<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03015493</url>
  </required_header>
  <id_info>
    <org_study_id>CHR7</org_study_id>
    <nct_id>NCT03015493</nct_id>
  </id_info>
  <brief_title>Effectiveness of Cervical Traction and Neural Mobilization in Patients With Cervical Radiculopathy</brief_title>
  <official_title>Cervical Traction Combined With Neural Mobilization for Patients With Cervical Radiculopathy: A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Christos Savva</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>European University Cyprus</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of the study is to examine the effects of cervical traction with or without the&#xD;
      addition of neural mobilization, in patients with cervical radiculopathy&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Background:Cervical radiculopathy (CR) is a disorder of the peripheral nervous system where&#xD;
      the resulted cervical nerve root (CNR) pathology produces a chronic pain and disability.&#xD;
      Based on some epidemiological findings, CR is a common clinical diagnosis since its annual&#xD;
      incidence has been estimated to be 83 cases per 100,000, with an increased prevalence noted&#xD;
      in the fifth decade of life. In addition, C6 and C7 nerve roots are most commonly involved in&#xD;
      this disorder, mainly due to the high range of motion occurring between cervical vertebrae&#xD;
      C5-C6 and C6-C7.&#xD;
&#xD;
      CR is caused by a disc herniation, or a space-occupying lesion that can result in CNR&#xD;
      inflammation, impingement, or both. In normal situations, CNRs ensure the normal function of&#xD;
      sensation, movement and motor coordination of the upper limb. Therefore, the development of&#xD;
      CR can produce sensory and motor deficits in the involved limb, including pins and needles,&#xD;
      numbness and muscle weakness, along with a neuropathic pain described as a burning or&#xD;
      shooting pain. These symptoms lead patients to exhibit severe functional limitations such as&#xD;
      difficulties to work, to sleep or to participate in hobbies. Studies on this topic identified&#xD;
      several socioeconomic and psychological deficits, from lost work and wages to prolonged pain&#xD;
      and impaired social functioning, leading patients with CR to express symptoms of anxiety and&#xD;
      depression.&#xD;
&#xD;
      Treatment of CR has been the subject of debate between physiotherapists and researchers.&#xD;
      Several non-operative treatment approaches have been advocated to reduce CR pain and their&#xD;
      analgesic effect has been recognized in a number of randomized clinical trials with these in&#xD;
      turn being analyzed in few systematic reviews. Based on these studies, patients with CR can&#xD;
      benefit from a multimodal treatment approach including the application of postural education,&#xD;
      cervical traction and manual therapy techniques (mobilization, thrust manipulation etc.)&#xD;
      applied to the cervical spine. However the small number of these studies as well as their&#xD;
      poor methodological quality due to the short-term follow ups, lack of patient's homogeneity,&#xD;
      randomization or control group etc., raise several questions about the validity of research&#xD;
      findings and therefore much more studies are necessary. Among manual therapy techniques that&#xD;
      have been recommended to improve the patient's pain and functional limitations, neural&#xD;
      mobilization (NM) has been advocated as an effective treatment option. NM introduced as an&#xD;
      intervention for pain relief more than 25 years ago are techniques that involve a specific&#xD;
      sequence of joint movements to mobilize the involved peripheral nerve in order to facilitate&#xD;
      the reduced nerve gliding and reduced the increased neural mechanosensitivity.&#xD;
&#xD;
      The application of NM is common but since now little research attention has been given to&#xD;
      support its usage in patients with CR. Recently, a case study and a randomized controlled&#xD;
      study concluded that neural mobilization applied simultaneously with cervical traction can&#xD;
      produce clinically meaningful improvements over a 4-week period, in terms of pain,&#xD;
      disability, function, grip strength and cervical spine range of motion. However, both&#xD;
      methodological designs did not allow determining whether NM provided these benefits. Thus,&#xD;
      the purpose of the present study was to examine the effects of cervical traction with or&#xD;
      without the addition of NM, in patients with CR.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date>May 2016</start_date>
  <completion_date type="Anticipated">February 2017</completion_date>
  <primary_completion_date type="Anticipated">February 2017</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Neck Disability Index</measure>
    <time_frame>Change from baseline after 4 weeks</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Numeric Pain Rating Scale</measure>
    <time_frame>Change from baseline after 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient-Specific Functional Scale</measure>
    <time_frame>Change from baseline after 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Grip strength measurement using a dynamometer</measure>
    <time_frame>Change from baseline after 4 weeks</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Measurement of cervical spine active range of motion using a universal goniometer</measure>
    <time_frame>Change from baseline after 4 weeks</time_frame>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">50</enrollment>
  <condition>Cervical Radiculopathy</condition>
  <arm_group>
    <arm_group_label>Neural mobilization and traction</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group are treated with neural mobilization techniques combined with cervical traction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Traction group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients in this group are treated with cervical traction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients in this group comprise the control group and are not treated with any intervention</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Neural mobilization combined with traction</intervention_name>
    <description>Neural mobilization techniques combined with cervical traction for the cervical nerve roots</description>
    <arm_group_label>Neural mobilization and traction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traction</intervention_name>
    <description>Traction techniques for the cervical spine</description>
    <arm_group_label>Traction group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Unilateral sensory and motor deficits including sharp pain, muscle weakness and&#xD;
             numbness in the upper arm&#xD;
&#xD;
          -  A positive result in a minimum three of four tests (Spurling's test, Distraction test,&#xD;
             Upper Limb Neurodynamic Test 1 and ipsilateral cervical rotation of less than 60) of a&#xD;
             clinical prediction rule. This clinical prediction rule has demonstrated 94%&#xD;
             specificity (95% = 0.88 to 1.00), 24% sensitivity (95% = 0.05 to 0.43) and a positive&#xD;
             likelihood ratio of 6.1 (95% = 2.0 to 18.6) when 3 of 4 items were positive&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  A current history of cervical myelopathy or signs of upper motor neuron disease&#xD;
&#xD;
          -  Bilateral CR or other musculoskeletal conditions in the affected limb.&#xD;
&#xD;
          -  Receive of any prescription or over-the-counter analgesia or anti-inflammatory&#xD;
             medication during the prior two weeks&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>22 Years</minimum_age>
    <maximum_age>71 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Chritos Savva, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>European University Cyprus</affiliation>
  </overall_official>
  <results_reference>
    <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.</citation>
    <PMID>19465371</PMID>
  </results_reference>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 6, 2017</study_first_submitted>
  <study_first_submitted_qc>January 9, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 10, 2017</study_first_posted>
  <last_update_submitted>January 13, 2017</last_update_submitted>
  <last_update_submitted_qc>January 13, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 16, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>European University Cyprus</investigator_affiliation>
    <investigator_full_name>Christos Savva</investigator_full_name>
    <investigator_title>Lecturer</investigator_title>
  </responsible_party>
  <keyword>Neck pain</keyword>
  <keyword>Neurodynamics</keyword>
  <keyword>Spinal manipulative therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Radiculopathy</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>Undecided</ipd_description>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03015493
org study id: CHR7
nct id: NCT03015493
lead sponsor: 
has dmc: No
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
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Neck Disability Index
time frame: Change from baseline after 4 weeks
measure: Numeric Pain Rating Scale
time frame: Change from baseline after 4 weeks
measure: Patient-Specific Functional Scale
time frame: Change from baseline after 4 weeks
measure: Grip strength measurement using a dynamometer
time frame: Change from baseline after 4 weeks
measure: Measurement of cervical spine active range of motion using a universal goniometer
time frame: Change from baseline after 4 weeks
arm group label: Neural mobilization and traction
arm group type: Experimental
description: Patients in this group are treated with neural mobilization techniques combined with cervical traction
arm group label: Traction group
arm group type: Experimental
description: Patients in this group are treated with cervical traction
arm group label: Control group
arm group type: No Intervention
description: Patients in this group comprise the control group and are not treated with any intervention
intervention type: Other
intervention name: Neural mobilization combined with traction
description: Neural mobilization techniques combined with cervical traction for the cervical nerve roots
arm group label: Neural mobilization and traction
intervention type: Other
intervention name: Traction
description: Traction techniques for the cervical spine
arm group label: Traction group
criteria: 
gender: All
minimum age: 22 Years
maximum age: 71 Years
healthy volunteers: No
last name: Chritos Savva, PhD
role: Principal Investigator
affiliation: European University Cyprus
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.
PMID: 19465371
responsible party type: Sponsor-Investigator
investigator affiliation: European University Cyprus
investigator full name: Christos Savva
investigator title: Lecturer
mesh term: Radiculopathy
sharing ipd: Undecided
ipd description: Undecided