<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/NCT02199405</url>
  </required_header>
  <id_info>
    <org_study_id>13066</org_study_id>
    <nct_id>NCT02199405</nct_id>
  </id_info>
  <brief_title>Study on the Early Warning and Treatment of Cervical Spondylosis of Cervical Type on Young People Based on the &quot; Move Generate Yang &quot; Theory</brief_title>
  <official_title>Study on the Early Warning and Treatment of Cervical Spondylosis of Cervical Type on Young People Based on the &quot; Move Generate Yang &quot; Theory</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Wang Yucheng</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>First Teaching Hospital of Tianjin University of Traditional Chinese Medicine</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The incidence of cervical spondylosis on young people is increasing every year. Suffering&#xD;
      from this disease will affect the normal life and learning of young people. Episode younger&#xD;
      and incidence higher of this disease could increase health care spending of the government in&#xD;
      the economy. Cervical spondylosis of cervical type is the main type of cervical spondylosis&#xD;
      of young people. Patients of cervical spondylosis of cervical type always manifest the head,&#xD;
      neck and shoulder pain accompanied by corresponding pressure point, the X-ray display of&#xD;
      Upper cervical curvature change and instability of intervertebral joint performance ,and the&#xD;
      dynamic lateral X-ray shows vertebral instability or trapezoidal change. The conservative&#xD;
      treatment is the primary and preferred treatment of the disease.&#xD;
&#xD;
      This study is designed as a random, control, single blind study. It will recruit 140 cases of&#xD;
      cervical spondylosis of cervical type. Both the treatment group and the control group will be&#xD;
      randomly assigned 70 cases. Patients in the treatment group will be treated by Massage of&#xD;
      chiropractic and adjusting cervical curvature and practice Sishi Daoyin for 4 weeks，and the&#xD;
      control group by conventional massage and cervical traction. The total study includes 2 views&#xD;
      that are baseline and post-4week intervention. At all of the 2 views, all participants will&#xD;
      be examined range of motion of cervical vertebra, cervical curvature, and Surface&#xD;
      Electromyography of neck muscles, and will be estimated scores of The Neck Disability&#xD;
      Index(NDI), the Northwick Park Neck Pain Questionnaire (NPQ),Short-form McGill Pain&#xD;
      Questionnaire(SF-MPQ) and Evaluation of the therapeutic effect. This study aims to&#xD;
      investigate the efficacy of Massage of chiropractic and adjusting cervical curvature and&#xD;
      Sishi Daoyin practice, and discover the correlation between these scales and these objective&#xD;
      indicators to discover the indicators of early warning signs of cervical spondylosis of&#xD;
      cervical type of young people.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Quality control: The study site and all researchers must comply with the required&#xD;
      qualifications. All researchers must be trained before the study. The study will take a&#xD;
      number of measures to ensure the recruitment of the required sample size, and compliance of&#xD;
      intervention providers and participants.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2014</start_date>
  <primary_completion_date type="Anticipated">September 2015</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>value of cervical curvature</measure>
    <time_frame>baseline and post- 4week intervention</time_frame>
    <description>We will examine the value of cervical curvature of participants at baseline and post- 4week intervention.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>range of motion of cervical vertebra</measure>
    <time_frame>baseline and post- 4week intervention</time_frame>
    <description>We will examine the range of motion of cervical vertebra, including cervical flexion, extension, flexion to the left, flexion to the right, rotation to the left and rotation to the right.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>value of Surface Electromyography of neck muscles</measure>
    <time_frame>baseline and post- 4week intervention</time_frame>
    <description>We will examine the value of Surface Electromyography of sternocleidomastoid muscle and upper trapezius muscle when they are cervical flexion, extension, flexion to the left and flexion to the right.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>scores of the Neck Disability Index(NDI)</measure>
    <time_frame>baseline and post- 4week intervention</time_frame>
    <description>We will estimate the scores of NDI of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>scores of the Northwick Park Neck Pain Questionnaire (NPQ)</measure>
    <time_frame>baseline and post- 4week intervention</time_frame>
    <description>We will estimate the scores of NPQ of participants.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>scores of Short-form McGill Pain Questionnaire(SF-MPQ)</measure>
    <time_frame>baseline and post- 4week intervention</time_frame>
    <description>We will estimate the scores of SF-MPQ of participants.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>degree of Evaluation of the therapeutic effect</measure>
    <time_frame>baseline and post- 4week intervention</time_frame>
    <description>We will estimate the degree of Evaluation of the therapeutic effect according to Standards of the diagnosis and the therapeutic effect of Disease and Syndrome of traditional Chinese medicine.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">140</enrollment>
  <condition>Cervical Spondylosis of Cervical Type</condition>
  <arm_group>
    <arm_group_label>massage and Sishi Daoyin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Massage of chiropractic and adjusting cervical curvature, 10 minutes, three times one week for 4 weeks Sishi Daoyin, practicing during 9-11am, once a day for 4 weeks</description>
  </arm_group>
  <arm_group>
    <arm_group_label>conventional massage and cervical traction</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventional massage , 15 minutes, three times one week for 4 weeks Cervical traction , 15 minutes, three times one week for 4 weeks</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Massage of chiropractic and adjusting cervical curvature</intervention_name>
    <description>Massage of chiropractic and adjusting cervical curvature, 10 minutes, three times one week for 4 weeks</description>
    <arm_group_label>massage and Sishi Daoyin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Sishi Daoyin</intervention_name>
    <description>Sishi Daoyin, practicing during 9-11am, once a day for 4 weeks</description>
    <arm_group_label>massage and Sishi Daoyin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>conventional massage</intervention_name>
    <description>Conventional massage , 15 minutes, three times one week for 4 weeks</description>
    <arm_group_label>conventional massage and cervical traction</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Cervical traction</intervention_name>
    <arm_group_label>conventional massage and cervical traction</arm_group_label>
    <other_name>Cervical traction , 15 minutes, three times one week for 4 weeks</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  meet the diagnostic criteria of cervical spondylosis of cervical type&#xD;
&#xD;
          -  first invasion and not receive any treatment&#xD;
&#xD;
          -  X-ray shows cervical curvature go straight&#xD;
&#xD;
          -  volunteered to join the test, and sign &quot; informed consent &quot; persons&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  suspected or confirmed bone and joint and soft tissue tumors, and so on&#xD;
&#xD;
          -  suffer from cardiovascular, lung, liver, kidney and hematopoietic system serious&#xD;
             illness or impairment&#xD;
&#xD;
          -  lesions of skin ( such as damage, burns, and so on ) where massage will be applied&#xD;
&#xD;
          -  severe congenital malformation of cervical vertebra&#xD;
&#xD;
          -  incapacitated or unable to independently read and write&#xD;
&#xD;
          -  other conditions which researchers consider appropriate to participate in this study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>18 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Jennifer Gao, Master</last_name>
    <phone>022-27432929</phone>
    <phone_ext>13920595861</phone_ext>
    <email>jennifergao1982@126.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>James Zhang, Master</last_name>
    <phone>022-27432929</phone>
    <phone_ext>13820590796</phone_ext>
    <email>james399@126.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>The First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine</name>
      <address>
        <city>Tianjin</city>
        <state>Tianjin</state>
        <zip>300193</zip>
        <country>China</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Yucheng Wang, Bachelor</last_name>
      <phone>022-27432186</phone>
      <phone_ext>13752366330</phone_ext>
      <email>wangyucheng2014512@126.com</email>
    </contact>
  </location>
  <location_countries>
    <country>China</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>July 23, 2014</study_first_submitted>
  <study_first_submitted_qc>July 23, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 24, 2014</study_first_posted>
  <last_update_submitted>September 1, 2014</last_update_submitted>
  <last_update_submitted_qc>September 1, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 3, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>First Teaching Hospital of Tianjin University of Traditional Chinese Medicine</investigator_affiliation>
    <investigator_full_name>Wang Yucheng</investigator_full_name>
    <investigator_title>First Teaching Hospital of Tianjin University of Traditional Chinese Medicine</investigator_title>
  </responsible_party>
  <keyword>Spondylosis, Massage Therapy, Exercise Therapy ,Treatment Efficacy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Spondylosis</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/NCT02199405
org study id: 13066
nct id: NCT02199405
lead sponsor: 
has dmc: No
The incidence of cervical spondylosis on young people is increasing every year. Suffering
      from this disease will affect the normal life and learning of young people. Episode younger
      and incidence higher of this disease could increase health care spending of the government in
      the economy. Cervical spondylosis of cervical type is the main type of cervical spondylosis
      of young people. Patients of cervical spondylosis of cervical type always manifest the head,
      neck and shoulder pain accompanied by corresponding pressure point, the X-ray display of
      Upper cervical curvature change and instability of intervertebral joint performance ,and the
      dynamic lateral X-ray shows vertebral instability or trapezoidal change. The conservative
      treatment is the primary and preferred treatment of the disease.

      This study is designed as a random, control, single blind study. It will recruit 140 cases of
      cervical spondylosis of cervical type. Both the treatment group and the control group will be
      randomly assigned 70 cases. Patients in the treatment group will be treated by Massage of
      chiropractic and adjusting cervical curvature and practice Sishi Daoyin for 4 weeks，and the
      control group by conventional massage and cervical traction. The total study includes 2 views
      that are baseline and post-4week intervention. At all of the 2 views, all participants will
      be examined range of motion of cervical vertebra, cervical curvature, and Surface
      Electromyography of neck muscles, and will be estimated scores of The Neck Disability
      Index(NDI), the Northwick Park Neck Pain Questionnaire (NPQ),Short-form McGill Pain
      Questionnaire(SF-MPQ) and Evaluation of the therapeutic effect. This study aims to
      investigate the efficacy of Massage of chiropractic and adjusting cervical curvature and
      Sishi Daoyin practice, and discover the correlation between these scales and these objective
      indicators to discover the indicators of early warning signs of cervical spondylosis of
      cervical type of young people.
Quality control: The study site and all researchers must comply with the required
      qualifications. All researchers must be trained before the study. The study will take a
      number of measures to ensure the recruitment of the required sample size, and compliance of
      intervention providers and participants.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: value of cervical curvature
time frame: baseline and post- 4week intervention
description: We will examine the value of cervical curvature of participants at baseline and post- 4week intervention.
measure: range of motion of cervical vertebra
time frame: baseline and post- 4week intervention
description: We will examine the range of motion of cervical vertebra, including cervical flexion, extension, flexion to the left, flexion to the right, rotation to the left and rotation to the right.
measure: value of Surface Electromyography of neck muscles
time frame: baseline and post- 4week intervention
description: We will examine the value of Surface Electromyography of sternocleidomastoid muscle and upper trapezius muscle when they are cervical flexion, extension, flexion to the left and flexion to the right.
measure: scores of the Neck Disability Index(NDI)
time frame: baseline and post- 4week intervention
description: We will estimate the scores of NDI of participants.
measure: scores of the Northwick Park Neck Pain Questionnaire (NPQ)
time frame: baseline and post- 4week intervention
description: We will estimate the scores of NPQ of participants.
measure: scores of Short-form McGill Pain Questionnaire(SF-MPQ)
time frame: baseline and post- 4week intervention
description: We will estimate the scores of SF-MPQ of participants.
measure: degree of Evaluation of the therapeutic effect
time frame: baseline and post- 4week intervention
description: We will estimate the degree of Evaluation of the therapeutic effect according to Standards of the diagnosis and the therapeutic effect of Disease and Syndrome of traditional Chinese medicine.
arm group label: massage and Sishi Daoyin
arm group type: Experimental
description: Massage of chiropractic and adjusting cervical curvature, 10 minutes, three times one week for 4 weeks Sishi Daoyin, practicing during 9-11am, once a day for 4 weeks
arm group label: conventional massage and cervical traction
arm group type: Active Comparator
description: Conventional massage , 15 minutes, three times one week for 4 weeks Cervical traction , 15 minutes, three times one week for 4 weeks
intervention type: Other
intervention name: Massage of chiropractic and adjusting cervical curvature
description: Massage of chiropractic and adjusting cervical curvature, 10 minutes, three times one week for 4 weeks
arm group label: massage and Sishi Daoyin
intervention type: Other
intervention name: Sishi Daoyin
description: Sishi Daoyin, practicing during 9-11am, once a day for 4 weeks
arm group label: massage and Sishi Daoyin
intervention type: Other
intervention name: conventional massage
description: Conventional massage , 15 minutes, three times one week for 4 weeks
arm group label: conventional massage and cervical traction
intervention type: Other
intervention name: Cervical traction
arm group label: conventional massage and cervical traction
other name: Cervical traction , 15 minutes, three times one week for 4 weeks
criteria: 
gender: All
minimum age: 15 Years
maximum age: 18 Years
healthy volunteers: No
last name: Jennifer Gao, Master
phone: 022-27432929
phone ext: 13920595861
email: jennifergao1982@126.com
last name: James Zhang, Master
phone: 022-27432929
phone ext: 13820590796
email: james399@126.com
facility: 
status: Recruiting
contact: 
country: China
responsible party type: Sponsor-Investigator
investigator affiliation: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
investigator full name: Wang Yucheng
investigator title: First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
mesh term: Spondylosis