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BMC Musculoskeletal Disorders
Published in: BMC Musculoskeletal Disorders 1/2011

Open Access 01-12-2011 | Study protocol

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

Authors: Inge Ris Hansen, Karen Søgaard, Robin Christensen, Bente Thomsen, Claus Manniche, Birgit Juul-Kristensen

Published in: BMC Musculoskeletal Disorders | Issue 1/2011

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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/Design

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.

Discussion

The perspectives of this study are discussed, in addition to the strengths and weaknesses.

Trial registration

The study is registered in http://​www.​ClinicalTrials.​gov identifier NCT01431261.
Appendix
Available only for authorised users
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Metadata
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
Authors
Inge Ris Hansen
Karen Søgaard
Robin Christensen
Bente Thomsen
Claus Manniche
Birgit Juul-Kristensen
Publication date
01-12-2011
Publisher
BioMed Central
Published in
BMC Musculoskeletal Disorders / Issue 1/2011
Electronic ISSN: 1471-2474
DOI
https://doi.org/10.1186/1471-2474-12-274

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