Effect of Mobilizations and Exercises Targeting the Opening of Intervertebral Foramens Following Cervical Radiculopathy
|ClinicalTrials.gov Identifier: NCT01500044|
Recruitment Status : Completed
First Posted : December 26, 2011
Last Update Posted : July 3, 2013
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 or disease||Intervention/treatment||Phase|
|Radiculopathy||Procedure: Program targeting the opening of foramen Procedure: Conventional Rehabilitation Program||Not Applicable|
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).
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||36 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Investigator, Outcomes Assessor)|
|Official Title:||Cervical Radiculopathy: A Randomized Clinical Trial Evaluating the Effect of Mobilizations and Exercises Targeting the Opening of Intervertebral Foramens|
|Study Start Date :||January 2012|
|Actual Primary Completion Date :||June 2013|
|Actual Study Completion Date :||June 2013|
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 foramen
Rehabilitation intervention that specifically targets the opening of the intervertebral foramen
Other Name: Specific manual Therapy, Mobilization, Exercises
- Change from baseline in the Neck Disability Index at 4 weeks [ Time Frame: Week 4 ]
- 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 ]
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01500044
|Centre for Interdisciplinary Research in Rehabilitation and Social Integration|
|Quebec City, Quebec, Canada, G1M 2S8|
|Principal Investigator:||Jean-Sebastien Roy, PT, PhD||Laval University|