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Chronic Spinal PainNCT02098005

Pain Neuroscience Education Combined With Cognition-targeted Motor Control Training

A study testing modern neuroscience approach in people with Chronic Spinal Pain, run by University Ghent at 3 sites in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Chronic Spinal Pain
What is being tested?
modern neuroscience approach
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
3 sitesBelgium
Study dates
Jan 2014to Apr 2016
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • 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

Who cannot join

  • 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

Trial locations and contacts

3 sites in 1 country.

Belgium3 sites
  • Ghent University Hospital

    Ghent, 9000

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

    Ghent, 9000

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

    Jette, 1090

Other trials in Belgium

About this study

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.

Read more

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.

Being tested
usual care evidence-based physiotherapy, modern neuroscience approach

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • usual care evidence-based physiotherapyOther

    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.

  • modern neuroscience approachOther

    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.

Study groups in NCT02098005
Study groupRoleWhat they receive
Usual careActive comparatorusual care evidence-based physiotherapy
Receives: Other: usual care evidence-based physiotherapy
modern neuroscience approachExperimentalmodern neuroscience approach
Receives: Other: modern neuroscience approach

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain assessment (questionnaire)

    questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36)

    Measured: at baseline

  2. Pain assessment (physical testing)

    Physical testing: pressure pain threshold (PTT), cold pressor test (CPT)

    Measured: at baseline

  3. Functional assessment (questionnaires)

    Questionnaires: PDI, SF-36

    Measured: at baseline

  4. 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

    Measured: at 3 months

  5. Pain assessment (questionnaire)

    questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36)

    Measured: at 6 months

  6. Pain assessment (questionnaire)

    questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36)

    Measured: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)

  7. Pain assessment (physical testing)

    Physical testing: pressure pain threshold (PTT), cold pressor test (CPT) Time Frame: after 18 treatment sessions

    Measured: at 3 months

  8. Pain assessment (physical testing)

    Physical testing: pressure pain threshold (PTT), cold pressor test (CPT)

    Measured: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)

  9. Functional assessment (questionnaires)

    Questionnaires: PDI, SF-36 Timeframe: after 3 treatment sessions (PDI)

    Measured: at 1 week

  10. Functional assessment (questionnaires)

    Questionnaires: PDI, SF-36 Time Frame: after 18 treatment sessions

    Measured: at 3 months

  11. Functional assessment (questionnaires)

    Questionnaires: PDI, SF-36

    Measured: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)

  12. Functional assessment (questionnaires)

    Questionnaires: PDI, SF-36

    Measured: at 6 months

Secondary outcomes (18)
  1. 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

    Measured: at baseline

  2. Motor Control

    1. Postural steadiness
    2. Habitual standing posture
    3. Spinal range of motion
    4. Sensorimotor control
    5. 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

    Measured: at baseline

  3. Psychological correlates

    Psychological correlates: PCS, PVAQ, TSK, IPQ-R

    Measured: at baseline

  4. Neurophysiology of pain test (questionnaire)

    Time Frame: after 3 treatment sessions Questionnaire: Dutch Neurophysiology of Pain Test (patient version)

    Measured: at 1 week

  5. Psychological correlates

    Psychological correlates: PCS, PVAQ, TSK, IPQ-R Time Frame: after 3 treatment sessions

    Measured: at 1 week

  6. Psychological correlates

    Psychological correlates: PCS, PVAQ, TSK, IPQ-R Time Frame: after 18 treatment sessions

    Measured: at 3 months

  7. Psychological correlates

    Psychological correlates: PCS, PVAQ, TSK, IPQ-R

    Measured: at 6 months

  8. Psychological correlates

    Psychological correlates: PCS, PVAQ, TSK, IPQ-R

    Measured: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)

  9. Muscle properties

    1. Isometric muscle strength of spinal flexor and extensor muscles
    2. Endurance of spinal flexor and extensor muscles

    Measured: at baseline

  10. Muscle properties

    1. Isometric muscle strength of spinal flexor and extensor muscles
    2. Endurance of spinal flexor and extensor muscles

    Time Frame: after 18 treatment sessions

    Measured: at 3 months

  11. Muscle properties

    1. Isometric muscle strength of spinal flexor and extensor muscles
    2. Endurance of spinal flexor and extensor muscles

    Measured: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)

  12. Motor Control

    1. Postural steadiness
    2. Habitual standing posture
    3. Spinal range of motion
    4. Sensorimotor control
    5. 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

    Measured: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)

  13. Motor Control

    1. Postural steadiness
    2. Habitual standing posture
    3. Spinal range of motion
    4. Sensorimotor control
    5. 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

    Measured: at 3 months

  14. 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

    Measured: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)

  15. 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

    Measured: at 3 months

  16. 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

    Measured: at 3 months

  17. 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

    Measured: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)

  18. 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

    Measured: at baseline

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2014 (estimated)
  2. Study startJan 2014
  3. Primary completionApr 2016
  4. Study completionApr 2016

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02098005
Sponsor's protocol ID
EC/2013/1133
Status last verified
May 2017
First submitted
17 Mar 2014
Last updated
8 May 2017
Results posted
No
Data monitoring committee
No

Publications

  • 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.

    PubMed 37871684
  • 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.

    PubMed 33611503
  • 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.

    PubMed 32187789
  • 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.

    PubMed 31605983
  • 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.

    PubMed 29710099
  • 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.

    PubMed 29669079
  • 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.

    PubMed 24885889

Questions about this trial

What is this clinical trial studying?

A study testing modern neuroscience approach in people with Chronic Spinal Pain, run by University Ghent at 3 sites in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 8 May 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Pain assessment (questionnaire) (time frame: at baseline). The study lists 12 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02098005, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 May 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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