Modern Pain Neuroscience Applied to Chronic Pain in Patients With Chronic Whiplash Associated Disorders
Condition: Whiplash
MeSH terms: Chronic Pain; Whiplash Injuries
Study type: Interventional

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.
    

Intervention name(s): Modern pain neuroscience approach; Usual care evidence-based physiotherapy
Intervention type(s): Behavioral; Behavioral
Intervention description(s): The modern pain neuroscience approach includes 3 sessions (1 group and 2 individual sessions) of therapeutic pain neuroscience education followed by 15 individual sessions of dynamic and functional cognition-targeted exercise therapy and stress management techniques. In addition, participants will be instructed to perform a daily set of home exercises. The exercises will be performed in a time-contingent way. The 18 sessions will be spread over a period of 16 weeks.; The usual care evidence-based physiotherapy includes 3 sessions (1 group and 2 individual sessions) of neck school followed by 15 individual sessions of graded and active exercise therapy focusing on strength, flexibility, endurance, and ergonomic principles. In addition, participants will be instructed to perform a daily set of home exercises. The exercises will be performed in a symptom-contingent way. The 18 sessions will be spread over a period of 16 weeks.
Allocation: Randomized
Intervention model: Parallel Assignment
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)).
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Treatment
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