<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/NCT02222051</url>
  </required_header>
  <id_info>
    <org_study_id>13-5672 Tai Chi Neck Pain</org_study_id>
    <nct_id>NCT02222051</nct_id>
  </id_info>
  <brief_title>Tai Chi for Chronic Non-specific Neck Pain</brief_title>
  <acronym>TaiChiNe</acronym>
  <official_title>Tai Chi for Chronic Non-specific Neck Pain: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universität Duisburg-Essen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universität Duisburg-Essen</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      In this study the efficacy of Tai Chi will be tested in comparison to conventional neck&#xD;
      exercises and usual care in a randomized controlled trial. Tai Chi and neck exercises will be&#xD;
      lead by a trained exercise therapist and Tai Chi instructor, both groups receive 12 weeks of&#xD;
      training, once weekly for 60-90 min in a group setting. Pain, Disability, quality of life,&#xD;
      wellbeing, stress perception, psychological distress will be used to determine effects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      see above&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>August 2014</start_date>
  <completion_date type="Actual">April 2015</completion_date>
  <primary_completion_date type="Actual">December 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>pain intensity</measure>
    <time_frame>week 12</time_frame>
    <description>pain intensity on a visual analogue scale (0-100mm)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>pain intensity</measure>
    <time_frame>week 24</time_frame>
    <description>pain intensity on a visual analogue scale (0-100mm)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain on movement</measure>
    <time_frame>week 12, week 24</time_frame>
    <description>pain intensity on a visual analogue scale (0-100mm) evoked by head movement into 6 directions POM validated by Lauche et al., 2014, Pain Medicine</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>neck disability</measure>
    <time_frame>week 12, week 24</time_frame>
    <description>neck disability index (NDI), Vernon et al.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>health related quality of life</measure>
    <time_frame>week 12, week 24</time_frame>
    <description>short form quality of life questionnaire (SF-36), Bullinger and Kirchberger</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety and Depression</measure>
    <time_frame>week 12, week 24</time_frame>
    <description>Hospital Anxiety and Depression Scale (HADS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Wellbeing</measure>
    <time_frame>week 12, week 24</time_frame>
    <description>Wellbeing on the FEW16 Questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Stress</measure>
    <time_frame>week 12, week 24</time_frame>
    <description>Subjective stress perception, Perceived Stress Scale (PSS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>interoceptive awareness</measure>
    <time_frame>week 12, week 24</time_frame>
    <description>The Multidimensional Assessment of Interoceptive Awareness (MAIA)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postural Awareness</measure>
    <time_frame>week 12, week 24</time_frame>
    <description>Postural Awareness Questionnaire (PAS)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Safety</measure>
    <time_frame>week 24</time_frame>
    <description>All adverse and serious adverse events</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>pain intensity ratings</measure>
    <time_frame>week 12</time_frame>
    <description>daily rating of pain intensity, visual analog scales</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of analgetics</measure>
    <time_frame>week 12</time_frame>
    <description>daily information on use of analgetics</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>use of concomitant therapies</measure>
    <time_frame>week 12</time_frame>
    <description>daily information on use of concomitant therapies for neck pain</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Experiences</measure>
    <time_frame>Week 24</time_frame>
    <description>Experiences with Tai Chi and neck exercises, qualitative interviews</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">114</enrollment>
  <condition>Neck Pain</condition>
  <arm_group>
    <arm_group_label>Tai Chi</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Simplified 24 Yang Style 12 weeks, 1x/week, 60-90 minutes</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Neck exercise</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>conventional neck exercises 12 weeks, 1x/week, 60 min stretching and strengthening, neck education</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual care</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Usual care, no specific study intervention this group is offered Tai Chi or neck exercises at the end of the study</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Tai Chi</intervention_name>
    <description>traditional chinese martial art meditative movement technique</description>
    <arm_group_label>Tai Chi</arm_group_label>
    <other_name>Taiji</other_name>
    <other_name>T'ai Chi</other_name>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Neck exercises</intervention_name>
    <description>group exercises for strengthening and stretching neck and back muslces to alleviate neck pain</description>
    <arm_group_label>Neck exercise</arm_group_label>
    <other_name>neck training</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic non specific neck pain (3 months at least)&#xD;
&#xD;
          -  45mm pain intensity on average on the visual analog scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  specific neck pain due to&#xD;
&#xD;
          -  inflammatory diseases&#xD;
&#xD;
          -  rheumatic diseases&#xD;
&#xD;
          -  neurological diseases&#xD;
&#xD;
          -  prolapse or protrusion&#xD;
&#xD;
          -  oncological disease&#xD;
&#xD;
          -  trauma (whiplash)&#xD;
&#xD;
          -  congenital deformity of the spine&#xD;
&#xD;
          -  severe comorbidity (somatic, psychiatric)&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  participation in other clinical trials&#xD;
&#xD;
          -  regular practice of tai chi, qigong, yoga in the past 6 months&#xD;
&#xD;
          -  medication with opioids&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gustav Dobos, Prof.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Internal and Integrative Medicine, Kliniken Essen-Mitte</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Internal and Integrative Medicine, Kliniken Essen-Mitte</name>
      <address>
        <city>Essen</city>
        <state>NRW</state>
        <zip>45276</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Lauche R, Wayne PM, Fehr J, Stumpe C, Dobos G, Cramer H. Does Postural Awareness Contribute to Exercise-Induced Improvements in Neck Pain Intensity? A Secondary Analysis of a Randomized Controlled Trial Evaluating Tai Chi and Neck Exercises. Spine (Phila Pa 1976). 2017 Aug 15;42(16):1195-1200. doi: 10.1097/BRS.0000000000002078.</citation>
    <PMID>28146026</PMID>
  </reference>
  <results_reference>
    <citation>Lauche R, Stumpe C, Fehr J, Cramer H, Cheng YW, Wayne PM, Rampp T, Langhorst J, Dobos G. The Effects of Tai Chi and Neck Exercises in the Treatment of Chronic Nonspecific Neck Pain: A Randomized Controlled Trial. J Pain. 2016 Sep;17(9):1013-27. doi: 10.1016/j.jpain.2016.06.004. Epub 2016 Jun 23.</citation>
    <PMID>27345663</PMID>
  </results_reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 18, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>April 30, 2018</last_update_submitted>
  <last_update_submitted_qc>April 30, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">May 2, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universität Duisburg-Essen</investigator_affiliation>
    <investigator_full_name>Romy Lauche</investigator_full_name>
    <investigator_title>PhD</investigator_title>
  </responsible_party>
  <keyword>neck pain</keyword>
  <keyword>chronic pain</keyword>
  <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/NCT02222051
org study id: 13-5672 Tai Chi Neck Pain
nct id: NCT02222051
lead sponsor: 
has dmc: No
In this study the efficacy of Tai Chi will be tested in comparison to conventional neck
      exercises and usual care in a randomized controlled trial. Tai Chi and neck exercises will be
      lead by a trained exercise therapist and Tai Chi instructor, both groups receive 12 weeks of
      training, once weekly for 60-90 min in a group setting. Pain, Disability, quality of life,
      wellbeing, stress perception, psychological distress will be used to determine effects.
see above
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: pain intensity
time frame: week 12
description: pain intensity on a visual analogue scale (0-100mm)
measure: pain intensity
time frame: week 24
description: pain intensity on a visual analogue scale (0-100mm)
measure: pain on movement
time frame: week 12, week 24
description: pain intensity on a visual analogue scale (0-100mm) evoked by head movement into 6 directions POM validated by Lauche et al., 2014, Pain Medicine
measure: neck disability
time frame: week 12, week 24
description: neck disability index (NDI), Vernon et al.
measure: health related quality of life
time frame: week 12, week 24
description: short form quality of life questionnaire (SF-36), Bullinger and Kirchberger
measure: Anxiety and Depression
time frame: week 12, week 24
description: Hospital Anxiety and Depression Scale (HADS)
measure: Wellbeing
time frame: week 12, week 24
description: Wellbeing on the FEW16 Questionnaire
measure: Stress
time frame: week 12, week 24
description: Subjective stress perception, Perceived Stress Scale (PSS)
measure: interoceptive awareness
time frame: week 12, week 24
description: The Multidimensional Assessment of Interoceptive Awareness (MAIA)
measure: Postural Awareness
time frame: week 12, week 24
description: Postural Awareness Questionnaire (PAS)
measure: Safety
time frame: week 24
description: All adverse and serious adverse events
measure: pain intensity ratings
time frame: week 12
description: daily rating of pain intensity, visual analog scales
measure: use of analgetics
time frame: week 12
description: daily information on use of analgetics
measure: use of concomitant therapies
time frame: week 12
description: daily information on use of concomitant therapies for neck pain
measure: Experiences
time frame: Week 24
description: Experiences with Tai Chi and neck exercises, qualitative interviews
arm group label: Tai Chi
arm group type: Experimental
description: Simplified 24 Yang Style 12 weeks, 1x/week, 60-90 minutes
arm group label: Neck exercise
arm group type: Active Comparator
description: conventional neck exercises 12 weeks, 1x/week, 60 min stretching and strengthening, neck education
arm group label: Usual care
arm group type: No Intervention
description: Usual care, no specific study intervention this group is offered Tai Chi or neck exercises at the end of the study
intervention type: Behavioral
intervention name: Tai Chi
description: traditional chinese martial art meditative movement technique
arm group label: Tai Chi
other name: Taiji
other name: T'ai Chi
intervention type: Behavioral
intervention name: Neck exercises
description: group exercises for strengthening and stretching neck and back muslces to alleviate neck pain
arm group label: Neck exercise
other name: neck training
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Gustav Dobos, Prof.
role: Principal Investigator
affiliation: Department of Internal and Integrative Medicine, Kliniken Essen-Mitte
facility: 
country: Germany
citation: Lauche R, Wayne PM, Fehr J, Stumpe C, Dobos G, Cramer H. Does Postural Awareness Contribute to Exercise-Induced Improvements in Neck Pain Intensity? A Secondary Analysis of a Randomized Controlled Trial Evaluating Tai Chi and Neck Exercises. Spine (Phila Pa 1976). 2017 Aug 15;42(16):1195-1200. doi: 10.1097/BRS.0000000000002078.
PMID: 28146026
citation: Lauche R, Stumpe C, Fehr J, Cramer H, Cheng YW, Wayne PM, Rampp T, Langhorst J, Dobos G. The Effects of Tai Chi and Neck Exercises in the Treatment of Chronic Nonspecific Neck Pain: A Randomized Controlled Trial. J Pain. 2016 Sep;17(9):1013-27. doi: 10.1016/j.jpain.2016.06.004. Epub 2016 Jun 23.
PMID: 27345663
responsible party type: Principal Investigator
investigator affiliation: Universität Duisburg-Essen
investigator full name: Romy Lauche
investigator title: PhD
mesh term: Neck Pain