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Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown

Primary Purpose

Chronic Musculoskeletal Pain

Status

Completed

Phase

Not Applicable

Locations

India

Study Type

Interventional

Intervention

Tele-yoga therapy

Primary care

About this trial

This is an interventional supportive care trial for Chronic Musculoskeletal Pain focused on measuring Tele-Yoga Therapy, Chronic musculoskeletal pain, Randomized controlled trial

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Patients having pain that was musculoskeletal, defined as regional (joints, limbs, back, neck) or more generalized (fibromyalgia or chronic widespread pain);
Persistent pain ( ≥3 months) despite trying conventional treatment.
Access to virtual platform with internet.
Ready to give informed consent

Exclusion Criteria:

Schizophrenia,
Psychiatric disorder
Cognitive impairment
Suicidal ideation
Current illicit drug use
Terminal illness

Sites / Locations

NMP Medical Research Institute

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Tele-Yoga Therapy

Usual Care

Arm 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.

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

Outcomes

Primary Outcome Measures

Severity of pain

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)

Interference of pain

Interference of pain in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life) were reported using BPI

Secondary Outcome Measures

Global rating of change in pain

7-point global rating of pain change was used to assess change in pain

Intervention specific satisfaction

10 point scale was used to assess intervention-specific satisfaction

Full Information

NCT ID

NCT04466605

First Posted

July 9, 2020

Last Updated

July 9, 2020

Sponsor

Aarogyam UK

Collaborators

NMP Medical Research Institute, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

1. Study Identification

Unique Protocol Identification Number

NCT04466605

Brief Title

Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown

Official Title

Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown: Randomized Clinical Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2020

Overall Recruitment Status

Completed

Study Start Date

March 30, 2020 (Actual)

Primary Completion Date

June 30, 2020 (Actual)

Study Completion Date

July 6, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Aarogyam UK

Collaborators

NMP Medical Research Institute, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Musculoskeletal Pain

Keywords

Tele-Yoga Therapy, Chronic musculoskeletal pain, Randomized controlled trial

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

64 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Tele-Yoga Therapy

Arm Type

Experimental

Arm Description

Arm Title

Usual Care

Arm Type

Active Comparator

Arm Description

Intervention Type

Other

Intervention Name(s)

Tele-yoga therapy

Intervention Description

Each session included combinations of different yoga exercises, postures, yoga breathing, yoga relaxation techniques, yoga counselling and meditative practices based on individualisation.

Intervention Type

Other

Intervention Name(s)

Primary care

Intervention Description

Patients will follow standard care provided by primary care physicians including analgesics and self care management.

Primary Outcome Measure Information:

Title

Severity of pain

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)

Time Frame

From baseline to 6-week post intervention

Title

Interference of pain

Description

Interference of pain in 7 areas (mood, physical activity, work, social activity, relations with others, sleep, enjoyment of life) were reported using BPI

Time Frame

From baseline to 6-week post intervention

Secondary Outcome Measure Information:

Title

Global rating of change in pain

Description

7-point global rating of pain change was used to assess change in pain

Time Frame

From baseline to 6-week post interventiona

Title

Intervention specific satisfaction

Description

10 point scale was used to assess intervention-specific satisfaction

Time Frame

From baseline to 6-week post interventiona

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients having pain that was musculoskeletal, defined as regional (joints, limbs, back, neck) or more generalized (fibromyalgia or chronic widespread pain); Persistent pain ( ≥3 months) despite trying conventional treatment. Access to virtual platform with internet. Ready to give informed consent Exclusion Criteria: Schizophrenia, Psychiatric disorder Cognitive impairment Suicidal ideation Current illicit drug use Terminal illness

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Naveen Meghwal

Organizational Affiliation

NMP Medical Research Institute, India

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Neha Sharma

Organizational Affiliation

Aarogyam UK

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Bhavna Pandya

Organizational Affiliation

Aarogyam UK

Official's Role

Study Chair

First Name & Middle Initial & Last Name & Degree

Abhimanyu Kumar

Organizational Affiliation

Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

Official's Role

Study Chair

Facility Information:

Facility Name

NMP Medical Research Institute

City

Jaipur

State/Province

Rajasthan

Country

India

12. IPD Sharing Statement

Plan to Share IPD

Undecided

Learn more about this trial

Effect of Tele-Yoga Therapy on Patients With Chronic Musculoskeletal Pain During Covid-19 Lockdown

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