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

Radiculopathy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01500044
• Other study ID #: 11-12-#09
• Status: Completed
• Phase: N/A
• First received: December 20, 2011
• Last updated: July 2, 2013
• Start date: January 2012
• Est. completion date: June 2013

Study information

• Verified date: July 2013
• Source: Laval University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 36
• Est. completion date: June 2013
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 65 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Radiculopathy

Intervention

Procedure:
• Program targeting the opening of foramen
Rehabilitation intervention that specifically targets the opening of the intervertebral foramen
• Conventional Rehabilitation Program
Program used in previous randomized clinical trials in this population

Locations

Country	Name	City	State
Canada	Centre for Interdisciplinary Research in Rehabilitation and Social Integration	Quebec City	Quebec

Sponsors (2)

Lead Sponsor	Collaborator
Laval University	Fonds de la Recherche en Santé du Québec

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in the Neck Disability Index at 4 weeks		Week 4	No
Secondary	Change from baseline in the Numerical Pain Rating Scale at 4 weeks		Week 4	No
Secondary	Change from baseline and week 4 in the Numerical Pain Rating Scale at 8 weeks		Week 8	No