title: 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.
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
  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.
  
  
  CONCLUSIONS
  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.
  
  
  BACKGROUND
  ClinicalTrials.gov Identifier: NCT02098005.
authors.affiliation: Department of Rehabilitation Sciences and Physiotherapy, Ghent University, Campus Heymans (UZ, 3B3), De Pintelaan 185, 9000 Ghent, Belgium. Mieke.Dolphens@UGent.be.
authors.forename: Mieke
authors.initials: M
authors.lastname: Dolphens
authors.forename: Jo
authors.initials: J
authors.lastname: Nijs
authors.forename: Barbara
authors.initials: B
authors.lastname: Cagnie
authors.forename: Mira
authors.initials: M
authors.lastname: Meeus
authors.forename: Nathalie
authors.initials: N
authors.lastname: Roussel
authors.forename: Jeroen
authors.initials: J
authors.lastname: Kregel
authors.forename: Anneleen
authors.initials: A
authors.lastname: Malfliet
authors.forename: Guy
authors.initials: G
authors.lastname: Vanderstraeten
authors.forename: Lieven
authors.initials: L
authors.lastname: Danneels
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D001921:Brain / Q000473:pathology*; D059350:Chronic Pain / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D006233:Persons with Disabilities / Q000523:psychology / Q000534:rehabilitation*; D004311:Double-Blind Method; D019317:Evidence-Based Medicine / Q000379:methods*; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D017116:Low Back Pain / Q000175:diagnosis / Q000523:psychology / Q000628:therapy*; D008297:Male; D008875:Middle Aged; D026741:Physical Therapy Modalities / Q000523:psychology; D016896:Treatment Outcome; D055815:Young Adult