<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/NCT02225873</url>
  </required_header>
  <id_info>
    <org_study_id>M2013/046/20140528</org_study_id>
    <nct_id>NCT02225873</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Exercises Protocol in Management of Neck Pain</brief_title>
  <official_title>The Effectiveness of Two Training Protocols When Managing Chronic Cervical Pain: Controlled Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alcala</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alcala</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will verify whether the cranio-cervical flexion coordination (motor control) and&#xD;
      muscle strength training protocol is more effective in improving muscle than the&#xD;
      proprioception and muscle strength protocol in patients with chronic neck pain.&#xD;
&#xD;
      Hypothesis: The craniocervical flexion (motor control) and muscle strength training protocol&#xD;
      will improve muscle function more than the proprioception and muscle strength protocol in&#xD;
      patients with chronic cervical pain.&#xD;
&#xD;
      Objective: To find out if applying the strength therapeutic exercise protocol and the&#xD;
      craniocervical flexion coordination (motor control) training is more effective than the&#xD;
      strength and articular repositioning protocol when carrying out the craniocervical flexion&#xD;
      test in patients with chronic cervical pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Neck pain is delimited by two horizontal lines, one through the lower portion of the&#xD;
      occipital region and one through the spinous process of the first thoracic vertebra. This&#xD;
      pain is reproduced by neck movements or exploratory provocation tests. Scientific studies&#xD;
      show that at least two out of three people will experience neck pain throughout life. Some of&#xD;
      the causes are traumatism and whiplash although sometimes pain is idiopathic.&#xD;
&#xD;
      This study will verify whether the cranio-cervical flexion coordination (motor control) and&#xD;
      muscle strength training protocol is more effective in improving muscle than the&#xD;
      proprioception and muscle strength protocol in patients with chronic neck pain.&#xD;
&#xD;
      The project design will be a randomized controlled evaluator-blinded clinical trial with two&#xD;
      intervention groups:&#xD;
&#xD;
      Group 1 (experimental) will carry out motor control exercises through cranio-cervical flexion&#xD;
      training and strength-endurance exercises.&#xD;
&#xD;
      Group 2 (control) will carry out exercises to improve muscle strength-endurance and&#xD;
      proprioception. Measurements will be done at the beginning of the study, pre and&#xD;
      post-treatment, one month and two months after treatment and throughout the six month&#xD;
      treatment. Each session will last 45 minutes and therapy will be performed without provoking&#xD;
      the patient symptoms.&#xD;
&#xD;
      Intervention&#xD;
&#xD;
      Experimental group 1: will carry out intermuscular coordination exercises through&#xD;
      cranio-cervical training, following Jull et al1, 2 and exercises to increase&#xD;
      strength-endurance on the neck flexor muscles.&#xD;
&#xD;
      Control group 2: will carry out proprioception exercises through articular repositioning&#xD;
      training and exercises to increase strength-endurance on the neck flexor muscles. They will&#xD;
      be performed in the same way as the experimental group protocol.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>September 2014</start_date>
  <completion_date type="Actual">January 2015</completion_date>
  <primary_completion_date type="Actual">November 2014</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 (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Craniocervical Flexion Test</measure>
    <time_frame>up to six months after treatment</time_frame>
    <description>This test measures the activation and resistance of the neck flexor muscles in 5 steps, with isometric contractions on the patient every 2 mmHg, increasing pressure sequentially from 20 mmHg up to 30 mmHg.&#xD;
Once carried out the test, performance will be measured by the pressure level achieved and the number of times pressure can be maintained by the patient with the correct cranioflexion movement in each level.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>strength-endurance exercises</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Group 1 (experimental) will carry out motor control exercises through cranio-cervical flexion training and strength-endurance exercises.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>strength-endurance and proprioception</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Group 2 (control) will carry out exercises to improve muscle strength-endurance and proprioception.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>motor control exercises</intervention_name>
    <description>Will carry out intermuscular coordination exercises through cranio-cervical training, following Jull et al. and exercises to increase strength-endurance on the neck flexor muscles</description>
    <arm_group_label>strength-endurance exercises</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>muscle strength-endurance and proprioception</intervention_name>
    <description>Will carry out proprioception exercises through articular repositioning training and exercises to increase strength-endurance on the neck flexor muscles. They will be performed in the same way as the experimental group protocol.</description>
    <arm_group_label>strength-endurance and proprioception</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  History of cervical pain of at least 3 months.&#xD;
&#xD;
          -  Between 18 and 55 years old.&#xD;
&#xD;
          -  Altered movement and/or loss of cervical control.&#xD;
&#xD;
          -  Pain after palpation of the muscles to be treated.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Previous history of central neurological condition.&#xD;
&#xD;
          -  Previous surgery of the cervical, cranial, scapular waist, upper limb or jaw.&#xD;
&#xD;
          -  Having received specific treatment or therapy of the cervical region in the 6 months&#xD;
             prior to the study.&#xD;
&#xD;
          -  Neck pain or headache with no musculo-skeletal causes.&#xD;
&#xD;
          -  Any other disorder that prevents physical activity.&#xD;
&#xD;
          -  Having received psychological treatment due to neck pain.&#xD;
&#xD;
          -  Patients with fibromyalgia, rheumatoid arthritis, vascular diseases, neoplasm or&#xD;
             vestibular system pathologies.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Tomas Gallego-Izquierdo, Dr</last_name>
    <role>Study Chair</role>
    <affiliation>Alcala University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Alcalá University</name>
      <address>
        <city>Alcala de Henares</city>
        <state>Madrid</state>
        <zip>28871</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <verification_date>November 2015</verification_date>
  <study_first_submitted>August 24, 2014</study_first_submitted>
  <study_first_submitted_qc>August 25, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 26, 2014</study_first_posted>
  <last_update_submitted>November 30, 2015</last_update_submitted>
  <last_update_submitted_qc>November 30, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 2, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alcala</investigator_affiliation>
    <investigator_full_name>Prof. Dr. Daniel Pecos Martín</investigator_full_name>
    <investigator_title>Dr.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <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/NCT02225873
org study id: M2013/046/20140528
nct id: NCT02225873
lead sponsor: 
has dmc: Yes
This study will verify whether the cranio-cervical flexion coordination (motor control) and
      muscle strength training protocol is more effective in improving muscle than the
      proprioception and muscle strength protocol in patients with chronic neck pain.

      Hypothesis: The craniocervical flexion (motor control) and muscle strength training protocol
      will improve muscle function more than the proprioception and muscle strength protocol in
      patients with chronic cervical pain.

      Objective: To find out if applying the strength therapeutic exercise protocol and the
      craniocervical flexion coordination (motor control) training is more effective than the
      strength and articular repositioning protocol when carrying out the craniocervical flexion
      test in patients with chronic cervical pain.
Neck pain is delimited by two horizontal lines, one through the lower portion of the
      occipital region and one through the spinous process of the first thoracic vertebra. This
      pain is reproduced by neck movements or exploratory provocation tests. Scientific studies
      show that at least two out of three people will experience neck pain throughout life. Some of
      the causes are traumatism and whiplash although sometimes pain is idiopathic.

      This study will verify whether the cranio-cervical flexion coordination (motor control) and
      muscle strength training protocol is more effective in improving muscle than the
      proprioception and muscle strength protocol in patients with chronic neck pain.

      The project design will be a randomized controlled evaluator-blinded clinical trial with two
      intervention groups:

      Group 1 (experimental) will carry out motor control exercises through cranio-cervical flexion
      training and strength-endurance exercises.

      Group 2 (control) will carry out exercises to improve muscle strength-endurance and
      proprioception. Measurements will be done at the beginning of the study, pre and
      post-treatment, one month and two months after treatment and throughout the six month
      treatment. Each session will last 45 minutes and therapy will be performed without provoking
      the patient symptoms.

      Intervention

      Experimental group 1: will carry out intermuscular coordination exercises through
      cranio-cervical training, following Jull et al1, 2 and exercises to increase
      strength-endurance on the neck flexor muscles.

      Control group 2: will carry out proprioception exercises through articular repositioning
      training and exercises to increase strength-endurance on the neck flexor muscles. They will
      be performed in the same way as the experimental group protocol.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Craniocervical Flexion Test
time frame: up to six months after treatment
description: This test measures the activation and resistance of the neck flexor muscles in 5 steps, with isometric contractions on the patient every 2 mmHg, increasing pressure sequentially from 20 mmHg up to 30 mmHg.
Once carried out the test, performance will be measured by the pressure level achieved and the number of times pressure can be maintained by the patient with the correct cranioflexion movement in each level.
arm group label: strength-endurance exercises
arm group type: Experimental
description: Group 1 (experimental) will carry out motor control exercises through cranio-cervical flexion training and strength-endurance exercises.
arm group label: strength-endurance and proprioception
arm group type: Placebo Comparator
description: Group 2 (control) will carry out exercises to improve muscle strength-endurance and proprioception.
intervention type: Other
intervention name: motor control exercises
description: Will carry out intermuscular coordination exercises through cranio-cervical training, following Jull et al. and exercises to increase strength-endurance on the neck flexor muscles
arm group label: strength-endurance exercises
intervention type: Other
intervention name: muscle strength-endurance and proprioception
description: Will carry out proprioception exercises through articular repositioning training and exercises to increase strength-endurance on the neck flexor muscles. They will be performed in the same way as the experimental group protocol.
arm group label: strength-endurance and proprioception
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Tomas Gallego-Izquierdo, Dr
role: Study Chair
affiliation: Alcala University
facility: 
country: Spain
responsible party type: Principal Investigator
investigator affiliation: University of Alcala
investigator full name: Prof. Dr. Daniel Pecos Martín
investigator title: Dr.
mesh term: Neck Pain