Pain Neuroscience Education Combined With Cognition-targeted Motor Control Training

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.

Study Overview

• Status: Completed
• Conditions: Chronic Spinal Pain
• Intervention / Treatment: Other: usual care evidence-based physiotherapy; Other: modern neuroscience approach

• Study Type: Interventional
• Enrollment (Actual): 120
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Belgium
  • Ghent, Belgium, 9000
    • Ghent University Hospital
  • Ghent, Belgium, 9000
    • Universiteit Gent (UGent), Faculty of Medicine and Health Sciences, Dpt. Of Rehabilitation Sciences and Physiotherapy, BE-9000 Gent (Belgium)
  • Jette, Belgium, 1090
    • Vrije Universiteit Brussel, Faculty of Physical Education & Physiotherapy, Dpt. of Rehabilitation Sciences & Physiotherapy

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Ghent
• Collaborators: University Hospital, Ghent; Agentschap voor Innovatie door Wetenschap en Technologie; Vrije Universiteit Brussel
• Investigators: Principal Investigator: Lieven Danneels, MD, PhD, University Ghent; Principal Investigator: Jo Nijs, MD, PhD, Vrije Universiteit Brussel

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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. Erratum In: JAMA Neurol. 2019 Mar 1;76(3):373.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 17, 2014
• First Submitted That Met QC Criteria: March 26, 2014
• First Posted (Estimate): March 27, 2014

Study Record Updates

• Last Update Posted (Actual): May 8, 2017
• Last Update Submitted That Met QC Criteria: May 3, 2017
• Last Verified: May 1, 2017

More Information

Terms related to this study

• Other Study ID Numbers: EC/2013/1133