<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/NCT04406753</url>
  </required_header>
  <id_info>
    <org_study_id>N13/2020</org_study_id>
    <nct_id>NCT04406753</nct_id>
  </id_info>
  <brief_title>Indirect Approach of C0-1 and C2-3 Segments in Flexion-rotation Test</brief_title>
  <official_title>Is it Possible to Improve the Flexion-rotation Test With an Indirect Approach of C0-1 and C2-3 Segments? A Randomized Controlled Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidad de Zaragoza</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidad de Zaragoza</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Restrictions on upper cervical spine are associated with cervical pain. The vast majority of&#xD;
      upper cervical spine rotation occurs at the C1-2 segment. Flexion-rotation test is a valid&#xD;
      measure that predominantly measures rotation in C1-2 segment, however upper cervical spine&#xD;
      rotation also implies C0-1 and C2-3 due to ligament anatomy. Restriction in flexion-rotation&#xD;
      may be due to direct restriction in C1-2, but also to a premature tightening of the alar&#xD;
      ligament as a result of lack of movement in C0-1 or C2-3.&#xD;
&#xD;
      The objective is to compare the effect of a 20-minutes single cervical exercise session with&#xD;
      or without manual therapy of C0-1 and C2-3 segment in flexion-rotation test in patients with&#xD;
      chronic neck pain and positive flexion-rotation test.&#xD;
&#xD;
      To carry out the objective, the following will be designed a randomized controlled&#xD;
      assessor-blind clinical trial with primary healthcare patients.&#xD;
&#xD;
      This population will be patients with chronic neck pain and positive flexion-rotation test.&#xD;
      These patients will be assigned in manual therapy + exercise group or in exercise group.&#xD;
&#xD;
      Exercise will be focused on deep anterior cervical muscles. Manual therapy will combine&#xD;
      techniques in C0-1 and C2-3 with this exercise. Flexion-rotation test, neck pain intensity,&#xD;
      pain intensity during the flexion-rotation test and cervical range of motion will be measured&#xD;
      before and after the intervention.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Anticipated">June 1, 2020</start_date>
  <completion_date type="Anticipated">July 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">July 1, 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Flexion-rotation test</measure>
    <time_frame>Change between baseline(immediately before intervention) and post intervention (immediately after intervention)</time_frame>
    <description>This test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 33º</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neck pain intensity with Numeric Pain Rating Scale</measure>
    <time_frame>Change between baseline(immediately before intervention) and post intervention (immediately after intervention)</time_frame>
    <description>The Numeric Pain Rating Scale (NPRS) is a one-dimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain intensity during the flexion-rotation test with Numeric Pain Rating Scale</measure>
    <time_frame>Change between baseline(immediately before intervention) and post intervention (immediately after intervention)</time_frame>
    <description>It will be recorded if the patient has pain during the flexion-rotation test</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Cervical range of motion</measure>
    <time_frame>Change between baseline(immediately before intervention) and post intervention (immediately after intervention)</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">48</enrollment>
  <condition>Neck Pain</condition>
  <condition>Cervical Spine Disease</condition>
  <condition>Rotation</condition>
  <arm_group>
    <arm_group_label>Manual Therapy + Exercise Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Manual Therapy + Exercise group will carry out 20-minute session of treatment. The techniques will be applied depending on the clinical findings in each patient and the objective will be to restore the function of C0-1 and C2-3 segments before applying cervical exercises. We will use manipulation (high velocity low amplitude) and/or mobilization (low velocity high amplitude) techniques of C0-1 and C2-3 segments with cervical exercise. Manipulations will be in the direction of traction, with the head in a neutral position. A maximum of two trials at each level on each side will perform (2-6 thrusts). Mobilization will be performed for 5 minutes using repeating cycles of 45 seconds of mobilization and 15 seconds of rest. The cervical exercise will perform by this group will follow the same methodology as the Exercise group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Exercise Group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>This group will perform the cervical stabilization exercise. They will be teach to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine. Exercise will be always carry out without pain, because pain can be an inhibitor of muscle contraction.&#xD;
The Exercise group will carry out one 20-minute session, composed of 2 sets of 10 repetitions, holding each repetition for 10 seconds, a 40-second rest between each repetition and 2 minutes between sets.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Manual therapy techniques in C0-1 and C2-3 with cervical exercise</intervention_name>
    <description>Manual Therapy + Exercise group will carry out 20-minute session of treatment. The techniques will be applied depending on the clinical findings in each patient and the objective will be to restore the function of C0-1 and C2-3 segments before applying cervical exercises. We will use manipulation (high velocity low amplitude) and/or mobilization (low velocity high amplitude) techniques of C0-1 and C2-3 segments with cervical exercise. Manipulations will be in the direction of traction, with the head in a neutral position. A maximum of two trials at each level on each side will perform (2-6 thrusts). Mobilization will be performed for 5 minutes using repeating cycles of 45 seconds of mobilization and 15 seconds of rest. The cervical exercise will perform by this group will follow the same methodology as the Exercise group.</description>
    <arm_group_label>Manual Therapy + Exercise Group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cervical Exercise</intervention_name>
    <description>This group will perform the cervical stabilization exercise. They will be teach to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine. Exercise will be always carry out without pain, because pain can be an inhibitor of muscle contraction.&#xD;
The Exercise group will carry out one 20-minute session, composed of 2 sets of 10 repetitions, holding each repetition for 10 seconds, a 40-second rest between each repetition and 2 minutes between sets.</description>
    <arm_group_label>Exercise Group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  A medical diagnosis of chronic neck pain with more than 3 months of evolution.&#xD;
&#xD;
          -  A positive result in the flexion-rotation test (less than 33º or a difference of 10º&#xD;
             or more between the two rotations).&#xD;
&#xD;
          -  Being over 18 years old.&#xD;
&#xD;
          -  Having signed the informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Contraindications for manual therapy or exercise.&#xD;
&#xD;
          -  Having participated in exercise or manual therapy programs in the last three months.&#xD;
&#xD;
          -  Presenting warning signs or having suffered a relevant neck trauma.&#xD;
&#xD;
          -  An inability to maintain supine position.&#xD;
&#xD;
          -  The use of pacemakers (the magnets in the CROM device could alter their signal)&#xD;
&#xD;
          -  An inability to perform flexion-rotation test&#xD;
&#xD;
          -  Language difficulties.&#xD;
&#xD;
          -  Pending litigation or lawsuits.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jacobo Rodríguez-Sanz, PhD</last_name>
    <phone>+34636136789</phone>
    <email>jacobors@unizar.es</email>
  </overall_contact>
  <location>
    <facility>
      <name>Universidad de Zaragoza</name>
      <address>
        <city>Zaragoza</city>
        <zip>50009</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Jacobo Rodríguez-Sanz, PhD</last_name>
      <phone>+34636136789</phone>
      <email>jacobors@unizar.es</email>
    </contact>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>May 20, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 28, 2020</study_first_posted>
  <last_update_submitted>May 22, 2020</last_update_submitted>
  <last_update_submitted_qc>May 22, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidad de Zaragoza</investigator_affiliation>
    <investigator_full_name>Jacobo Rodríguez-Sanz</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>manual therapy</keyword>
  <keyword>neck pain</keyword>
  <keyword>exercise</keyword>
  <keyword>restriction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spinal Diseases</mesh_term>
    <mesh_term>Neck Pain</mesh_term>
  </condition_browse>
  <!-- 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/NCT04406753
org study id: N13/2020
nct id: NCT04406753
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Restrictions on upper cervical spine are associated with cervical pain. The vast majority of
      upper cervical spine rotation occurs at the C1-2 segment. Flexion-rotation test is a valid
      measure that predominantly measures rotation in C1-2 segment, however upper cervical spine
      rotation also implies C0-1 and C2-3 due to ligament anatomy. Restriction in flexion-rotation
      may be due to direct restriction in C1-2, but also to a premature tightening of the alar
      ligament as a result of lack of movement in C0-1 or C2-3.

      The objective is to compare the effect of a 20-minutes single cervical exercise session with
      or without manual therapy of C0-1 and C2-3 segment in flexion-rotation test in patients with
      chronic neck pain and positive flexion-rotation test.

      To carry out the objective, the following will be designed a randomized controlled
      assessor-blind clinical trial with primary healthcare patients.

      This population will be patients with chronic neck pain and positive flexion-rotation test.
      These patients will be assigned in manual therapy + exercise group or in exercise group.

      Exercise will be focused on deep anterior cervical muscles. Manual therapy will combine
      techniques in C0-1 and C2-3 with this exercise. Flexion-rotation test, neck pain intensity,
      pain intensity during the flexion-rotation test and cervical range of motion will be measured
      before and after the intervention.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Flexion-rotation test
time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
description: This test is used to see the amount of movement of the upper cervical spine and is the test most used in the literature. It is positive when there is a decrease of 10 degrees or more in the cervical rotation with maximum flexion, in a sense with respect to the contralateral or presents hypomobility of segment C1 with a mobility less than 33º
measure: Neck pain intensity with Numeric Pain Rating Scale
time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
description: The Numeric Pain Rating Scale (NPRS) is a one-dimensional measure of pain intensity in adults. The NPRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The common format is a horizontal bar or line. Similar to the VAS, the NPRS is anchored by terms describing pain severity extremes.
measure: Pain intensity during the flexion-rotation test with Numeric Pain Rating Scale
time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
description: It will be recorded if the patient has pain during the flexion-rotation test
measure: Cervical range of motion
time frame: Change between baseline(immediately before intervention) and post intervention (immediately after intervention)
arm group label: Manual Therapy + Exercise Group
arm group type: Experimental
description: Manual Therapy + Exercise group will carry out 20-minute session of treatment. The techniques will be applied depending on the clinical findings in each patient and the objective will be to restore the function of C0-1 and C2-3 segments before applying cervical exercises. We will use manipulation (high velocity low amplitude) and/or mobilization (low velocity high amplitude) techniques of C0-1 and C2-3 segments with cervical exercise. Manipulations will be in the direction of traction, with the head in a neutral position. A maximum of two trials at each level on each side will perform (2-6 thrusts). Mobilization will be performed for 5 minutes using repeating cycles of 45 seconds of mobilization and 15 seconds of rest. The cervical exercise will perform by this group will follow the same methodology as the Exercise group.
arm group label: Exercise Group
arm group type: Active Comparator
description: This group will perform the cervical stabilization exercise. They will be teach to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine. Exercise will be always carry out without pain, because pain can be an inhibitor of muscle contraction.
The Exercise group will carry out one 20-minute session, composed of 2 sets of 10 repetitions, holding each repetition for 10 seconds, a 40-second rest between each repetition and 2 minutes between sets.
intervention type: Other
intervention name: Manual therapy techniques in C0-1 and C2-3 with cervical exercise
description: Manual Therapy + Exercise group will carry out 20-minute session of treatment. The techniques will be applied depending on the clinical findings in each patient and the objective will be to restore the function of C0-1 and C2-3 segments before applying cervical exercises. We will use manipulation (high velocity low amplitude) and/or mobilization (low velocity high amplitude) techniques of C0-1 and C2-3 segments with cervical exercise. Manipulations will be in the direction of traction, with the head in a neutral position. A maximum of two trials at each level on each side will perform (2-6 thrusts). Mobilization will be performed for 5 minutes using repeating cycles of 45 seconds of mobilization and 15 seconds of rest. The cervical exercise will perform by this group will follow the same methodology as the Exercise group.
arm group label: Manual Therapy + Exercise Group
intervention type: Other
intervention name: Cervical Exercise
description: This group will perform the cervical stabilization exercise. They will be teach to perform the contraction of deep neck flexor muscle activity with the help of the Stabilizer Pressure Biofeedback Unit (Chattanooga, USA) in supine. Exercise will be always carry out without pain, because pain can be an inhibitor of muscle contraction.
The Exercise group will carry out one 20-minute session, composed of 2 sets of 10 repetitions, holding each repetition for 10 seconds, a 40-second rest between each repetition and 2 minutes between sets.
arm group label: Exercise Group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: No
last name: Jacobo Rodríguez-Sanz, PhD
phone: +34636136789
email: jacobors@unizar.es
facility: 
status: Recruiting
contact: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: Universidad de Zaragoza
investigator full name: Jacobo Rodríguez-Sanz
investigator title: Principal Investigator
mesh term: Spinal Diseases
mesh term: Neck Pain