on Treatment Outcome in People With Chronic Spinal Pain. Phys Ther. 2021 Jun 1;101(6):pzab076. doi: 10.1093/ptj/pzab076.
citation: Willaert W, Malfliet A, Coppieters I, Lenoir D, De Pauw R, Danneels L, Roussel N, Meeus M, Cagnie B, Nijs J, Kregel J. Does Pain Neuroscience Education and Cognition-Targeted Motor Control Training Improve Cervical Motor Output? Secondary Analysis of a Randomized Clinical Trial. Pain Pract. 2020 Jul;20(6):600-614. doi: 10.1111/papr.12884. Epub 2020 Apr 20.
citation: Lenoir D, Coppieters I, Willaert W, Kregel J, Danneels L, Cagnie B, Meeus M, Nijs J, Malfliet A. Do sociodemographic features, pain sensitivity or pain catastrophizing relate to clinic-based adherence to physiotherapy in people suffering from chronic spinal pain? Secondary analysis of a randomized clinical trial. Musculoskelet Sci Pract. 2019 Dec;44:102066. doi: 10.1016/j.msksp.2019.102066. Epub 2019 Sep 26.
citation: Malfliet A, Kregel J, Coppieters I, De Pauw R, Meeus M, Roussel N, Cagnie B, Danneels L, Nijs J. Effect of Pain Neuroscience Education Combined With Cognition-Targeted Motor Control Training on Chronic Spinal Pain: A Randomized Clinical Trial. JAMA Neurol. 2018 Jul 1;75(7):808-817. doi: 10.1001/jamaneurol.2018.0492.
citation: Malfliet A, Kregel J, Meeus M, Roussel N, Danneels L, Cagnie B, Dolphens M, Nijs J. Blended-Learning Pain Neuroscience Education for People With Chronic Spinal Pain: Randomized Controlled Multicenter Trial. Phys Ther. 2018 May 1;98(5):357-368. doi: 10.1093/ptj/pzx092.
citation: Dolphens M, Nijs J, Cagnie B, Meeus M, Roussel N, Kregel J, Malfliet A, Vanderstraeten G, Danneels L. Efficacy of a modern neuroscience approach versus usual care evidence-based physiotherapy on pain, disability and brain characteristics in chronic spinal pain patients: protocol of a randomized clinical trial. BMC Musculoskelet Disord. 2014 May 8;15:149. doi: 10.1186/1471-2474-15-149.