Modern Pain Neuroscience Applied to Chronic Pain in Patients With Chronic Whiplash Associated Disorders

Sponsor

Vrije Universiteit Brussel (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT03239938

Collaborator

University Hospital, Ghent (Other), University Ghent (Other), Research Foundation Flanders (Other), Universitair Ziekenhuis Brussel (Other)

120

Enrollment

Locations

Arms

49.4

Anticipated Duration (Months)

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Whiplash	Behavioral: Modern pain neuroscience approach Behavioral: Usual care evidence-based physiotherapy	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

120 participants

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)).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

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?

Actual Study Start Date :

Aug 17, 2017

Anticipated Primary Completion Date :

Sep 30, 2021

Anticipated Study Completion Date :

Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Modern pain neuroscience approach Modern pain neuroscience approach	Behavioral: Modern pain neuroscience approach 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.
Active Comparator: Usual care evidence-based physiotherapy Usual care physiotherapy	Behavioral: Usual care evidence-based physiotherapy 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.

Arm

Intervention/Treatment

Experimental: Modern pain neuroscience approach

Modern pain neuroscience approach

Behavioral: Modern pain neuroscience approach

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.

Active Comparator: Usual care evidence-based physiotherapy

Usual care physiotherapy

Behavioral: Usual care evidence-based physiotherapy

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.

Outcome Measures

Primary Outcome Measures

Self-reported functional status or disability [The change between the baseline assessment and the 6 months follow-up assessment (6 months after the end of the therapy)]
The Dutch version of the Neck Disability Index (questionnaire)

Secondary Outcome Measures

Self-reported functional status or disability [Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T3 follow-up assessment 12 months after the end of the therapy.]
The Dutch version of the Neck Disability Index (questionnaire)
Self-reported health-related quality of life [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.]
The Dutch version of the Short Form Health Survey-36 items (questionnaire)
Self-reported pain assessment [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.]
A 0-10 Numeric Rating Scale for pain (questionnaire). Patients fill out the Numeric Rating Scale (0 no pain - 10 worst pain imaginable) for their perceived neck pain.
Self-reported central sensitization symptoms [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.]
The Dutch version of the Central Sensitization Inventory (questionnaire)
Electrical detection and electrical pain thresholds with a constant current electrical stimulator (DS7A Digitimer) [Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy]
Determination of the electrical detection and electrical pain threshold with the electrical stimulator will be performed at the sural nerve of the dominant leg and at the median nerve of the dominant arm.
Endogenous pain facilitation assessed by a temporal summation paradigm [Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy]
Temporal summation of electrical pain will be assessed by delivering 20 electrical stimuli at the intensity of the electrical pain threshold.
Endogenous pain inhibition assessed by a conditioned pain modulation paradigm [Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy]
Conditioned pain modulation will be tested with electrical stimulation as test stimulus and the cold pressor test (immersion the hand up to the wrist in cold water of 12°C) as conditioning stimulus.
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). [Baseline assessment, T1 follow-up assessment after 16 weeks of therapy, T2 follow-up assessment 6 months after the end of the therapy]
During the condition pain modulation paradigm a QEEG will be administered to examine various brain activity parameters.
Self-reported psychological correlates: Pain catastrophizing [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.]
The Dutch version of the Pain Catastrophizing Scale (questionnaire)
Self-reported psychological correlates: Illness perceptions [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.]
The Dutch version of the illness perception questionnaire-revised (questionnaire)
Self-reported psychological correlates: Post-traumatic stress [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.]
The Dutch version of the Impact of Event Scale revised (questionnaire)
Self-reported psychological correlates: Pain-related fear and fear-avoidance behaviour [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.]
The Dutch version of the Pain anxiety symptoms scale (PASS-20) (questionnaire)
Socio-economic factors [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]
Self-reported questionnaire and data including health-care expenditure from publicly funded healthcare organizations.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Sint-jozefkliniek Campus Bornem (AZ Rivierenland)	Bornem	Antwerpen	Belgium	2880
2	Ghent University	Ghent	Oost-Vlaanderen	Belgium	9000
3	Vrije Universiteit Brussel	Brussels		Belgium	1000