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NCT Number: NCT01500044

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

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.

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Key information

Conditions

Radiculopathy Behavior Motor Activity Nervous System Diseases Neuromuscular Diseases Peripheral Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Centre for Interdisciplinary Research in Rehabilitation and Social Integration

Québec, Quebec, G1M 2S8, Canada

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Program targeting the opening of foramen

Procedure

Rehabilitation intervention that specifically targets the opening of the intervertebral foramen

Other names: Specific manual Therapy, Mobilization, Exercises

conventional rehabilitation program

Procedure

Program used in previous randomized clinical trials in this population

Other names: Non specific manual therapy, mobilization and exercises

Primary outcomes

  1. Change from baseline in the Neck Disability Index at 4 weeks

    Time frame: Week 4

Secondary outcomes

  1. Change from baseline in the Numerical Pain Rating Scale at 4 weeks

    Time frame: Week 4

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

    Time frame: Week 8

Sponsors and collaborators

Lead sponsor

Laval University

Other

Collaborators

  • Fonds de la Recherche en Santé du Québec

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Dec 26, 2011
Registry last updated
Jul 3, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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