Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effectiveness of Cervical Traction and Neural Mobilization in Patients With Cervical Radiculopathy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03015493
Recruitment Status : Unknown
Verified January 2017 by Christos Savva, European University Cyprus.
Recruitment status was:  Active, not recruiting
First Posted : January 10, 2017
Last Update Posted : January 16, 2017
Sponsor:
Information provided by (Responsible Party):
Christos Savva, European University Cyprus

Brief Summary:
The purpose of the study is to examine the effects of cervical traction with or without the addition of neural mobilization, in patients with cervical radiculopathy

Condition or disease Intervention/treatment Phase
Cervical Radiculopathy Other: Neural mobilization combined with traction Other: Traction Not Applicable

Detailed Description:

Background:Cervical radiculopathy (CR) is a disorder of the peripheral nervous system where the resulted cervical nerve root (CNR) pathology produces a chronic pain and disability. Based on some epidemiological findings, CR is a common clinical diagnosis since its annual incidence has been estimated to be 83 cases per 100,000, with an increased prevalence noted in the fifth decade of life. In addition, C6 and C7 nerve roots are most commonly involved in this disorder, mainly due to the high range of motion occurring between cervical vertebrae C5-C6 and C6-C7.

CR is caused by a disc herniation, or a space-occupying lesion that can result in CNR inflammation, impingement, or both. In normal situations, CNRs ensure the normal function of sensation, movement and motor coordination of the upper limb. Therefore, the development of CR can produce sensory and motor deficits in the involved limb, including pins and needles, numbness and muscle weakness, along with a neuropathic pain described as a burning or shooting pain. These symptoms lead patients to exhibit severe functional limitations such as difficulties to work, to sleep or to participate in hobbies. Studies on this topic identified several socioeconomic and psychological deficits, from lost work and wages to prolonged pain and impaired social functioning, leading patients with CR to express symptoms of anxiety and depression.

Treatment of CR has been the subject of debate between physiotherapists and researchers. Several non-operative treatment approaches have been advocated to reduce CR pain and their analgesic effect has been recognized in a number of randomized clinical trials with these in turn being analyzed in few systematic reviews. Based on these studies, patients with CR can benefit from a multimodal treatment approach including the application of postural education, cervical traction and manual therapy techniques (mobilization, thrust manipulation etc.) applied to the cervical spine. However the small number of these studies as well as their poor methodological quality due to the short-term follow ups, lack of patient's homogeneity, randomization or control group etc., raise several questions about the validity of research findings and therefore much more studies are necessary. Among manual therapy techniques that have been recommended to improve the patient's pain and functional limitations, neural mobilization (NM) has been advocated as an effective treatment option. NM introduced as an intervention for pain relief more than 25 years ago are techniques that involve a specific sequence of joint movements to mobilize the involved peripheral nerve in order to facilitate the reduced nerve gliding and reduced the increased neural mechanosensitivity.

The application of NM is common but since now little research attention has been given to support its usage in patients with CR. Recently, a case study and a randomized controlled study concluded that neural mobilization applied simultaneously with cervical traction can produce clinically meaningful improvements over a 4-week period, in terms of pain, disability, function, grip strength and cervical spine range of motion. However, both methodological designs did not allow determining whether NM provided these benefits. Thus, the purpose of the present study was to examine the effects of cervical traction with or without the addition of NM, in patients with CR.


Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Cervical Traction Combined With Neural Mobilization for Patients With Cervical Radiculopathy: A Randomized Controlled Trial.
Study Start Date : May 2016
Estimated Primary Completion Date : February 2017
Estimated Study Completion Date : February 2017

Arm Intervention/treatment
Experimental: Neural mobilization and traction
Patients in this group are treated with neural mobilization techniques combined with cervical traction
Other: Neural mobilization combined with traction
Neural mobilization techniques combined with cervical traction for the cervical nerve roots

Experimental: Traction group
Patients in this group are treated with cervical traction
Other: Traction
Traction techniques for the cervical spine

No Intervention: Control group
Patients in this group comprise the control group and are not treated with any intervention



Primary Outcome Measures :
  1. Neck Disability Index [ Time Frame: Change from baseline after 4 weeks ]

Secondary Outcome Measures :
  1. Numeric Pain Rating Scale [ Time Frame: Change from baseline after 4 weeks ]
  2. Patient-Specific Functional Scale [ Time Frame: Change from baseline after 4 weeks ]
  3. Grip strength measurement using a dynamometer [ Time Frame: Change from baseline after 4 weeks ]
  4. Measurement of cervical spine active range of motion using a universal goniometer [ Time Frame: Change from baseline after 4 weeks ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   22 Years to 71 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Unilateral sensory and motor deficits including sharp pain, muscle weakness and numbness in the upper arm
  • A positive result in a minimum three of four tests (Spurling's test, Distraction test, Upper Limb Neurodynamic Test 1 and ipsilateral cervical rotation of less than 60) of a clinical prediction rule. This clinical prediction rule has demonstrated 94% specificity (95% = 0.88 to 1.00), 24% sensitivity (95% = 0.05 to 0.43) and a positive likelihood ratio of 6.1 (95% = 2.0 to 18.6) when 3 of 4 items were positive

Exclusion Criteria:

  • A current history of cervical myelopathy or signs of upper motor neuron disease
  • Bilateral CR or other musculoskeletal conditions in the affected limb.
  • Receive of any prescription or over-the-counter analgesia or anti-inflammatory medication during the prior two weeks

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03015493


Sponsors and Collaborators
Christos Savva
Investigators
Layout table for investigator information
Principal Investigator: Chritos Savva, PhD European University Cyprus

Publications of Results:
Layout table for additonal information
Responsible Party: Christos Savva, Lecturer, European University Cyprus
ClinicalTrials.gov Identifier: NCT03015493     History of Changes
Other Study ID Numbers: CHR7
First Posted: January 10, 2017    Key Record Dates
Last Update Posted: January 16, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Undecided

Keywords provided by Christos Savva, European University Cyprus:
Neck pain
Neurodynamics
Spinal manipulative therapy

Additional relevant MeSH terms:
Layout table for MeSH terms
Radiculopathy
Peripheral Nervous System Diseases
Neuromuscular Diseases
Nervous System Diseases