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.
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
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.
- Conditions
- Chronic Spinal Pain
- 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 group | Role | What they receive |
|---|---|---|
| Usual care | Active comparator | usual care evidence-based physiotherapy Receives: Other: usual care evidence-based physiotherapy |
| modern neuroscience approach | Experimental | modern neuroscience approach Receives: Other: modern neuroscience approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain assessment (questionnaire)
questionnaire: numerical rating scale (NRS), central sensitization inventory (CSI), medical outcomes short form 36 health service (SF-36)
Measured: at baseline
Pain assessment (physical testing)
Physical testing: pressure pain threshold (PTT), cold pressor test (CPT)
Measured: at baseline
Functional assessment (questionnaires)
Questionnaires: PDI, SF-36
Measured: 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
Measured: at 3 months
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
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)
Pain assessment (physical testing)
Physical testing: pressure pain threshold (PTT), cold pressor test (CPT) Time Frame: after 18 treatment sessions
Measured: at 3 months
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)
Functional assessment (questionnaires)
Questionnaires: PDI, SF-36 Timeframe: after 3 treatment sessions (PDI)
Measured: at 1 week
Functional assessment (questionnaires)
Questionnaires: PDI, SF-36 Time Frame: after 18 treatment sessions
Measured: at 3 months
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)
Functional assessment (questionnaires)
Questionnaires: PDI, SF-36
Measured: at 6 months
Secondary outcomes (18)
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
Motor Control
- Postural steadiness
- Habitual standing posture
- Spinal range of motion
- Sensorimotor control
- 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
Psychological correlates
Psychological correlates: PCS, PVAQ, TSK, IPQ-R
Measured: at baseline
Neurophysiology of pain test (questionnaire)
Time Frame: after 3 treatment sessions Questionnaire: Dutch Neurophysiology of Pain Test (patient version)
Measured: at 1 week
Psychological correlates
Psychological correlates: PCS, PVAQ, TSK, IPQ-R Time Frame: after 3 treatment sessions
Measured: at 1 week
Psychological correlates
Psychological correlates: PCS, PVAQ, TSK, IPQ-R Time Frame: after 18 treatment sessions
Measured: at 3 months
Psychological correlates
Psychological correlates: PCS, PVAQ, TSK, IPQ-R
Measured: at 6 months
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)
Muscle properties
- Isometric muscle strength of spinal flexor and extensor muscles
- Endurance of spinal flexor and extensor muscles
Measured: 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
Measured: at 3 months
Muscle properties
- Isometric muscle strength of spinal flexor and extensor muscles
- 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)
Motor Control
- Postural steadiness
- Habitual standing posture
- Spinal range of motion
- Sensorimotor control
- 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)
Motor Control
- Postural steadiness
- Habitual standing posture
- Spinal range of motion
- Sensorimotor control
- 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
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)
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
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
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)
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.
- First posted27 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionApr 2016
- Study completionApr 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Chronic Spinal PainStudies of the same condition, open and under way.
- More trials run by University GhentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- University Ghent
- Sponsor type
- University, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie, Vrije Universiteit Brussel, University Hospital, Ghent
- Responsible party
- Sponsor
- Investigators
- Lieven Danneels, MD, PhD, Principal investigator, University GhentJo Nijs, MD, PhD, Principal investigator, Vrije Universiteit Brussel
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 37871684Van 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 33611503Willaert 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 32187789Lenoir 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 31605983Malfliet 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 29710099Malfliet 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 29669079Dolphens 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
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Modern Neuroscience Approach to Chronic Spinal Pain: Pain Neuroscience Education Combined With Cognition-targeted Motor Control Training
- ClinicalTrials.gov ID
- NCT02098005
- Acronym / sponsor ID
- EC/2013/1133
- Conditions
- Chronic Spinal Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University GhentUniversity, hospital or other
- Collaborators
- Agentschap voor Innovatie door Wetenschap en Technologie, Vrije Universiteit Brussel, University Hospital, Ghent
- Study start
- Jan 2014
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 27 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care | Active comparator | Other: usual care evidence-based physiotherapyusual care evidence-based physiotherapy |
| modern neuroscience approach | Experimental | Other: modern neuroscience approachmodern neuroscience approach |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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)
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usual care evidence-based physiotherapyArm 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. | Other | Usual care |
| modern neuroscience approachArm 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. | Other | modern neuroscience approach |
Primary outcome
Pain assessment (questionnaire)
Time frame: at baseline
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
Physical testing: pressure pain threshold (PTT), cold pressor test (CPT)
Functional assessment (questionnaires)
Time frame: at baseline
Questionnaires: PDI, SF-36
Pain assessment (questionnaire)
Time frame: at 3 months
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
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)
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
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)
Physical testing: pressure pain threshold (PTT), cold pressor test (CPT)
Functional assessment (questionnaires)
Time frame: at 1 week
Questionnaires: PDI, SF-36 Timeframe: after 3 treatment sessions (PDI)
Functional assessment (questionnaires)
Time frame: at 3 months
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)
Questionnaires: PDI, SF-36
Functional assessment (questionnaires)
Time frame: at 6 months
Questionnaires: PDI, SF-36
18 secondary outcomes
Gray and white matter structure
Time frame: at baseline
Motor Control
Time frame: at baseline
Psychological correlates
Time frame: at baseline
Neurophysiology of pain test (questionnaire)
Time frame: at 1 week
Psychological correlates
Time frame: at 1 week
Psychological correlates
Time frame: at 3 months
Psychological correlates
Time frame: at 6 months
Psychological correlates
Time frame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)
Muscle properties
Time frame: at baseline
Muscle properties
Time frame: at 3 months
Muscle properties
Time frame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)
Motor Control
Time frame: at 12 months (except when no treatment effects would be found at 6 months: go/no go principle)
Motor Control
Time frame: at 3 months
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)
Gray and white matter function
Time frame: at 3 months
Gray and white matter structure
Time frame: at 3 months
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)
Gray and white matter function
Time frame: at baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2017.
- Derived from this study: PubMed 37871684Van 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.
- Derived from this study: PubMed 33611503Van 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.
- Derived from this study: PubMed 32187789Willaert 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.
- Derived from this study: PubMed 31605983Lenoir 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.
- Derived from this study: PubMed 29710099Malfliet 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.
- Derived from this study: PubMed 29669079Malfliet 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.
- Derived from this study: PubMed 24885889Dolphens 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.
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Chronic Low Back Pain, Spinal Cord Injury
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Virtual Reality-Based Hypnotherapy for Pain, Sleep, and Mood in Spinal Cord Injury
Spinal Cord Injuries (SCI), Chronic Pain
Not yet recruiting
Virtual Pain Education for Spinal Cord Stimulation Patients
Chronic Pain, Chronic Pain Due to Injury
Active, not recruiting
Transcranial Magnetic Stimulation for Chronic Neuropathic Pain
Chronic Neuropathic Pain, Post-Stroke Pain
Active, not recruiting
A 5-year Superion™ IDS Clinical Outcomes Post-Approval Evaluation (SCOPE)
Lumbar Spinal Stenosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lieven Danneels, MD, PhD principal investigator
University Ghent
Jo Nijs, MD, PhD principal investigator
Vrije Universiteit Brussel
3 sites in 1 country: see every site and its status.
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.