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Effect of Mobilizations and Exercises Targeting the Opening of Intervertebral Foramens Following Cervical Radiculopathy

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Fonds de la Recherche en Santé du Québec
Information provided by (Responsible Party):
Jean-Sébastien Roy, Laval University
ClinicalTrials.gov Identifier:
NCT01500044
First received: December 20, 2011
Last updated: June 26, 2012
Last verified: June 2012
History of Changes
  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:

U.S. FDA Resources

Further study details as provided by Laval University:

Primary Outcome Measures:
  • Change from baseline in the Neck Disability Index at 4 weeks [ Time Frame: Week 4 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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
Other Name: Non specific manual therapy, mobilization and exercises
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
Other Name: Specific manual Therapy, Mobilization, Exercises

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

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):

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: June 26, 2012
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 22, 2013