<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/NCT04463199</url>
  </required_header>
  <id_info>
    <org_study_id>RRC-2019-08</org_study_id>
    <nct_id>NCT04463199</nct_id>
  </id_info>
  <brief_title>Effects of Deep Cervical Flexors Training On Forward Head Posture, Neck Pain and Functional Status</brief_title>
  <official_title>Effects of Deep Cervical Flexors Training On Forward Head Posture, Neck Pain and Functional Status in Adolescent Children Using Computer Regularly</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Saud University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Saud University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Using computer for long hours is related to higher risk of computer related muscular&#xD;
      disorders like forward head posture and neck pain. Deep cervical flexor muscles are important&#xD;
      head-on-neck posture stabilizers thus their training may lead to improvement in forward head&#xD;
      posture (FHP) and neck pain (NP).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In contemporary societies, computer use by children is a necessity and thus highly prevalent.&#xD;
      Using computer for long hours is related to higher risk of computer-related muscular&#xD;
      disorders like forward head posture and neck pain. Deep cervical flexor muscles are important&#xD;
      head-on-neck posture stabilizers thus their training may lead to improvement in forward head&#xD;
      posture (FHP) and neck pain (NP). Aim of study was to determine if 4 weeks of deep cervical&#xD;
      flexors training is effective in alleviating neck pain and improving forward head posture in&#xD;
      adolescent children using computer regularly. A pretest-posttest experimental group design&#xD;
      was used. Subjects were randomly assigned into control group (receiving postural advice only)&#xD;
      and experimental group (receiving deep cervical flexor training and postural advice).&#xD;
      Dependent variables were measured on day 0 (at baseline) and after 4weeks of training. The&#xD;
      photographic analysis was used for measuring forward head posture, visual analog scale (VAS)&#xD;
      for neck pain intensity and Neck Disability Index (NDI) for functional disability.&#xD;
      Experimental group received craniocervical flexion training for 4 weeks and postural advice.&#xD;
      Control group received only postural advice.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">February 20, 2019</start_date>
  <completion_date type="Actual">September 2, 2019</completion_date>
  <primary_completion_date type="Actual">August 12, 2019</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>Change in craniovertebral angle</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in the craniovertebral angle is assessed from baseline at 4 weeks interval.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Neck Disability Index</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in Functional status is assessed from baseline at 4 weeks interval.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Visual Analog Scale</measure>
    <time_frame>4 weeks</time_frame>
    <description>Change in Neck pain intensity assessed from baseline at 4 weeks interval. It is a scale on a piece of paper equal to the length of 10 cm. Each centimeter has 1 point, with 0 means &quot;no pain&quot; and 10 means &quot;worst pain felt ever&quot;. Lower the score, better the outcome measure.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Forward Head Posture</condition>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>Experimental</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental group received craniocervical flexion training for 4 weeks and postural advice</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Control group received only postural advice</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Craniocervical flexion training</intervention_name>
    <description>PBU airbag was clipped together and folded in, fastened, and placed suboccipital. Uninflated pressure sensor was kept below the neck, so that it touched the occiput then inflated to a stable baseline pressure of 20 mmHg to just fill the space below the neck but not to push it into lordosis. Subjects were demonstrated the correct action of the deep cervical flexors that is gentle nodding of head as if saying &quot;yes&quot;.</description>
    <arm_group_label>Experimental</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Neck pain with or without headache, of duration more than 3 months and less than 1&#xD;
             year and 6 months, as identified by body discomfort chart and&#xD;
&#xD;
          -  Neck disability index value less than 24 (mild to moderate disability scores on NDI)&#xD;
&#xD;
          -  Forward head posture as identified by straight line down from external meatus falling&#xD;
             anterior to shoulder and mid thorax.&#xD;
&#xD;
          -  Using computer for at least 3 hours a day for at least 4 days a week or more.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Ongoing or previous history of spinal fracture&#xD;
&#xD;
          -  Ongoing or previous history of neurological signs&#xD;
&#xD;
          -  Ongoing or previous history of inflammatory disease&#xD;
&#xD;
          -  Ongoing or previous history of spinal tumor&#xD;
&#xD;
          -  Ongoing or previous history of spinal infection&#xD;
&#xD;
          -  Ongoing or previous history of spinal cord compression&#xD;
&#xD;
          -  Ongoing or previous history of congenital, or acquired postural deformity&#xD;
&#xD;
          -  Ongoing or previous history of cervical spinal surgery&#xD;
&#xD;
          -  Ongoing or previous history of spinal instability&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>13 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>King Saud University</name>
      <address>
        <city>Riyadh</city>
        <zip>11433</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 5, 2020</study_first_submitted>
  <study_first_submitted_qc>July 8, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 9, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 13, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Saud University</investigator_affiliation>
    <investigator_full_name>Masood Khan</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Neck pain</keyword>
  <keyword>Forward head posture</keyword>
  <keyword>Deep cervical flexors</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Neck Pain</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT04463199
org study id: RRC-2019-08
nct id: NCT04463199
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Using computer for long hours is related to higher risk of computer related muscular
      disorders like forward head posture and neck pain. Deep cervical flexor muscles are important
      head-on-neck posture stabilizers thus their training may lead to improvement in forward head
      posture (FHP) and neck pain (NP).
In contemporary societies, computer use by children is a necessity and thus highly prevalent.
      Using computer for long hours is related to higher risk of computer-related muscular
      disorders like forward head posture and neck pain. Deep cervical flexor muscles are important
      head-on-neck posture stabilizers thus their training may lead to improvement in forward head
      posture (FHP) and neck pain (NP). Aim of study was to determine if 4 weeks of deep cervical
      flexors training is effective in alleviating neck pain and improving forward head posture in
      adolescent children using computer regularly. A pretest-posttest experimental group design
      was used. Subjects were randomly assigned into control group (receiving postural advice only)
      and experimental group (receiving deep cervical flexor training and postural advice).
      Dependent variables were measured on day 0 (at baseline) and after 4weeks of training. The
      photographic analysis was used for measuring forward head posture, visual analog scale (VAS)
      for neck pain intensity and Neck Disability Index (NDI) for functional disability.
      Experimental group received craniocervical flexion training for 4 weeks and postural advice.
      Control group received only postural advice.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in craniovertebral angle
time frame: 4 weeks
description: Change in the craniovertebral angle is assessed from baseline at 4 weeks interval.
measure: Change in Neck Disability Index
time frame: 4 weeks
description: Change in Functional status is assessed from baseline at 4 weeks interval.
measure: Change in Visual Analog Scale
time frame: 4 weeks
description: Change in Neck pain intensity assessed from baseline at 4 weeks interval. It is a scale on a piece of paper equal to the length of 10 cm. Each centimeter has 1 point, with 0 means "no pain" and 10 means "worst pain felt ever". Lower the score, better the outcome measure.
arm group label: Experimental
arm group type: Experimental
description: Experimental group received craniocervical flexion training for 4 weeks and postural advice
arm group label: Control Group
arm group type: No Intervention
description: Control group received only postural advice
intervention type: Other
intervention name: Craniocervical flexion training
description: PBU airbag was clipped together and folded in, fastened, and placed suboccipital. Uninflated pressure sensor was kept below the neck, so that it touched the occiput then inflated to a stable baseline pressure of 20 mmHg to just fill the space below the neck but not to push it into lordosis. Subjects were demonstrated the correct action of the deep cervical flexors that is gentle nodding of head as if saying "yes".
arm group label: Experimental
criteria: 
gender: All
minimum age: 13 Years
maximum age: 18 Years
healthy volunteers: No
facility: 
country: Saudi Arabia
responsible party type: Principal Investigator
investigator affiliation: King Saud University
investigator full name: Masood Khan
investigator title: Principal investigator
mesh term: Neck Pain
sharing ipd: Undecided