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

Primary Purpose

Radiculopathy

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Program targeting the opening of foramen
Conventional Rehabilitation Program
Sponsored by
Laval University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Radiculopathy focused on measuring Radiculopathy, Rehabilitation, Mobilization, Exercise, Physical Therapy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Centre for Interdisciplinary Research in Rehabilitation and Social Integration

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional Rehabilitation Program

Program targeting the opening of foramen

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Change from baseline in the Neck Disability Index at 4 weeks

Secondary Outcome Measures

Change from baseline in the Numerical Pain Rating Scale at 4 weeks
Change from baseline and week 4 in the Numerical Pain Rating Scale at 8 weeks

Full Information

First Posted
December 20, 2011
Last Updated
July 2, 2013
Sponsor
Laval University
Collaborators
Fonds de la Recherche en Santé du Québec
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1. Study Identification

Unique Protocol Identification Number
NCT01500044
Brief Title
Effect of Mobilizations and Exercises Targeting the Opening of Intervertebral Foramens Following Cervical Radiculopathy
Official Title
Cervical Radiculopathy: A Randomized Clinical Trial Evaluating the Effect of Mobilizations and Exercises Targeting the Opening of Intervertebral Foramens
Study Type
Interventional

2. Study Status

Record Verification Date
July 2013
Overall Recruitment Status
Completed
Study Start Date
January 2012 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Laval University
Collaborators
Fonds de la Recherche en Santé du Québec

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Radiculopathy
Keywords
Radiculopathy, Rehabilitation, Mobilization, Exercise, Physical Therapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
36 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Conventional Rehabilitation Program
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Program targeting the opening of foramen
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Program targeting the opening of foramen
Other Intervention Name(s)
Specific manual Therapy, Mobilization, Exercises
Intervention Description
Rehabilitation intervention that specifically targets the opening of the intervertebral foramen
Intervention Type
Procedure
Intervention Name(s)
Conventional Rehabilitation Program
Other Intervention Name(s)
Non specific manual therapy, mobilization and exercises
Intervention Description
Program used in previous randomized clinical trials in this population
Primary Outcome Measure Information:
Title
Change from baseline in the Neck Disability Index at 4 weeks
Time Frame
Week 4
Secondary Outcome Measure Information:
Title
Change from baseline in the Numerical Pain Rating Scale at 4 weeks
Time Frame
Week 4
Title
Change from baseline and week 4 in the Numerical Pain Rating Scale at 8 weeks
Time Frame
Week 8

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Sebastien Roy, PT, PhD
Organizational Affiliation
Laval University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Centre for Interdisciplinary Research in Rehabilitation and Social Integration
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1M 2S8
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25420010
Citation
Langevin P, Desmeules F, Lamothe M, Robitaille S, Roy JS. Comparison of 2 manual therapy and exercise protocols for cervical radiculopathy: a randomized clinical trial evaluating short-term effects. J Orthop Sports Phys Ther. 2015 Jan;45(1):4-17. doi: 10.2519/jospt.2015.5211.
Results Reference
derived
PubMed Identifier
22293092
Citation
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. doi: 10.1186/1471-2474-13-10.
Results Reference
derived

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

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