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

NCT01500044 | Completed

• 1 other identifier: 11-12-#09
• Study Type: interventional
• Target: 36
• Locations: 1 country
• Sites: 1

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.

Conditions

Radiculopathy

Keywords

Radiculopathy; Rehabilitation; Mobilization; Exercise; Physical Therapy

Outcome Measures

Primary Outcomes (1)

• Change from baseline in the Neck Disability Index at 4 weeks

  Week 4

Secondary Outcomes (2)

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

  Week 4

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

  Week 8

Study Arms (2)

Conventional Rehabilitation Program

ACTIVE COMPARATOR

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 targeting the opening of foramen

EXPERIMENTAL

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

Interventions

Program targeting the opening of foramen PROCEDURE

Rehabilitation intervention that specifically targets the opening of the intervertebral foramen

Also known as: Specific manual Therapy, Mobilization, Exercises

Program targeting the opening of foramen

Conventional Rehabilitation Program PROCEDURE

Program used in previous randomized clinical trials in this population

Also known as: Non specific manual therapy, mobilization and exercises

Conventional Rehabilitation Program

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Laval University: lead
• Fonds de la Recherche en Santé du Québec: collaborator

Study Sites (1)

Centre for Interdisciplinary Research in Rehabilitation and Social Integration

Québec, Quebec, G1M 2S8, Canada

Location

Related Publications (2)

• 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.

  PMID: 25420010 DERIVED

• 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.

  PMID: 22293092 DERIVED

MeSH Terms

Conditions

Radiculopathy; Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Peripheral Nervous System Diseases; Neuromuscular Diseases; Nervous System Diseases; Behavior

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Jean-Sebastien Roy, PT, PhD

  Laval University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 20, 2011
• First Posted: December 26, 2011
• Study Start: January 1, 2012
• Primary Completion: June 1, 2013
• Study Completion: June 1, 2013
• Last Updated: July 3, 2013

Record last verified: 2013-07

Locations

CA (1)