Pain Neuroscience Education Combined With Cognition-targeted Motor Control Training

NCT02098005 | Completed

• 1 other identifier: EC/2013/1133
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 3

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.

Conditions

Chronic Spinal Pain

Outcome Measures

Primary Outcomes (12)

• 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 Outcomes (18)

• Gray and white matter structure

  at baseline

• Motor Control

  at baseline

• Psychological correlates

  at baseline

• Neurophysiology of pain test (questionnaire)

  at 1 week

• Psychological correlates

  at 1 week

Study Arms (2)

Usual care

ACTIVE COMPARATOR

usual care evidence-based physiotherapy

Other: usual care evidence-based physiotherapy

modern neuroscience approach

EXPERIMENTAL

modern neuroscience approach

Other: modern neuroscience approach

Interventions

usual care evidence-based physiotherapy OTHER

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.

Usual care

modern neuroscience approach OTHER

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.

modern neuroscience approach

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University Ghent: lead
• Agentschap voor Innovatie door Wetenschap en Technologie: collaborator
• Vrije Universiteit Brussel: collaborator
• University Hospital, Ghent: collaborator

Study Sites (3)

Ghent University Hospital

Ghent, 9000, Belgium

Location

Universiteit Gent (UGent), Faculty of Medicine and Health Sciences, Dpt. Of Rehabilitation Sciences and Physiotherapy, BE-9000 Gent (Belgium)

Ghent, 9000, Belgium

Location

Vrije Universiteit Brussel, Faculty of Physical Education & Physiotherapy, Dpt. of Rehabilitation Sciences & Physiotherapy

Jette, 1090, Belgium

Location

Related Publications (7)

• Van Bogaert W, Liew BXW, Fernandez-de-Las-Penas C, Valera-Calero JA, Varol U, Coppieters I, Kregel J, Nijs J, Meeus M, Cagnie B, Danneels L, Malfliet A. Exploring Interactions Between Sex, Pain Characteristics, Disability, and Quality of Life in People With Chronic Spinal Pain: A Structural Equation Model. J Pain. 2024 Mar;25(3):791-804. doi: 10.1016/j.jpain.2023.10.010. Epub 2023 Oct 21.

  PMID: 37871684 DERIVED

• 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.

  PMID: 33611503 DERIVED

• 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.

  PMID: 32187789 DERIVED

• 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.

  PMID: 31605983 DERIVED

• 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.

  PMID: 29710099 DERIVED

• 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.

  PMID: 29669079 DERIVED

• 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.

  PMID: 24885889 DERIVED

Study Officials

• Lieven Danneels, MD, PhD

  University Ghent

  PRINCIPAL INVESTIGATOR

• Jo Nijs, MD, PhD

  Vrije Universiteit Brussel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 17, 2014
• First Posted: March 27, 2014
• Study Start: January 1, 2014
• Primary Completion: April 1, 2016
• Study Completion: April 1, 2016
• Last Updated: May 8, 2017

Record last verified: 2017-05

Locations

BE (3)