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

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

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.

Study Overview

• Status: Completed
• Conditions: Chronic Musculoskeletal Pain
• Intervention / Treatment: Other: Tele-yoga therapy; Other: Primary care

• Study Type: Interventional
• Enrollment (Actual): 64
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Rajasthan
    • Jaipur, Rajasthan, India
      • NMP Medical Research Institute

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tele-Yoga Therapy; 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.	Other: Tele-yoga therapy; Each session included combinations of different yoga exercises, postures, yoga breathing, yoga relaxation techniques, yoga counselling and meditative practices based on individualisation.
Active Comparator: Usual Care; 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	Other: Primary care; Patients will follow standard care provided by primary care physicians including analgesics and self care management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	From baseline to 6-week post intervention
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	From baseline to 6-week post intervention

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Global rating of change in pain	7-point global rating of pain change was used to assess change in pain	From baseline to 6-week post interventiona
Intervention specific satisfaction	10 point scale was used to assess intervention-specific satisfaction	From baseline to 6-week post interventiona

Collaborators and Investigators

• Sponsor: Aarogyam UK
• Collaborators: NMP Medical Research Institute; Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University
• Investigators: Principal Investigator: Naveen Meghwal, NMP Medical Research Institute, India; Study Chair: Bhavna Pandya, Aarogyam UK; Study Chair: Abhimanyu Kumar, Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

Study record dates

Study Major Dates

• Study Start (Actual): March 30, 2020
• Primary Completion (Actual): June 30, 2020
• Study Completion (Actual): July 6, 2020

Study Registration Dates

• First Submitted: July 9, 2020
• First Submitted That Met QC Criteria: July 9, 2020
• First Posted (Actual): July 10, 2020

Study Record Updates

• Last Update Posted (Actual): July 10, 2020
• Last Update Submitted That Met QC Criteria: July 9, 2020
• Last Verified: July 1, 2020

More Information

Terms related to this study

• Keywords: Randomized controlled trial; Tele-Yoga Therapy; Chronic musculoskeletal pain
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Musculoskeletal Diseases; Muscular Diseases; Musculoskeletal Pain
• Other Study ID Numbers: AU/NMP/0921

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No