Chronic Spinal Pain Clinical Trial
Official title:
A Modern Neuroscience Approach to Chronic Spinal Pain: Pain Neuroscience Education Combined With Cognition-targeted Motor Control Training
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.
n/a
Status | Clinical Trial | Phase | |
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Recruiting |
NCT05840354 -
rTMS and Steroid Joint Steroid Injection in Chronic Spinal Pain
|
N/A |