<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/NCT03757520</url>
  </required_header>
  <id_info>
    <org_study_id>0018827704</org_study_id>
    <nct_id>NCT03757520</nct_id>
  </id_info>
  <brief_title>Evaluation of Text Neck Syndrome and Hand Grip Force in Smart Phone Addiction Among Students of Jazan University</brief_title>
  <official_title>Evaluation of Text Neck Syndrome and Hand Grip Force in Smart Phone Addiction Among Students of Jazan University</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wafaa Mahmoud Amin</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Jazan</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>
      This study will be conducted in the Department of physical therapy, College of Applied&#xD;
      Medical Sciences,Jazan University, to investigate text neck syndrome and hand grip force in&#xD;
      smart phone addiction among students of jazan university&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Four hundreds students with age 19 to 26 years old, and right dominant hand, will be&#xD;
      recruited from the College of Applied Medical Sciences, Jazan University. Subjects will be&#xD;
      randomly assigned to into a heavy user group (n=300; female and male students) and a control&#xD;
      or regular use group (n=300; female and male students) according to their smartphone&#xD;
      addiction proneness scale.&#xD;
&#xD;
      Baseline hydraulic hand dynamometer: (Fabrication Enterprises Incorporated, White Plains,New&#xD;
      York, USA) is used to measure the hand grip strength and pinch strength.&#xD;
&#xD;
      Algometer Commander (JTech Medical Company) is used on the location of the trigger point to&#xD;
      assess the amount of pressure the patient could sustain before the patient registered the&#xD;
      pressure as being painful for upper fiber of trapezius muscle and sternocleidomastoid muscle&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 11, 2019</start_date>
  <completion_date type="Actual">October 18, 2020</completion_date>
  <primary_completion_date type="Actual">August 16, 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>Factorial Assignment</intervention_model>
    <intervention_model_description>According two Smartphone Addiction Proneness Scale (SAPS) the subjects will be divided into two groups: Regular user group with SAPS score 39 or less. Heavy user group with SAPS score 40 or more.&#xD;
we have two variables to be assessed:&#xD;
Pain pressure threshold for two muscles (upper fiber of trapezius and sternocleidomastoid muscle)&#xD;
Hand grip force</intervention_model_description>
    <primary_purpose>Diagnostic</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain pressure threshold for upper fiber of trapezius muscle</measure>
    <time_frame>3 minutes</time_frame>
    <description>Using Algometer to measure pain pressure for upper trapezius trigger point which lies in the more horizontal fibers of the upper trapezius on the back of the shoulder, about halfway between spine and the acromion on right and left side for 3 repetition for each</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Pain pressure threshold for sternocleidomastoid muscle</measure>
    <time_frame>9 minutes</time_frame>
    <description>Using Algometer to measure pain pressure for sternocleidomastoid muscle on right and left side for 3 repetition for each. Measurement will includes three sites on each side:&#xD;
1. upper part of the sternal division of the muscle near to its insertion into the mastoid process. 2. he mid-part of the sternal division of the muscle. 3. lower end of this division near to its attachment to the sternum.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Hand Grip Force</measure>
    <time_frame>15 minutes</time_frame>
    <description>For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.&#xD;
The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation.The test will be performed twice, and the higher value between the two measurements will be selected.&#xD;
The subjects are allowed a rest time of more than 5 minutes after the first measurement to avoid examiner bias and to decrease physical stress</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">600</enrollment>
  <condition>Pain, Back</condition>
  <condition>Neck Pain</condition>
  <condition>Postural; Strain</condition>
  <condition>Myofascial Pain Syndrome</condition>
  <arm_group>
    <arm_group_label>Regular user group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Their number: 300; female and male students, will earn 39 points or less of Smartphone Addiction Proneness Scale. Pain Pressure Threshold and Hand Grip Force will Measured for them.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heavy user group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Their number: 300; female and male students, will earn 40 points or more of Smartphone Addiction Proneness Scale. Pain Pressure Threshold and Hand Grip Force will Measured for them.</description>
  </arm_group>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Pain Pressure Threshold</intervention_name>
    <description>The pain pressure thresholds (PPTs) will be measured using an pressure algometer commander over potential trigger points (TrPs) on the body for upper fiber of trapezius, and sternocleidomastoid muscle.</description>
    <arm_group_label>Heavy user group</arm_group_label>
    <arm_group_label>Regular user group</arm_group_label>
    <other_name>PPTs</other_name>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>Hand Grip Force</intervention_name>
    <description>For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.&#xD;
The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation The test will be performed twice, and the higher value between the two measurements will be selected.</description>
    <arm_group_label>Heavy user group</arm_group_label>
    <arm_group_label>Regular user group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. The participant will be right-handed.&#xD;
&#xD;
          2. No abnormal findings confirmed through physical and neurological examination.&#xD;
&#xD;
          3. No congenital abnormalities in either the cervical or the lumbar spine.&#xD;
&#xD;
          4. No history of severe surgical procedures ( Park et al., 2015) .&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. History of a neurological disease.&#xD;
&#xD;
          2. History of musculoskeletal injury of neck and lumbar region.&#xD;
&#xD;
          3. Unstable medical condition.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>19 Years</minimum_age>
    <maximum_age>26 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jazan University</name>
      <address>
        <city>Riyadh</city>
        <state>Jazan</state>
        <zip>45142</zip>
        <country>Saudi Arabia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Saudi Arabia</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 23, 2018</study_first_submitted>
  <study_first_submitted_qc>November 27, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 29, 2018</study_first_posted>
  <last_update_submitted>November 7, 2020</last_update_submitted>
  <last_update_submitted_qc>November 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Jazan</investigator_affiliation>
    <investigator_full_name>Wafaa Mahmoud Amin</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Myofascial Pain Syndromes</mesh_term>
    <mesh_term>Fibromyalgia</mesh_term>
    <mesh_term>Syndrome</mesh_term>
    <mesh_term>Neck Pain</mesh_term>
    <mesh_term>Back Pain</mesh_term>
    <mesh_term>Internet Addiction Disorder</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
    <ipd_description>there is no plan</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/NCT03757520
org study id: 0018827704
nct id: NCT03757520
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will be conducted in the Department of physical therapy, College of Applied
      Medical Sciences,Jazan University, to investigate text neck syndrome and hand grip force in
      smart phone addiction among students of jazan university
Four hundreds students with age 19 to 26 years old, and right dominant hand, will be
      recruited from the College of Applied Medical Sciences, Jazan University. Subjects will be
      randomly assigned to into a heavy user group (n=300; female and male students) and a control
      or regular use group (n=300; female and male students) according to their smartphone
      addiction proneness scale.

      Baseline hydraulic hand dynamometer: (Fabrication Enterprises Incorporated, White Plains,New
      York, USA) is used to measure the hand grip strength and pinch strength.

      Algometer Commander (JTech Medical Company) is used on the location of the trigger point to
      assess the amount of pressure the patient could sustain before the patient registered the
      pressure as being painful for upper fiber of trapezius muscle and sternocleidomastoid muscle
allocation: Randomized
intervention model: Factorial Assignment
intervention model description: According two Smartphone Addiction Proneness Scale (SAPS) the subjects will be divided into two groups: Regular user group with SAPS score 39 or less. Heavy user group with SAPS score 40 or more.
we have two variables to be assessed:
Pain pressure threshold for two muscles (upper fiber of trapezius and sternocleidomastoid muscle)
Hand grip force
primary purpose: Diagnostic
masking: None (Open Label)
measure: Pain pressure threshold for upper fiber of trapezius muscle
time frame: 3 minutes
description: Using Algometer to measure pain pressure for upper trapezius trigger point which lies in the more horizontal fibers of the upper trapezius on the back of the shoulder, about halfway between spine and the acromion on right and left side for 3 repetition for each
measure: Pain pressure threshold for sternocleidomastoid muscle
time frame: 9 minutes
description: Using Algometer to measure pain pressure for sternocleidomastoid muscle on right and left side for 3 repetition for each. Measurement will includes three sites on each side:
1. upper part of the sternal division of the muscle near to its insertion into the mastoid process. 2. he mid-part of the sternal division of the muscle. 3. lower end of this division near to its attachment to the sternum.
measure: Hand Grip Force
time frame: 15 minutes
description: For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.
The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation.The test will be performed twice, and the higher value between the two measurements will be selected.
The subjects are allowed a rest time of more than 5 minutes after the first measurement to avoid examiner bias and to decrease physical stress
arm group label: Regular user group
arm group type: Active Comparator
description: Their number: 300; female and male students, will earn 39 points or less of Smartphone Addiction Proneness Scale. Pain Pressure Threshold and Hand Grip Force will Measured for them.
arm group label: Heavy user group
arm group type: Active Comparator
description: Their number: 300; female and male students, will earn 40 points or more of Smartphone Addiction Proneness Scale. Pain Pressure Threshold and Hand Grip Force will Measured for them.
intervention type: Diagnostic Test
intervention name: Pain Pressure Threshold
description: The pain pressure thresholds (PPTs) will be measured using an pressure algometer commander over potential trigger points (TrPs) on the body for upper fiber of trapezius, and sternocleidomastoid muscle.
arm group label: Heavy user group
arm group label: Regular user group
other name: PPTs
intervention type: Diagnostic Test
intervention name: Hand Grip Force
description: For measuring the grip strength, the subjects will be asked to sit on a chair with their hip joint flexed at 90 degree, and shoulder joint in a neutral position.
The elbow is fixed at 90 degree flexion, forearm in a neutral position, and wrist at 0 to 15 degree radial deviation The test will be performed twice, and the higher value between the two measurements will be selected.
arm group label: Heavy user group
arm group label: Regular user group
criteria: 
gender: All
minimum age: 19 Years
maximum age: 26 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Saudi Arabia
responsible party type: Sponsor-Investigator
investigator affiliation: University of Jazan
investigator full name: Wafaa Mahmoud Amin
investigator title: Principal Investigator
mesh term: Myofascial Pain Syndromes
mesh term: Fibromyalgia
mesh term: Syndrome
mesh term: Neck Pain
mesh term: Back Pain
mesh term: Internet Addiction Disorder
sharing ipd: Undecided
ipd description: there is no plan