Effect of Mobilizations and Exercises Targeting the Opening of Intervertebral Foramens Following Cervical Radiculopathy - Full Text View

Sponsor:	Laval University
Collaborator:	Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):	Jean-Sébastien Roy, Laval University
ClinicalTrials.gov Identifier:	NCT01500044

Purpose

The primary objective of this randomised clinical trial (RCT) is to compare, in terms of disability and pain, an intervention targeting the opening of intervertebral foramens to a conventional physiotherapy intervention, in patients presenting acute or subacute cervical radiculopathies. Based on biomechanical principles, the investigators hypothesis is that the intervention targeting the opening of intervertebral foramens will be significantly more effective in reducing pain and disability than the conventional physiotherapy intervention.

This study is double-blind RCT 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 will be recruited from participating medical and physiotherapy clinics in the Quebec City area (Canada) and will be evaluated at baseline, at the end of the program and four weeks following the end of the program. The primary outcome measure will be the validated Neck Disability Index (NDI) questionnaire and other secondary measures will include the QuickDASH questionnaire, a numerical pain rating scale, cervicothoracic mobility and patients' perceived global rating of change.

Condition	Intervention
Radiculopathy	Procedure: Program targeting the opening of intervertebral foramen Procedure: Conventional Rehabilitation Program

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator, Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Cervical Radiculopathy: A Randomized Clinical Trial Evaluating the Effect of Mobilizations and Exercises Targeting the Opening of Intervertebral Foramens

Resource links provided by NLM:

MedlinePlus related topics: Exercise and Physical Fitness Neck Injuries and Disorders Rehabilitation

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:

Baseline self-reported neck pain related disability measured with the "Neck Disability Index" [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
The Neck Disability Index is a 10-item questionnaire that measures a patient's self-reported neck pain related disability. Questions include activities of daily living, such as: personal care, lifting, reading, work, driving, sleeping, recreational activities, pain intensity, concentration and headache.
Change from baseline in the Neck Disability Index at 4 weeks [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Change from Baseline and week 4 in the Neck Disability Index at 8 weeks [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Baseline self-reported neck pain measured with a "Numerical Pain Rating Scale" [ Time Frame: Week 0 ] [ Designated as safety issue: No ]
The level of upper limb and neck pain will be captured separately with the NPRS. Using an 11-point scale, ranging from 0 (no pain) to 10 (worst pain imaginable), participants will be asked to answer the following question: "On a scale of 0 to 10, where 0 corresponds to no pain and 10 to the worst imaginable pain, evaluate the intensity of your neck pain at this moment".
Change from baseline in the Numerical Pain Rating Scale at 4 weeks [ Time Frame: Week 4 ] [ Designated as safety issue: No ]
Change from baseline and week 4 in the Numerical Pain Rating Scale at 8 weeks [ Time Frame: Week 8 ] [ Designated as safety issue: No ]

Estimated Enrollment:	36
Study Start Date:	January 2012
Estimated Study Completion Date:	June 2013
Estimated Primary Completion Date:	December 2012 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: Conventional Rehabilitation Program The conventional program consists in cervicothoracic mobilizations and stabilization exercises. This program is based on the intervention used in clinical practice, and on programs proposed in two RCTs evaluating individuals with neck and arm pain that do not include any specific mobilization or exercise leading to the opening of the intervertebral foramen. Four mobilisation techniques will be executed at each treatment session. However, the therapists will not be allowed to use techniques that specifically open the intervertebral foramen of the affected segment, two segments above and two segments below.	Procedure: Conventional Rehabilitation Program Program used in previous randomized clinical trials in this population
Experimental: Program targeting the opening of foramen The same interventions as for the conventional rehabilitation program will be applied, except: Of the four mobilisation techniques, there will be two mandatory techniques targeting the opening of the intervertebral foramen on the same side and at the same level as the radiculopathy: global contralateral rotation mobilisation and ipsilateral lateral shearing in a flexion position. The therapist, according to the biomechanical evaluation results, will choose the two other mobilisation techniques.	Procedure: Program targeting the opening of intervertebral foramen Rehabilitation intervention that specifically targets the opening of the intervertebral foramen

Arms

Assigned Interventions

Active Comparator: Conventional Rehabilitation Program

The conventional program consists in cervicothoracic mobilizations and stabilization exercises. This program is based on the intervention used in clinical practice, and on programs proposed in two RCTs evaluating individuals with neck and arm pain that do not include any specific mobilization or exercise leading to the opening of the intervertebral foramen. Four mobilisation techniques will be executed at each treatment session. However, the therapists will not be allowed to use techniques that specifically open the intervertebral foramen of the affected segment, two segments above and two segments below.

Procedure: Conventional Rehabilitation Program

Program used in previous randomized clinical trials in this population

Experimental: Program targeting the opening of foramen

The same interventions as for the conventional rehabilitation program will be applied, except:

Of the four mobilisation techniques, there will be two mandatory techniques targeting the opening of the intervertebral foramen on the same side and at the same level as the radiculopathy: global contralateral rotation mobilisation and ipsilateral lateral shearing in a flexion position. The therapist, according to the biomechanical evaluation results, will choose the two other mobilisation techniques.

Procedure: Program targeting the opening of intervertebral foramen

Rehabilitation intervention that specifically targets the opening of the intervertebral foramen

Detailed Description:

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.

This double-blind randomised clinical trial will allow the comparison, in terms of pain and disability, of patients presenting a cervical radiculopathy which will have been randomly assigned to one of the two intervention groups: the first group (n = 18) will receive a 4-week rehabilitation program targeting the opening of intervertebral foramen, the second group (n = 18) will receive a 4-week conventional rehabilitation program. Participants will be evaluated on three separate occasions: at baseline (week 0), at the end of the 4-week program (week 4), and four weeks following the end of the program (week 8).

Eligibility

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

pain, paresthesia or numbness in the upper-limb with cervical or periscapular pain for less than 3 months
at least one neurological sign (dermatomes, myotomes or reflexes) of an inferior motoneuron lesion to the upper-limb
positive responses to at least 3 of the 4 following clinical tests: Spurling Test, Upper Limb Tension Test, Cervical Distraction Test, and less than 60o of cervical rotation on the impaired side

Exclusion Criteria:

prior surgery to the cervicothoracic spine
bilateral upper-limb symptoms
signs of superior motoneuron impairments (bilateral paresthesia, hyperreflexia, spasticity)
cervical spine infiltration in the previous four weeks
current use of steroidal anti-inflammatory drugs

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01500044

Contacts

Contact: Pierre Langevin, PT, MClSc

418-656-2131 ext 7320

Pierre.Langevin@fmed.ulaval.ca

Locations

Canada, Quebec
Centre for Interdisciplinary Research in Rehabilitation and Social Integration
Quebec City, Quebec, Canada, G1M 2S8

Sponsors and Collaborators

Laval University

Fonds de la Recherche en Santé du Québec

Investigators

Principal Investigator:

Jean-Sebastien Roy, PT, PhD

Laval University

More Information

No publications provided by Laval University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Langevin P, Roy JS, Desmeules F. Cervical radiculopathy: Study protocol of a randomised clinical trial evaluating the effect of mobilisations and exercises targeting the opening of intervertebral foramen [NCT01500044]. BMC Musculoskelet Disord. 2012 Jan 31;13:10.

Responsible Party:	Jean-Sébastien Roy, Principal Investigator, Laval University
ClinicalTrials.gov Identifier:	NCT01500044 History of Changes
Other Study ID Numbers:	11-12-#09
Study First Received:	December 20, 2011
Last Updated:	December 21, 2011
Health Authority:	Canada: Ethics Review Committee

Keywords provided by Laval University:

Radiculopathy
Rehabilitation
Mobilization
Exercise
Physical Therapy

Additional relevant MeSH terms:

Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases

ClinicalTrials.gov processed this record on May 23, 2012