Clinical trial NCT03239938: Modern Pain Neuroscience Applied to Chronic Pain in Patients With Chronic Whiplash Associated Disorders
Official title: Contemporary Pain Neuroscience Compared to Usual Care Evidence-based Physiotherapy Applied to Chronic Pain in Patients With Chronic Whiplash Associated Disorders: Can we Decrease Central Sensitization?
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Whiplash
Keywords: chronic whiplash associated disorders
central sensitization
electroencephalography
physiotherapy
chronic pain
functionality
quality of life
stress management
randomized controlled trial
modern neuroscience approach
pain neuroscience education
neck school
exercise therapy
pain cognitions
Lead sponsor: Vrije Universiteit Brussel
Sponsor class: OTHER
Collaborators: name: University Hospital, Ghent
name: University Ghent
name: Research Foundation Flanders
name: Universitair Ziekenhuis Brussel
First posted: 2017-08-04
Enrollment: 120
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The trial will randomize 120 patients with chronic WAD, aged between 18 and 65 years, to the experimental (modern neuroscience approach including 3 sessions of therapeutic pain neuroscience education followed by 15 sessions of dynamic and functional cognition-targeted exercise therapy and stress management techniques (n = 60)) or the control treatment (usual care physiotherapy: 3 sessions of neck school followed by 15 sessions of exercise therapy focusing on strength, flexibility, endurance, and ergonomic principles (n= 60)).
Primary purpose: TREATMENT

Brief summary: Modern pain neuroscience has advanced our understanding of chronic whiplash associated disorders (WAD). Previous studies have shown the importance of central sensitization, characterized by hypersensitivity of the somatosensory system, in explaining poor treatment outcome. Therefore, and to address the need for a better treatment of chronic WAD, we recently proposed a modern neuroscience approach to chronic WAD. Such approach includes two specific parts: therapeutic pain neuroscience education followed by dynamic and functional cognition-targeted exercise therapy and stress management techniques.

The primary scientific objective of the study entails examining the effectiveness of a modern neuroscience approach versus usual care evidence-based physiotherapy for reducing dysfunctioning in patients with chronic WAD. The secondary scientific objective of the study entails examining the effectiveness of a modern neuroscience approach versus usual care evidence-based physiotherapy for reducing pain, central sensitization, psychosocial problems, and socio-economic burden in patients with chronic WAD. The trial will randomize 120 patients with chronic WAD, aged between 18 and 65 years, to the experimental (modern pain neuroscience approach including 3 sessions of therapeutic pain neuroscience education followed by 15 sessions of dynamic and functional cognition-targeted exercise therapy and stress management techniques (n = 60)) or the control treatment (usual care physiotherapy including 3 sessions of neck school followed by 15 sessions of graded and active exercise therapy focusing on strength, flexibility, endurance, and ergonomic principles (n= 60)). The primary outcome measure is self-reported functional status. Secondary outcome measures include pain, health-related quality of life, psychological correlates, measures of central sensitization, and socio-economic factors. In addition, quantitative scalp Electroencephalography (EEG) to measure various parameters of brain activation will be performed during a conditioned pain modulation paradigm. Baseline assessment of all outcome measures will be performed.

Follow-up assessments will be performed immediately after 16 weeks of therapy (all tests), and 6 months (all tests) and 12 months (only questionnaires) after finishing the therapeutic intervention.

To investigate these objectives, a multi-center triple-blind randomized, controlled trial with 1 year follow up will be performed.

Detailed description: Modern pain neuroscience has advanced our understanding of chronic whiplash associated disorders (WAD). Previous studies have shown the importance of central sensitization, characterized by hypersensitivity of the somatosensory system, in explaining poor treatment outcome. Therefore, and to address the need for a better treatment of chronic WAD, we recently proposed a modern neuroscience approach to chronic WAD. Such approach includes two specific parts: 3 sessions of therapeutic pain neuroscience education followed by 15 sessions of dynamic and functional cognition-targeted exercise therapy and stress management techniques. The main principles of cognition-targeted are the following: All exercises should be performed in a time-contingent ("Perform this exercise 10 times, regardless of the pain") rather than in a symptom-contingent way ("Stop or adjust the exercise when it hurts"). Goal setting is essentially done together with the patient, focussing on functionality. The treating physical therapist should continuously assess and challenge the patients' cognitions and perceptions about the pain and the anticipated outcome of each exercise, to change maladaptive cognitions and perceptions into positive ones.

The primary scientific objective of the study entails examining the effectiveness of a modern pain neuroscience approach versus usual care evidence-based physiotherapy for reducing dysfunctioning in patients with chronic WAD. The secondary scientific objective of the study entails examining the effectiveness of a modern neuroscience approach versus usual care evidence-based physiotherapy for reducing pain, central sensitization, psychological problems, and socio-economic burden in patients with chronic WAD. The trial will randomize 120 patients with chronic WAD, aged between 18 and 65 years, to the experimental (modern pain neuroscience approach (n = 60)) or control treatment (usual care evidence-based physiotherapy: 3 sessions of neck school followed by 15 sessions of graded and active exercise therapy focusing on strength, flexibility, endurance, and ergonomic principles (n= 60)). The primary outcome measure is functional status. Secondary outcome measures include pain, health-related quality of life, psychological correlates, socio-economic factors, and measures of central sensitization, including electrical detection and electrical pain thresholds measured with a constant current electrical stimulator, endogenous pain facilitation (temporal summation of electrical pain), endogenous pain inhibition assessed by the conditioned pain modulation paradigm (electrical stimulation as test stimulus and the cold pressor test (immersion of one hand in cold water of 12°C) as conditioning stimulus). In addition, quantitative scalp Electroencephalography (EEG) to measure various parameters of brain activation will be performed during the conditioned pain modulation paradigm.

To comply with these scientific objectives, the 120 chronic WAD patients will be subjected to the baseline assessment of all outcome measures.

Follow-up assessments will be performed immediately after 16 weeks of therapy (all tests), and 6 months (all tests) and 12 months (only questionnaires) after finishing the therapeutic intervention.

To investigate these objectives, a muli-center triple-blind randomized, controlled trial with 1 year follow up will be performed.

Appropriate statistical analyses will be performed to evaluate and compare treatment effects. Statistical, as well as clinical significant differences will be defined and the effect size will be determined. Relations between functional status, pain, psychological correlates and central sensitization will be investigated. Furthermore, prediction of pain and functional status by central sensitization and psychological correlates will be performed in chronic WAD patients. Also, factors associated with clinically important changes in the outcome measures will be unraveled. In addition, factors associated with poor outcome following treatment will be assessed.

Eligibility criteria: Inclusion Criteria:

* Experienced a whiplash trauma which is at least 3 months old and causes pain since at least 3 months, with pain experience with a mean pain frequency of 3 or more days per week, and with self-reported moderate to severe pain-related disability, established by a score of 15 or more of a maximum of 50 on the Neck Disability Index
* Patients classified as WAD II or WAD III on the modified Quebec Task Force Scale
* Native Dutch speaker
* Not starting new treatments or medication and continuing their usual care 6 weeks prior to and during study participation (to obtain a steady state)
* Refraining from non-opioid analgesics in the previous 48h of the assessments
* Refraining from caffeine, alcohol, and nicotine in the previous 24h of the assessments

Exclusion Criteria:

* Neuropathic pain
* Being pregnant or having given birth in the preceding year
* Chronic fatigue syndrome
* Fibromyalgia
* Cardiovascular disorders
* Epilepsy
* Endocrinological disorders
* Rheumatic disorders
* Psychiatric disorders
* History of neck surgery
* Loss of consciousness during/after the whiplash trauma
* Post-traumatic amnesia

Primary outcomes:
measure: Self-reported functional status or disability
timeFrame: The change between the baseline assessment and the 6 months follow-up assessment (6 months after the end of the therapy)
Secondary outcomes:
measure: Self-reported functional status or disability
timeFrame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T3 follow-up assessment 12 months after the end of the therapy.
measure: Self-reported health-related quality of life
timeFrame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy, T3 assessment 12 months after the end of the therapy.
measure: Self-reported pain assessment
timeFrame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy, T3 follow-up assessment 12 months after the end of the therapy.
measure: Self-reported central sensitization symptoms
timeFrame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy, T3 follow-up assessment 12 months after the end of the therapy.
measure: Electrical detection and electrical pain thresholds with a constant current electrical stimulator (DS7A Digitimer)
timeFrame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy
measure: Endogenous pain facilitation assessed by a temporal summation paradigm
timeFrame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy
measure: Endogenous pain inhibition assessed by a conditioned pain modulation paradigm
timeFrame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy
measure: Quantitative Electroencephalography (QEEG) (Sienna digital EEG, EMS Biomedical, Korneuburg, Austria) will be recorded from 32 Sn surface electrodes using an electrode cap (Headcap, Expertise in Medical Solutions Biomedical, Korneuburg, Austria).
timeFrame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy
measure: Self-reported psychological correlates: Pain catastrophizing
timeFrame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy, T3 follow-up assessment 12 months after the end of the therapy.
measure: Self-reported psychological correlates: Illness perceptions
timeFrame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy, T3 follow-up assessment 12 months after the end of the therapy.
measure: Self-reported psychological correlates: Post-traumatic stress
timeFrame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy, T3 follow-up assessment 12 months after the end of the therapy.
measure: Self-reported psychological correlates: Pain-related fear and fear-avoidance behaviour
timeFrame: Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy, T3 follow-up assessment 12 months after the end of the therapy.
measure: Socio-economic factors
timeFrame: Baseline assessment, T2 follow-up assessment 6 months after the end of the therapy, T3 follow-up assessment 12 months after the end of the therapy, 1 year before enrollment in the study
Other outcomes:
Locations:
city: Bornem
country: Belgium
facility: Sint-jozefkliniek Campus Bornem (AZ Rivierenland)
state: Antwerpen
city: Ghent
country: Belgium
facility: Ghent University
state: Oost-Vlaanderen
city: Brussels
country: Belgium
facility: Vrije Universiteit Brussel
Study officials:
affiliation: Vrije Universiteit Brussel
name: Iris Coppieters, PhD
role: STUDY_DIRECTOR
affiliation: Vrije Universiteit Brussel
name: Jo Nijs, PhD
role: PRINCIPAL_INVESTIGATOR
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