<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/NCT04466605</url>
  </required_header>
  <id_info>
    <org_study_id>AU/NMP/0921</org_study_id>
    <nct_id>NCT04466605</nct_id>
  </id_info>
  <brief_title>Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown</brief_title>
  <official_title>Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aarogyam UK</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>NMP Medical Research Institute</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </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>
      Covid-19 outbreak and lockdown measures raised significant concerns over clinical management&#xD;
      of chronic pain patients around the world. Patients with chronic musculoskeletal pain (CMSP)&#xD;
      are at high risk of physical disability, psychological distress, and poor quality of life.&#xD;
      Analgesic medications were main management during lockdown, but opioid-related concerns have&#xD;
      prompted to find immediate alternatives.&#xD;
&#xD;
      Present study was undertaken to determine whether patients randomized to tele-yoga therapy&#xD;
      would experience less pain, disability and improved global health, adherence and&#xD;
      satisfaction, compared with patients assigned to usual care.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">March 30, 2020</start_date>
  <completion_date type="Actual">July 6, 2020</completion_date>
  <primary_completion_date type="Actual">June 30, 2020</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>Supportive Care</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Severity of pain</measure>
    <time_frame>From baseline to 6-week post intervention</time_frame>
    <description>Pain was assessed using the Brief Pain Inventory (BPI), which rates the severity of pain on 4 items (current, worst, least, and average pain in past week)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Interference of pain</measure>
    <time_frame>From baseline to 6-week post intervention</time_frame>
    <description>Interference of pain in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life) were reported using BPI</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Global rating of change in pain</measure>
    <time_frame>From baseline to 6-week post interventiona</time_frame>
    <description>7-point global rating of pain change was used to assess change in pain</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intervention specific satisfaction</measure>
    <time_frame>From baseline to 6-week post interventiona</time_frame>
    <description>10 point scale was used to assess intervention-specific satisfaction</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">64</enrollment>
  <condition>Chronic Musculoskeletal Pain</condition>
  <arm_group>
    <arm_group_label>Tele-Yoga Therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>All patients randomized to the intervention group had one to one yoga sessions with yoga therapist twice a week for 45 minutes on secure virtual platform. Patients were encouraged with home practice to follow everyday at least for 30-mins.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Usual Care</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients randomized to usual care continued to receive care for their chronic musculoskeletal pain from their primary care physician. There was no attempt by to influence clinical management unless an emergency arose</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Tele-yoga therapy</intervention_name>
    <description>Each session included combinations of different yoga exercises, postures, yoga breathing, yoga relaxation techniques, yoga counselling and meditative practices based on individualisation.</description>
    <arm_group_label>Tele-Yoga Therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Primary care</intervention_name>
    <description>Patients will follow standard care provided by primary care physicians including analgesics and self care management.</description>
    <arm_group_label>Usual Care</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients having pain that was musculoskeletal, defined as regional (joints, limbs,&#xD;
             back, neck) or more generalized (fibromyalgia or chronic widespread pain);&#xD;
&#xD;
          -  Persistent pain ( ≥3 months) despite trying conventional treatment.&#xD;
&#xD;
          -  Access to virtual platform with internet.&#xD;
&#xD;
          -  Ready to give informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Schizophrenia,&#xD;
&#xD;
          -  Psychiatric disorder&#xD;
&#xD;
          -  Cognitive impairment&#xD;
&#xD;
          -  Suicidal ideation&#xD;
&#xD;
          -  Current illicit drug use&#xD;
&#xD;
          -  Terminal illness&#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>Naveen Meghwal</last_name>
    <role>Principal Investigator</role>
    <affiliation>NMP Medical Research Institute, India</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Neha Sharma</last_name>
    <role>Study Director</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>
  <overall_official>
    <last_name>Abhimanyu Kumar</last_name>
    <role>Study Chair</role>
    <affiliation>Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>NMP Medical Research Institute</name>
      <address>
        <city>Jaipur</city>
        <state>Rajasthan</state>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 9, 2020</study_first_submitted>
  <study_first_submitted_qc>July 9, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 10, 2020</study_first_posted>
  <last_update_submitted>July 9, 2020</last_update_submitted>
  <last_update_submitted_qc>July 9, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 10, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Tele-Yoga Therapy</keyword>
  <keyword>Chronic musculoskeletal pain</keyword>
  <keyword>Randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Musculoskeletal 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/NCT04466605
org study id: AU/NMP/0921
nct id: NCT04466605
lead sponsor: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Covid-19 outbreak and lockdown measures raised significant concerns over clinical management
      of chronic pain patients around the world. Patients with chronic musculoskeletal pain (CMSP)
      are at high risk of physical disability, psychological distress, and poor quality of life.
      Analgesic medications were main management during lockdown, but opioid-related concerns have
      prompted to find immediate alternatives.

      Present study was undertaken to determine whether patients randomized to tele-yoga therapy
      would experience less pain, disability and improved global health, adherence and
      satisfaction, compared with patients assigned to usual care.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: None (Open Label)
measure: Severity of pain
time frame: From baseline to 6-week post intervention
description: Pain was assessed using the Brief Pain Inventory (BPI), which rates the severity of pain on 4 items (current, worst, least, and average pain in past week)
measure: Interference of pain
time frame: From baseline to 6-week post intervention
description: Interference of pain in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life) were reported using BPI
measure: Global rating of change in pain
time frame: From baseline to 6-week post interventiona
description: 7-point global rating of pain change was used to assess change in pain
measure: Intervention specific satisfaction
time frame: From baseline to 6-week post interventiona
description: 10 point scale was used to assess intervention-specific satisfaction
arm group label: Tele-Yoga Therapy
arm group type: Experimental
description: All patients randomized to the intervention group had one to one yoga sessions with yoga therapist twice a week for 45 minutes on secure virtual platform. Patients were encouraged with home practice to follow everyday at least for 30-mins.
arm group label: Usual Care
arm group type: Active Comparator
description: Patients randomized to usual care continued to receive care for their chronic musculoskeletal pain from their primary care physician. There was no attempt by to influence clinical management unless an emergency arose
intervention type: Other
intervention name: Tele-yoga therapy
description: Each session included combinations of different yoga exercises, postures, yoga breathing, yoga relaxation techniques, yoga counselling and meditative practices based on individualisation.
arm group label: Tele-Yoga Therapy
intervention type: Other
intervention name: Primary care
description: Patients will follow standard care provided by primary care physicians including analgesics and self care management.
arm group label: Usual Care
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: No
last name: Naveen Meghwal
role: Principal Investigator
affiliation: NMP Medical Research Institute, India
last name: Neha Sharma
role: Study Director
affiliation: Aarogyam UK
last name: Bhavna Pandya
role: Study Chair
affiliation: Aarogyam UK
last name: Abhimanyu Kumar
role: Study Chair
affiliation: Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
facility: 
country: India
responsible party type: Sponsor
mesh term: Musculoskeletal Pain
sharing ipd: Undecided