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

This study is currently recruiting participants. (see Contacts and Locations)
Verified March 2014 by University Ghent
Sponsor:
Collaborators:
Agentschap voor Innovatie door Wetenschap en Technologie
Vrije Universiteit Brussel
University Hospital, Ghent
Information provided by (Responsible Party):
University Ghent
ClinicalTrials.gov Identifier:
NCT02098005
First received: March 17, 2014
Last updated: March 26, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention
Chronic Spinal Pain.
Other: usual care evidence-based physiotherapy
Other: modern neuroscience approach

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Modern Neuroscience Approach to Chronic Spinal Pain: Pain Neuroscience Education Combined With Cognition-targeted Motor Control Training

Further study details as provided by University Ghent:

Primary Outcome Measures:
  • Pain assessment (questionnaire) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36)

  • Pain assessment (physical testing) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Physical testing: pressure pain threshold (PTT), cold pressor test (CPT)

  • Functional assessment (questionnaires) [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Questionnaires: PDI, SF-36

  • Pain assessment (questionnaire) [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
    questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36) Time Frame: after 18 treatment sessions

  • Pain assessment (questionnaire) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36)

  • Pain assessment (questionnaire) [ Time Frame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) ] [ Designated as safety issue: No ]
    questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36)

  • Pain assessment (physical testing) [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
    Physical testing: pressure pain threshold (PTT), cold pressor test (CPT) Time Frame: after 18 treatment sessions

  • Pain assessment (physical testing) [ Time Frame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) ] [ Designated as safety issue: No ]
    Physical testing: pressure pain threshold (PTT), cold pressor test (CPT)

  • Functional assessment (questionnaires) [ Time Frame: at 1 week ] [ Designated as safety issue: No ]
    Questionnaires: PDI, SF-36 Timeframe: after 3 treatment sessions (PDI)

  • Functional assessment (questionnaires) [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
    Questionnaires: PDI, SF-36 Time Frame: after 18 treatment sessions

  • Functional assessment (questionnaires) [ Time Frame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) ] [ Designated as safety issue: No ]
    Questionnaires: PDI, SF-36

  • Functional assessment (questionnaires) [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    Questionnaires: PDI, SF-36


Secondary Outcome Measures:
  • Gray and white matter structure [ Time Frame: at baseline ] [ Designated as safety issue: No ]

    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


  • Motor Control [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    1. Postural steadiness
    2. Habitual standing posture
    3. Spinal range of motion
    4. 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


  • Psychological correlates [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    Psychological correlates: PCS, PVAQ, TSK, IPQ-R

  • Neurophysiology of pain test (questionnaire) [ Time Frame: at 1 week ] [ Designated as safety issue: No ]
    Time Frame: after 3 treatment sessions Questionnaire: Dutch Neurophysiology of Pain Test (patient version)

  • Psychological correlates [ Time Frame: at 1 week ] [ Designated as safety issue: No ]
    Psychological correlates: PCS, PVAQ, TSK, IPQ-R Time Frame: after 3 treatment sessions

  • Psychological correlates [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
    Psychological correlates: PCS, PVAQ, TSK, IPQ-R Time Frame: after 18 treatment sessions

  • Psychological correlates [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    Psychological correlates: PCS, PVAQ, TSK, IPQ-R

  • Psychological correlates [ Time Frame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) ] [ Designated as safety issue: No ]
    Psychological correlates: PCS, PVAQ, TSK, IPQ-R

  • Muscle properties [ Time Frame: at baseline ] [ Designated as safety issue: No ]
    1. Isometric muscle strength of spinal flexor and extensor muscles
    2. Endurance of spinal flexor and extensor muscles

  • Muscle properties [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
    1. Isometric muscle strength of spinal flexor and extensor muscles
    2. Endurance of spinal flexor and extensor muscles

    Time Frame: after 18 treatment sessions


  • Muscle properties [ Time Frame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) ] [ Designated as safety issue: No ]
    1. Isometric muscle strength of spinal flexor and extensor muscles
    2. Endurance of spinal flexor and extensor muscles

  • Motor Control [ Time Frame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) ] [ Designated as safety issue: No ]
    1. Postural steadiness
    2. Habitual standing posture
    3. Spinal range of motion
    4. 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


  • Motor Control [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
    1. Postural steadiness
    2. Habitual standing posture
    3. Spinal range of motion
    4. 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


  • Gray and white matter structure [ Time Frame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) ] [ Designated as safety issue: No ]

    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


  • Gray and white matter function [ Time Frame: at 3 months ] [ Designated as safety issue: No ]

    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


  • Gray and white matter structure [ Time Frame: at 3 months ] [ Designated as safety issue: No ]

    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


  • Gray and white matter function [ Time Frame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle) ] [ Designated as safety issue: No ]

    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


  • Gray and white matter function [ Time Frame: at baseline ] [ Designated as safety issue: No ]

    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



Estimated Enrollment: 120
Study Start Date: January 2014
Estimated Study Completion Date: May 2016
Estimated Primary Completion Date: May 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Usual care
usual care evidence-based physiotherapy
Other: usual care evidence-based physiotherapy
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.
Experimental: modern neuroscience approach
modern neuroscience approach
Other: modern neuroscience approach
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.

  Eligibility

Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02098005

Contacts
Contact: Mieke Dolphens, PT-PhD +32 9 332 55 03 mieke.dolphens@ugent.be

Locations
Belgium
Ghent University Hospital Recruiting
Ghent, Belgium, 9000
Principal Investigator: Erik Achten, MD, PhD         
Universiteit Gent (UGent), Faculty of Medicine and Health Sciences, Dpt. Of Rehabilitation Sciences and Physiotherapy, BE-9000 Gent (Belgium) Recruiting
Ghent, Belgium, 9000
Contact: Lieven Danneels, MD, Phd         
Principal Investigator: Lieven Danneels, MD, PhD         
Sub-Investigator: Mieke Dolphens, PT-PhD         
Sub-Investigator: Jeroen Kregel         
Vrije Universiteit Brussel, Faculty of Physical Education & Physiotherapy, Dpt. of Rehabilitation Sciences & Physiotherapy Recruiting
Jette, Belgium, 1090
Principal Investigator: Jo Nijs, MD, PhD         
Sub-Investigator: Anneleen Malfiet         
Sponsors and Collaborators
University Ghent
Agentschap voor Innovatie door Wetenschap en Technologie
Vrije Universiteit Brussel
University Hospital, Ghent
Investigators
Principal Investigator: Lieven Danneels, MD, PhD Universiteit Gent
Principal Investigator: Jo Nijs, MD, PhD Vrije Universiteit Brussel
  More Information

No publications provided by University Ghent

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: University Ghent
ClinicalTrials.gov Identifier: NCT02098005     History of Changes
Other Study ID Numbers: EC/2013/1133
Study First Received: March 17, 2014
Last Updated: March 26, 2014
Health Authority: Belgium: Ethics Committee

ClinicalTrials.gov processed this record on November 27, 2014