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Open Access Highly Accessed Study protocol

Cervical radiculopathy: Study protocol of a randomised clinical trial evaluating the effect of mobilisations and exercises targeting the opening of intervertebral foramen [NCT01500044]

Pierre Langevin12*, Jean-Sébastien Roy23 and François Desmeules45

Author Affiliations

1 Physio interactive Clinics, 3520, rue de l'Hêtrière, Saint-Augustin-de-Desmaures, (QC), Canada, G3A 0B4

2 Department of Rehabilitation, Faculty of Medicine, Laval University, Pavillon Ferdinand-Vandry, 1050, avenue de la Médecine, Quebec City (QC), Canada, G1R 1P5

3 Centre for Interdisciplinary Research in Rehabilitation and Social Integration, Quebec Rehabilitation Institute, 525, Boulevard Wilfrid Hamel, Quebec City (QC), Canada, G1M 2S8

4 School of Rehabilitation, University of Montreal, CP 6128 Succursale Centre-Ville, Montreal (QC), Canada, H3C 3J7

5 Orthopaedic Clinical Research Unit, Maisonneuve-Rosemont Hospital Research Center, 5415, Boulevard l'Assomption, Montreal (QC), Canada, H1T 2M4

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BMC Musculoskeletal Disorders 2012, 13:10  doi:10.1186/1471-2474-13-10

Published: 31 January 2012

Abstract

Background

Cervical radiculopathy is a common form of neck pain and has been shown to lead to severe disability. Clinical rehabilitation approaches for cervical radiculopathies commonly include exercise and manual therapy interventions targeting the opening of intervertebral foramen, but evidence regarding their effectiveness is scarce. The primary objective of this randomised clinical trial is to compare, in terms of pain and disability, a rehabilitation program targeting the opening of intervertebral foramen to a conventional rehabilitation program, for patients presenting acute or subacute cervical radiculopathies. The hypothesis is that the rehabilitation program targeting the opening of intervertebral foramen will be significantly more effective in reducing pain and disability than the conventional rehabilitation program.

Methods/Design

This study is a double-blind (participants and evaluators blinded) randomised clinical trial that will allow the comparison of patients with a cervical radiculopathy randomly assigned to one of two groups: one group will receive a 4-week rehabilitation program targeting the opening of intervertebral foramen, and the second group will receive a 4-week conventional rehabilitation program. Thirty-six subjects with cervical radiculopathy will be recruited from participating medical and physiotherapy clinics and will be evaluated at baseline, at the end of the 4-week program and four weeks following the end of the program. The primary outcome measure will be the validated Neck Disability Index questionnaire. Secondary outcome measures will include the short version of the Disabilities of the Arm, Shoulder and Hand questionnaire, a numerical pain rating scale, cervicothoracic mobility and patients' perceived global rating of change. During the 4-week rehabilitation program, each participant will take part in eight physiotherapy treatment sessions (2 session/week) and will perform a home exercise program. A mixed-model, 2-way ANOVA will be used to analyze the effects of the rehabilitation programs.

Discussion

Control trials are needed to define ideal intervention approaches in rehabilitation for this population. This randomised clinical trial will be the first study that directly compares a rehabilitation program targeting the opening of intervertebral foramen to a conventional rehabilitation program for patients with cervical radiculopathy. The results of this study may help to establish best clinical practice guidelines for this patient population.

Trial Registration

ClinicalTrials.gov: NCT01500044

Keywords:
Cervical; Radiculopathy; Neck pain; Exercises; Mobilisations; Intervertebral foramen