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Open Access Highly Accessed Study protocol

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

Mieke Dolphens1*, Jo Nijs23, Barbara Cagnie1, Mira Meeus14, Nathalie Roussel24, Jeroen Kregel12, Anneleen Malfliet123, Guy Vanderstraeten15 and Lieven Danneels1

Author Affiliations

1 Department of Rehabilitation Sciences and Physiotherapy, Ghent University, Campus Heymans (UZ, 3B3), De Pintelaan 185, 9000 Ghent, Belgium

2 Pain in Motion Research Group, Departments of Human Physiology and Physiotherapy, Faculty of Physical Education & Physiotherapy, Vrije Universiteit Brussels, Brussels, Belgium

3 Department of Physical Medicine and Physiotherapy, University Hospital Brussels, Brussels, Belgium

4 Pain in Motion Research Group, Rehabilitation Sciences and Physiotherapy, Faculty of Medicine and Health Sciences, Universiteit Antwerpen, Antwerpen, Belgium

5 Department of Physical and Rehabilitation Medicine, Ghent University, Ghent, Belgium

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BMC Musculoskeletal Disorders 2014, 15:149  doi:10.1186/1471-2474-15-149

Published: 8 May 2014

Abstract

Background

Among the multiple conservative modalities, physiotherapy is a commonly utilized treatment modality in managing chronic non-specific spinal pain. Despite the scientific progresses with regard to pain and motor control neuroscience, treatment of chronic spinal pain (CSP) often tends to stick to a peripheral biomechanical model, without targeting brain mechanisms. With a view to enhance clinical efficacy of existing physiotherapeutic treatments for CSP, the development of clinical strategies targeted at ‘training the brain’ is to be pursued. Promising proof-of-principle results have been reported for the effectiveness of a modern neuroscience approach to CSP when compared to usual care, but confirmation is required in a larger, multi-center trial with appropriate evidence-based control intervention and long-term follow-up.

The aim of this study is to assess the effectiveness of a modern neuroscience approach, compared to usual care evidence-based physiotherapy, for reducing pain and improving functioning in patients with CSP. A secondary objective entails examining the effectiveness of the modern neuroscience approach versus usual care physiotherapy for normalizing brain gray matter in patients with CSP.

Methods/Design

The study is a multi-center, triple-blind, two-arm (1:1) randomized clinical trial with 1-year follow-up. 120 CSP patients will be randomly allocated to either the experimental (receiving pain neuroscience education followed by cognition-targeted motor control training) or the control group (receiving usual care physiotherapy), each comprising of 3 months treatment. The main outcome measures are pain (including symptoms and indices of central sensitization) and self-reported disability. Secondary outcome measures include brain gray matter structure, motor control, muscle properties, and psychosocial correlates. Clinical assessment and brain imaging will be performed at baseline, post-treatment and at 1-year follow-up. Web-based questionnaires will be completed at baseline, after the first 3 treatment sessions, post-treatment, and at 6 and 12-months follow-up.

Discussion

Findings may provide empirical evidence on: (1) the effectiveness of a modern neuroscience approach to CSP for reducing pain and improving functioning, (2) the effectiveness of a modern neuroscience approach for normalizing brain gray matter in CSP patients, and (3) factors associated with therapy success. Hence, this trial might contribute towards refining guidelines for good clinical practice and might be used as a basis for health authorities’ recommendations.

Trial registration

ClinicalTrials.gov Identifier: NCT02098005.

Keywords:
Chronic pain; Low back pain; Neck pain; Education; Exercise; Motor control; Neuroscience; Randomized controlled trial