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

<p>Abstract</p> <p>Background</p> <p>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 w...

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Main Authors: Hansen Inge, Søgaard Karen, Christensen Robin, Thomsen Bente, Manniche Claus, Juul-Kristensen Birgit
Format: Article
Language:English
Published: BMC 2011-12-01
Series:BMC Musculoskeletal Disorders
Online Access:http://www.biomedcentral.com/1471-2474/12/274
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author Hansen Inge
Søgaard Karen
Christensen Robin
Thomsen Bente
Manniche Claus
Juul-Kristensen Birgit
author_facet Hansen Inge
Søgaard Karen
Christensen Robin
Thomsen Bente
Manniche Claus
Juul-Kristensen Birgit
author_sort Hansen Inge
collection DOAJ
description <p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>The perspectives of this study are discussed, in addition to the strengths and weaknesses.</p> <p>Trial registration</p> <p>The study is registered in <url>http://www.ClinicalTrials.gov</url> identifier <a href="http://www.clinicaltrials.gov/ct2/show/NCT01431261">NCT01431261</a>.</p>
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spelling doaj.art-31f9b86b83964a6f962a85448b784ff22022-12-21T22:40:23ZengBMCBMC Musculoskeletal Disorders1471-24742011-12-0112127410.1186/1471-2474-12-274Neck exercises, physical and cognitive behavioural-graded activity as a treatment for adult whiplash patients with chronic neck pain: Design of a randomised controlled trialHansen IngeSøgaard KarenChristensen RobinThomsen BenteManniche ClausJuul-Kristensen Birgit<p>Abstract</p> <p>Background</p> <p>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.</p> <p>Methods/Design</p> <p>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.</p> <p>Discussion</p> <p>The perspectives of this study are discussed, in addition to the strengths and weaknesses.</p> <p>Trial registration</p> <p>The study is registered in <url>http://www.ClinicalTrials.gov</url> identifier <a href="http://www.clinicaltrials.gov/ct2/show/NCT01431261">NCT01431261</a>.</p>http://www.biomedcentral.com/1471-2474/12/274
spellingShingle Hansen Inge
Søgaard Karen
Christensen Robin
Thomsen Bente
Manniche Claus
Juul-Kristensen Birgit
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
BMC Musculoskeletal Disorders
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
title_full 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
title_fullStr 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
title_full_unstemmed 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
title_short 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
title_sort 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
url http://www.biomedcentral.com/1471-2474/12/274
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