<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/NCT03840304</url>
  </required_header>
  <id_info>
    <org_study_id>NMP 0198</org_study_id>
    <nct_id>NCT03840304</nct_id>
  </id_info>
  <brief_title>Effect of Yoga@Work Program</brief_title>
  <official_title>Effectiveness of Yoga@Work Program on Neck and Shoulder Pain in Information Technology (IT) Employees</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>NMP Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Warwick Research Services</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Yog-Kulam</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>NMP Medical Research Institute</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>
      Employees working in IT industry are prone to develop musculoskeletal pain,specifically back,&#xD;
      neck and shoulder pain. This study evaluates the effectiveness of work-site yoga&#xD;
      intervention, Yoga@work on neck and shoulder pain in IT employees.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 12, 2018</start_date>
  <completion_date type="Actual">January 28, 2019</completion_date>
  <primary_completion_date type="Actual">December 12, 2018</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>Visual analogue scale for pain</measure>
    <time_frame>change from baseline to 8 weeks</time_frame>
    <description>100-mm visual analog scale (VAS), horizontal line ranging from 0mm (no pain) to 100mm (worst imaginable pain).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Neck disability index (NDI)</measure>
    <time_frame>Change from baseline to 8-weeks</time_frame>
    <description>The NDI is a standard instrument for measuring self-rated disability due to neck pain.10-item, 50-point index; each of the 10 items is scored from 0 - 5. Higher points represent worse pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Shoulder pain disability index</measure>
    <time_frame>Change from baseline to 8-weeks</time_frame>
    <description>The SPADI is a 13-item patient completed instrument. Its categories include pain (5 items) and disability (8 items), overall total scores range from 0 to 130. Higher score represent worse disability</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">132</enrollment>
  <condition>Musculoskeletal Pain</condition>
  <condition>Neck Pain</condition>
  <condition>Shoulder Pain</condition>
  <arm_group>
    <arm_group_label>Yoga Group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Participants in the intervention group engaged in a 8-week yoga program delivered at their place of work (IT companies). Sessions were group-based, prescribed three sessions per week during break time (30-mins).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Wait-list Group</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Participants in Wait-List control were not given any intervention. 8-weeks, group followed usual break time.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Yoga@work</intervention_name>
    <description>Each session included warm-up practices(for the large joints, spine, and extremities), Physical postures (Asana), breathing exercises (pranayama) and supine meditation/relaxation (savasana).</description>
    <arm_group_label>Yoga Group</arm_group_label>
    <other_name>Yoga</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  IT companies employee&#xD;
&#xD;
          -  Full time employment&#xD;
&#xD;
          -  Neck and Shoulder Pain&#xD;
&#xD;
          -  pain of at least 3 months duration&#xD;
&#xD;
          -  able to comply with intervention schedule&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Refuse to give informed consent&#xD;
&#xD;
          -  spinal fracture&#xD;
&#xD;
          -  recent cervical spine or shoulder surgery&#xD;
&#xD;
          -  recent (3 months) chemotherapy/radiotherapy/ intervention&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neha Sharma</last_name>
    <role>Study Director</role>
    <affiliation>Yog-Kulam</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Durga Prasad Sharma</last_name>
    <role>Study Chair</role>
    <affiliation>International Labour Organization, UN</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Divya Gaur</last_name>
    <role>Principal Investigator</role>
    <affiliation>NMP Medical Research Institute, India</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NMP Medical Reserach Institute</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>February 9, 2019</study_first_submitted>
  <study_first_submitted_qc>February 11, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 15, 2019</study_first_posted>
  <last_update_submitted>February 20, 2019</last_update_submitted>
  <last_update_submitted_qc>February 20, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 21, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Shoulder Pain</mesh_term>
    <mesh_term>Musculoskeletal Pain</mesh_term>
    <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/NCT03840304
org study id: NMP 0198
nct id: NCT03840304
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Employees working in IT industry are prone to develop musculoskeletal pain,specifically back,
      neck and shoulder pain. This study evaluates the effectiveness of work-site yoga
      intervention, Yoga@work on neck and shoulder pain in IT employees.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Visual analogue scale for pain
time frame: change from baseline to 8 weeks
description: 100-mm visual analog scale (VAS), horizontal line ranging from 0mm (no pain) to 100mm (worst imaginable pain).
measure: Neck disability index (NDI)
time frame: Change from baseline to 8-weeks
description: The NDI is a standard instrument for measuring self-rated disability due to neck pain.10-item, 50-point index; each of the 10 items is scored from 0 - 5. Higher points represent worse pain
measure: Shoulder pain disability index
time frame: Change from baseline to 8-weeks
description: The SPADI is a 13-item patient completed instrument. Its categories include pain (5 items) and disability (8 items), overall total scores range from 0 to 130. Higher score represent worse disability
arm group label: Yoga Group
arm group type: Experimental
description: Participants in the intervention group engaged in a 8-week yoga program delivered at their place of work (IT companies). Sessions were group-based, prescribed three sessions per week during break time (30-mins).
arm group label: Wait-list Group
arm group type: No Intervention
description: Participants in Wait-List control were not given any intervention. 8-weeks, group followed usual break time.
intervention type: Other
intervention name: Yoga@work
description: Each session included warm-up practices(for the large joints, spine, and extremities), Physical postures (Asana), breathing exercises (pranayama) and supine meditation/relaxation (savasana).
arm group label: Yoga Group
other name: Yoga
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: No
last name: Neha Sharma
role: Study Director
affiliation: Yog-Kulam
last name: Durga Prasad Sharma
role: Study Chair
affiliation: International Labour Organization, UN
last name: Divya Gaur
role: Principal Investigator
affiliation: NMP Medical Research Institute, India
facility: 
country: India
responsible party type: Sponsor
mesh term: Shoulder Pain
mesh term: Musculoskeletal Pain
mesh term: Neck Pain
sharing ipd: Undecided