<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/NCT04457388</url>
  </required_header>
  <id_info>
    <org_study_id>AU/018</org_study_id>
    <nct_id>NCT04457388</nct_id>
  </id_info>
  <brief_title>Tele-Yoga Therapy for Chronic Pain</brief_title>
  <official_title>Tele- Yoga Therapy for Patients With Chronic Pain During Covid-19 Lockdown: A Prospective Non-randomized Single Arm Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarogyam UK</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Aarogyam UK</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>
      Chronic pain is highly prevalent and associated with a large symptom burden, that is had been&#xD;
      more concerning during Covid-19 outbreak and lockdown. Benefits of yoga in chronic pain&#xD;
      management are very well known. With this background we developed Tele-Yoga therapy program&#xD;
      and evaluated the success of this single arm study.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 25, 2020</start_date>
  <completion_date type="Actual">June 15, 2020</completion_date>
  <primary_completion_date type="Actual">June 15, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain Intensity</measure>
    <time_frame>From baseline to 6-week post intervention</time_frame>
    <description>visual-analogic scale (VAS), using pain level from &quot;no pain&quot; (0) to &quot;worst imaginable pain&quot; (10)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pain Disability</measure>
    <time_frame>From baseline to 6-week post intervention</time_frame>
    <description>Pain Disability Index (PDI) using seven rating scales, structured in Likert form, from &quot;no disability&quot; (0) to &quot;worst disability&quot; (10)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Anxiety</measure>
    <time_frame>From Baseline to 6-week post intervention</time_frame>
    <description>Hospital Anxiety Depression Scale, consisting of 7 scales for measuring anxiety levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Depression</measure>
    <time_frame>From baseline to 6-week post intervention</time_frame>
    <description>Hospital Anxiety Depression Scale, consisting of 7 scales for measuring depression levels</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">18</enrollment>
  <condition>Chronic Pain</condition>
  <arm_group>
    <arm_group_label>Tele-Yoga Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Individualised Yoga therapy based on participant's clinical condition and personal needs. Twice a week sessions were carried out by trained and experienced Yoga therapist via video conference with each therapy for individualized based on each participant.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tele-Yoga Therapy</intervention_name>
    <description>Yoga practices combining with joint loosening exercises (Sukshma Vyayama), postures (Asana), breathing exercises (Pranayama), relaxation techniques and chanting ( A, U, M, and AUM { ૐ}) syllable chants meditation. Each session ended with home practice exercises given to the participants to practice everyday.</description>
    <arm_group_label>Tele-Yoga Therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Chronic pain for at least 3 months&#xD;
&#xD;
          -  Having access to internet and video calls&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Pregnant or breast-feeding women,&#xD;
&#xD;
          -  Patients not willing to give written consent&#xD;
&#xD;
          -  Patients with severe psychiatric or personality disorder&#xD;
&#xD;
          -  Malignancy&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Neha Sharma</last_name>
    <role>Principal Investigator</role>
    <affiliation>Aarogyam UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dipa Modi</last_name>
    <role>Study Chair</role>
    <affiliation>Aarogyam UK</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Bhavna Pandya</last_name>
    <role>Study Chair</role>
    <affiliation>Aarogyam UK</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Aarogyam UK</name>
      <address>
        <city>Leicester</city>
        <state>Leicestershire</state>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>June 30, 2020</study_first_submitted>
  <study_first_submitted_qc>June 30, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 7, 2020</study_first_posted>
  <last_update_submitted>July 7, 2020</last_update_submitted>
  <last_update_submitted_qc>July 7, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 8, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tele-Yoga Therapy</keyword>
  <keyword>Chronic Pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chronic 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/NCT04457388
org study id: AU/018
nct id: NCT04457388
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Chronic pain is highly prevalent and associated with a large symptom burden, that is had been
      more concerning during Covid-19 outbreak and lockdown. Benefits of yoga in chronic pain
      management are very well known. With this background we developed Tele-Yoga therapy program
      and evaluated the success of this single arm study.
allocation: N/A
intervention model: Single Group Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Pain Intensity
time frame: From baseline to 6-week post intervention
description: visual-analogic scale (VAS), using pain level from "no pain" (0) to "worst imaginable pain" (10)
measure: Pain Disability
time frame: From baseline to 6-week post intervention
description: Pain Disability Index (PDI) using seven rating scales, structured in Likert form, from "no disability" (0) to "worst disability" (10)
measure: Anxiety
time frame: From Baseline to 6-week post intervention
description: Hospital Anxiety Depression Scale, consisting of 7 scales for measuring anxiety levels
measure: Depression
time frame: From baseline to 6-week post intervention
description: Hospital Anxiety Depression Scale, consisting of 7 scales for measuring depression levels
arm group label: Tele-Yoga Therapy
arm group type: Experimental
description: Individualised Yoga therapy based on participant's clinical condition and personal needs. Twice a week sessions were carried out by trained and experienced Yoga therapist via video conference with each therapy for individualized based on each participant.
intervention type: Other
intervention name: Tele-Yoga Therapy
description: Yoga practices combining with joint loosening exercises (Sukshma Vyayama), postures (Asana), breathing exercises (Pranayama), relaxation techniques and chanting ( A, U, M, and AUM { ૐ}) syllable chants meditation. Each session ended with home practice exercises given to the participants to practice everyday.
arm group label: Tele-Yoga Therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Neha Sharma
role: Principal Investigator
affiliation: Aarogyam UK
last name: Dipa Modi
role: Study Chair
affiliation: Aarogyam UK
last name: Bhavna Pandya
role: Study Chair
affiliation: Aarogyam UK
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Chronic Pain
sharing ipd: Undecided