title: Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: design of a randomised controlled trial.
abstract: BACKGROUND
  Many patients suffer from chronic neck pain following a whiplash injury. A combination of cognitive, behavioural therapy with physiotherapy interventions has been indicated to be effective in the management of patients with chronic whiplash-associated disorders. The objective is to present the design of a randomised controlled trial (RCT) aimed at evaluating the effectiveness of a combined individual physical and cognitive behavioural-graded activity program on self-reported general physical function, in addition to neck function, pain, disability and quality of life in patients with chronic neck pain following whiplash injury compared with a matched control group measured at baseline and 4 and 12 months after baseline.
  
  
  METHODS
  The design is a two-centre, RCT-study with a parallel group design. Included are whiplash patients with chronic neck pain for more than 6 months, recruited from physiotherapy clinics and an out-patient hospital department in Denmark. Patients will be randomised to either a pain management (control) group or a combined pain management and training (intervention)group. The control group will receive four educational sessions on pain management, whereas the intervention group will receive the same educational sessions on pain management plus 8 individual training sessions for 4 months, including guidance in specific neck exercises and an aerobic training programme. Patients and physiotherapists are aware of the allocation and the treatment, while outcome assessors and data analysts are blinded. The primary outcome measures will be Medical Outcomes Study Short Form 36 (SF36), Physical Component Summary (PCS). Secondary outcomes will be Global Perceived Effect (-5 to +5), Neck Disability Index (0-50), Patient Specific Functioning Scale (0-10), numeric rating scale for pain bothersomeness (0-10), SF-36 Mental Component Summary (MCS), TAMPA scale of Kinesiophobia (17-68), Impact of Event Scale (0-45), EuroQol (0-1), craniocervical flexion test (22 mmHg - 30 mmHg), joint position error test and cervical range of movement. The SF36 scales are scored using norm-based methods with PCS and MCS having a mean score of 50 with a standard deviation of 10.
  
  
  CONCLUSIONS
  The perspectives of this study are discussed, in addition to the strengths and weaknesses.
  
  
  BACKGROUND
  The study is registered in http://www.ClinicalTrials.gov identifier NCT01431261.
authors.affiliation: Research Unit for Musculoskeletal Function and Physiotherapy, Institute of Sports Science and Clinical Biomechanics, University of Southern Denmark, Odense M, Denmark. iris@health.sdu.dk
authors.forename: Inge Ris
authors.initials: IR
authors.lastname: Hansen
authors.forename: Karen
authors.initials: K
authors.lastname: Søgaard
authors.forename: Robin
authors.initials: R
authors.lastname: Christensen
authors.forename: Bente
authors.initials: B
authors.lastname: Thomsen
authors.forename: Claus
authors.initials: C
authors.lastname: Manniche
authors.forename: Birgit
authors.initials: B
authors.lastname: Juul-Kristensen
mesh_terms: D000328:Adult; D059350:Chronic Pain / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D015928:Cognitive Behavioral Therapy; D003131:Combined Modality Therapy; D003718:Denmark; D004185:Disability Evaluation; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D009334:Neck Muscles / Q000503:physiopathology*; D019547:Neck Pain / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*; D010147:Pain Measurement; D010353:Patient Education as Topic; D026741:Physical Therapy Modalities; D011788:Quality of Life; D012107:Research Design; D013997:Time Factors; D016896:Treatment Outcome; D014911:Whiplash Injuries / Q000175:diagnosis / Q000503:physiopathology / Q000523:psychology / Q000628:therapy*