<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/NCT02209480</url>
  </required_header>
  <id_info>
    <org_study_id>07-3497</org_study_id>
    <nct_id>NCT02209480</nct_id>
  </id_info>
  <brief_title>Alexander Technique Neck Pain</brief_title>
  <acronym>ATNeck</acronym>
  <official_title>Randomized Controlled Trial on the Efficacy of F.M. Alexander Technique in Chronic Neck Pain Patients</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>
      This study aimed to test the efficacy of five Alexander Technique lessons compared to the&#xD;
      same period of heat pad application and guided imagery in patients with chronic non-specific&#xD;
      neck pain.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      see above&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>December 2007</start_date>
  <completion_date type="Actual">August 2008</completion_date>
  <primary_completion_date type="Actual">August 2008</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>neck pain intensity</measure>
    <time_frame>5 weeks</time_frame>
    <description>neck pain intensity measured on a 100mm visual analog scales&#xD;
comparison Alexander technique vs. heat pad&#xD;
comparison Alexander technique vs. guided imagery</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>quality of life</measure>
    <time_frame>5 weeks</time_frame>
    <description>quality of life measured by the SF-36 questionnaire</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pain on motion</measure>
    <time_frame>5 weeks</time_frame>
    <description>pain on motion (movement of head in different directions) measured by the POM (Lauche, 2014, pain medicine)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Medication</measure>
    <time_frame>5 weeks</time_frame>
    <description>weekly dose of medication calculated as the defined daily dose according to WHO</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>functional disability</measure>
    <time_frame>5 weeks</time_frame>
    <description>measured by the neck disability index (NDI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>satisfaction</measure>
    <time_frame>5 weeks</time_frame>
    <description>satisfaction measured on a visual analog scale and via questions like &quot;would you consider using it again&quot; or &quot;would you recommend it&quot;</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>safety</measure>
    <time_frame>5 weeks</time_frame>
    <description>any adverse event during the study period</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">72</enrollment>
  <condition>Chronic Non-specific Neck Pain</condition>
  <arm_group>
    <arm_group_label>Alexander Technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>5 lessons of AT, each lasting up to 45 minutes, weekly intervals The lessons aimed at sensory awareness of everyday movements and movement sequences, such as sitting, walking, lying, or lifting in order to replace habitual patterns using conscious control; and different techniques were applied, such as demonstration, verbal instructions, hands on techniques and others</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Heat pad application</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>5 treatments by means of a heat pad, 15-0 minutes, sitting or lying position, quiet room Heat pad: Zapp-Sack® contained certain grains and a ginger extract, and could be heated up in the microwave.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>guided imagery</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>guided imagery relaxation technique , 45 minutes, 5 sessions in weekly rhythm including body scan, breathing relaxation, visualization</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Alexander Technique</intervention_name>
    <arm_group_label>Alexander Technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Heat pad application</intervention_name>
    <arm_group_label>Heat pad application</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>guided imagery</intervention_name>
    <arm_group_label>guided imagery</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  chronic non-specific neck pain&#xD;
&#xD;
          -  at least 3 months&#xD;
&#xD;
          -  40mm pain intensity on visual analog scale&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  neck pain as consequence of disc protrusion or prolapse, whiplash, congenital&#xD;
             deformity of the spine, spinal stenosis, neoplasm, inflammatory rheumatic disease,&#xD;
             neurological disorder,&#xD;
&#xD;
          -  active oncologic disease&#xD;
&#xD;
          -  affective disorder&#xD;
&#xD;
          -  addiction&#xD;
&#xD;
          -  psychosis.&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  invasive treatment of the spine within the previous three weeks&#xD;
&#xD;
          -  spinal surgery&#xD;
&#xD;
          -  previous experiences in Alexander Technique&#xD;
&#xD;
          -  ongoing application for disability pension&#xD;
&#xD;
          -  simultaneous participation in other clinical trials on neck pain&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Department of Internal and Integrative Medicine, Kliniken Essen-Mitte</name>
      <address>
        <city>Essen</city>
        <zip>45276</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <results_reference>
    <citation>Lauche R, Schuth M, Schwickert M, Ludtke R, Musial F, Michalsen A, Dobos G, Choi KE. Efficacy of the Alexander Technique in treating chronic non-specific neck pain: a randomized controlled trial. Clin Rehabil. 2016 Mar;30(3):247-58. doi: 10.1177/0269215515578699. Epub 2015 Mar 31.</citation>
    <PMID>25834276</PMID>
  </results_reference>
  <verification_date>April 2018</verification_date>
  <study_first_submitted>August 4, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 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>Principle Investigator</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/NCT02209480
org study id: 07-3497
nct id: NCT02209480
lead sponsor: 
has dmc: No
This study aimed to test the efficacy of five Alexander Technique lessons compared to the
      same period of heat pad application and guided imagery in patients with chronic non-specific
      neck pain.
see above
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: neck pain intensity
time frame: 5 weeks
description: neck pain intensity measured on a 100mm visual analog scales
comparison Alexander technique vs. heat pad
comparison Alexander technique vs. guided imagery
measure: quality of life
time frame: 5 weeks
description: quality of life measured by the SF-36 questionnaire
measure: Pain on motion
time frame: 5 weeks
description: pain on motion (movement of head in different directions) measured by the POM (Lauche, 2014, pain medicine)
measure: Medication
time frame: 5 weeks
description: weekly dose of medication calculated as the defined daily dose according to WHO
measure: functional disability
time frame: 5 weeks
description: measured by the neck disability index (NDI)
measure: satisfaction
time frame: 5 weeks
description: satisfaction measured on a visual analog scale and via questions like "would you consider using it again" or "would you recommend it"
measure: safety
time frame: 5 weeks
description: any adverse event during the study period
arm group label: Alexander Technique
arm group type: Experimental
description: 5 lessons of AT, each lasting up to 45 minutes, weekly intervals The lessons aimed at sensory awareness of everyday movements and movement sequences, such as sitting, walking, lying, or lifting in order to replace habitual patterns using conscious control; and different techniques were applied, such as demonstration, verbal instructions, hands on techniques and others
arm group label: Heat pad application
arm group type: Active Comparator
description: 5 treatments by means of a heat pad, 15-0 minutes, sitting or lying position, quiet room Heat pad: Zapp-Sack® contained certain grains and a ginger extract, and could be heated up in the microwave.
arm group label: guided imagery
arm group type: Active Comparator
description: guided imagery relaxation technique , 45 minutes, 5 sessions in weekly rhythm including body scan, breathing relaxation, visualization
intervention type: Behavioral
intervention name: Alexander Technique
arm group label: Alexander Technique
intervention type: Device
intervention name: Heat pad application
arm group label: Heat pad application
intervention type: Behavioral
intervention name: guided imagery
arm group label: guided imagery
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
facility: 
country: Germany
citation: Lauche R, Schuth M, Schwickert M, Ludtke R, Musial F, Michalsen A, Dobos G, Choi KE. Efficacy of the Alexander Technique in treating chronic non-specific neck pain: a randomized controlled trial. Clin Rehabil. 2016 Mar;30(3):247-58. doi: 10.1177/0269215515578699. Epub 2015 Mar 31.
PMID: 25834276
responsible party type: Principal Investigator
investigator affiliation: Universität Duisburg-Essen
investigator full name: Romy Lauche
investigator title: Principle Investigator
mesh term: Neck Pain