CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 120 enrolled
Drug / intervention
Modern pain neuroscience approach +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03239938
NCT03239938N/ACompleted

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?

Vrije Universiteit Brussel·interventional·Posted Aug 4, 2017·Updated Nov 28, 2022

In Brief

A clinical study evaluating Modern pain neuroscience approach and Usual care evidence-based physiotherapy for Whiplash. Completed, enrolled 120 participants across 3 sites.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsWhiplash
CountriesBelgium

Timeline

N/ACompletedFinished
201820192020202120222023202420252026
First PostedAug 4, 2017
Enrollment StartAug 17, 2017
Primary CompletionJun 13, 2022
TodayJul 2, 2026
Enrollment to primary: 4.8 yearsPosted 8.9 years ago

Interventions

Modern pain neuroscience approachbehavioral

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.

Usual care evidence-based physiotherapybehavioral

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.