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

Primary Purpose

Cervical Radiculopathy

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Neural mobilization combined with traction
Traction
Sponsored by
Christos Savva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cervical Radiculopathy focused on measuring Neck pain, Neurodynamics, Spinal manipulative therapy

Eligibility Criteria

22 Years - 71 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm Type

    Experimental

    Experimental

    No Intervention

    Arm Label

    Neural mobilization and traction

    Traction group

    Control group

    Arm Description

    Patients in this group are treated with neural mobilization techniques combined with cervical traction

    Patients in this group are treated with cervical traction

    Patients in this group comprise the control group and are not treated with any intervention

    Outcomes

    Primary Outcome Measures

    Neck Disability Index

    Secondary Outcome Measures

    Numeric Pain Rating Scale
    Patient-Specific Functional Scale
    Grip strength measurement using a dynamometer
    Measurement of cervical spine active range of motion using a universal goniometer

    Full Information

    First Posted
    January 6, 2017
    Last Updated
    January 13, 2017
    Sponsor
    Christos Savva
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03015493
    Brief Title
    Effectiveness of Cervical Traction and Neural Mobilization in Patients With Cervical Radiculopathy
    Official Title
    Cervical Traction Combined With Neural Mobilization for Patients With Cervical Radiculopathy: A Randomized Controlled Trial.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    May 2016 (undefined)
    Primary Completion Date
    February 2017 (Anticipated)
    Study Completion Date
    February 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Christos Savva

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    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
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Cervical Radiculopathy
    Keywords
    Neck pain, Neurodynamics, Spinal manipulative therapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    InvestigatorOutcomes Assessor
    Allocation
    Randomized
    Enrollment
    50 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Neural mobilization and traction
    Arm Type
    Experimental
    Arm Description
    Patients in this group are treated with neural mobilization techniques combined with cervical traction
    Arm Title
    Traction group
    Arm Type
    Experimental
    Arm Description
    Patients in this group are treated with cervical traction
    Arm Title
    Control group
    Arm Type
    No Intervention
    Arm Description
    Patients in this group comprise the control group and are not treated with any intervention
    Intervention Type
    Other
    Intervention Name(s)
    Neural mobilization combined with traction
    Intervention Description
    Neural mobilization techniques combined with cervical traction for the cervical nerve roots
    Intervention Type
    Other
    Intervention Name(s)
    Traction
    Intervention Description
    Traction techniques for the cervical spine
    Primary Outcome Measure Information:
    Title
    Neck Disability Index
    Time Frame
    Change from baseline after 4 weeks
    Secondary Outcome Measure Information:
    Title
    Numeric Pain Rating Scale
    Time Frame
    Change from baseline after 4 weeks
    Title
    Patient-Specific Functional Scale
    Time Frame
    Change from baseline after 4 weeks
    Title
    Grip strength measurement using a dynamometer
    Time Frame
    Change from baseline after 4 weeks
    Title
    Measurement of cervical spine active range of motion using a universal goniometer
    Time Frame
    Change from baseline after 4 weeks

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    22 Years
    Maximum Age & Unit of Time
    71 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Chritos Savva, PhD
    Organizational Affiliation
    European University Cyprus
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    Undecided
    IPD Sharing Plan Description
    Undecided
    Citations:
    PubMed Identifier
    19465371
    Citation
    Young IA, Michener LA, Cleland JA, Aguilera AJ, Snyder AR. Manual therapy, exercise, and traction for patients with cervical radiculopathy: a randomized clinical trial. Phys Ther. 2009 Jul;89(7):632-42. doi: 10.2522/ptj.20080283. Epub 2009 May 21. Erratum In: Phys Ther. 2009 Nov;89(11):1254-5. Phys Ther. 2010 May;90(5):825.
    Results Reference
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    Effectiveness of Cervical Traction and Neural Mobilization in Patients With Cervical Radiculopathy

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