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
| Verified date | May 2017 |
| Source | University Ghent |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 120 |
| Est. completion date | April 2016 |
| Est. primary completion date | April 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
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 |
| Country | Name | City | State |
|---|---|---|---|
| Belgium | Ghent University Hospital | Ghent | |
| Belgium | Universiteit Gent (UGent), Faculty of Medicine and Health Sciences, Dpt. Of Rehabilitation Sciences and Physiotherapy, BE-9000 Gent (Belgium) | Ghent | |
| Belgium | Vrije Universiteit Brussel, Faculty of Physical Education & Physiotherapy, Dpt. of Rehabilitation Sciences & Physiotherapy | Jette |
| Lead Sponsor | Collaborator |
|---|---|
| University Ghent | Agentschap voor Innovatie door Wetenschap en Technologie, University Hospital, Ghent, Vrije Universiteit Brussel |
Belgium,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Pain assessment (questionnaire) | questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36) | at baseline | |
| Primary | Pain assessment (physical testing) | Physical testing: pressure pain threshold (PTT), cold pressor test (CPT) | at baseline | |
| Primary | Functional assessment (questionnaires) | Questionnaires: PDI, SF-36 | at baseline | |
| Primary | 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 | |
| Primary | Pain assessment (questionnaire) | questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36) | at 6 months | |
| Primary | 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) | |
| Primary | Pain assessment (physical testing) | Physical testing: pressure pain threshold (PTT), cold pressor test (CPT) Time Frame: after 18 treatment sessions | at 3 months | |
| Primary | 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) | |
| Primary | Functional assessment (questionnaires) | Questionnaires: PDI, SF-36 Timeframe: after 3 treatment sessions (PDI) | at 1 week | |
| Primary | Functional assessment (questionnaires) | Questionnaires: PDI, SF-36 Time Frame: after 18 treatment sessions | at 3 months | |
| Primary | 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) | |
| Primary | Functional assessment (questionnaires) | Questionnaires: PDI, SF-36 | at 6 months | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | Psychological correlates | Psychological correlates: PCS, PVAQ, TSK, IPQ-R | at baseline | |
| Secondary | Neurophysiology of pain test (questionnaire) | Time Frame: after 3 treatment sessions Questionnaire: Dutch Neurophysiology of Pain Test (patient version) | at 1 week | |
| Secondary | Psychological correlates | Psychological correlates: PCS, PVAQ, TSK, IPQ-R Time Frame: after 3 treatment sessions | at 1 week | |
| Secondary | Psychological correlates | Psychological correlates: PCS, PVAQ, TSK, IPQ-R Time Frame: after 18 treatment sessions | at 3 months | |
| Secondary | Psychological correlates | Psychological correlates: PCS, PVAQ, TSK, IPQ-R | at 6 months | |
| Secondary | 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) | |
| Secondary | Muscle properties | Isometric muscle strength of spinal flexor and extensor muscles Endurance of spinal flexor and extensor muscles |
at baseline | |
| Secondary | 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 | |
| Secondary | 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) | |
| Secondary | 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) | |
| Secondary | 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 | |
| Secondary | 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) | |
| Secondary | 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 | |
| Secondary | 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 | |
| Secondary | 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) | |
| Secondary | 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
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