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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Cervical Radiculopathy: A Randomized Clinical Trial Evaluating the Effect of Mobilizations and Exercises Targeting the Opening of Intervertebral Foramens

Brief Summary:

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.


Detailed Summary:

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).


Sponsor: Laval University

Current Primary Outcome: Change from baseline in the Neck Disability Index at 4 weeks [ Time Frame: Week 4 ]

Original Primary Outcome:

  • Baseline self-reported neck pain related disability measured with the "Neck Disability Index" [ Time Frame: Week 0 ]
    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 ]
  • Change from Baseline and week 4 in the Neck Disability Index at 8 weeks [ Time Frame: Week 8 ]


Current Secondary Outcome:

  • Change from baseline in the Numerical Pain Rating Scale at 4 weeks [ Time Frame: Week 4 ]
  • Change from baseline and week 4 in the Numerical Pain Rating Scale at 8 weeks [ Time Frame: Week 8 ]


Original Secondary Outcome:

  • Baseline self-reported neck pain measured with a "Numerical Pain Rating Scale" [ Time Frame: Week 0 ]
    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 ]
  • Change from baseline and week 4 in the Numerical Pain Rating Scale at 8 weeks [ Time Frame: Week 8 ]


Information By: Laval University

Dates:
Date Received: December 20, 2011
Date Started: January 2012
Date Completion:
Last Updated: July 2, 2013
Last Verified: July 2013