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

Study Overview
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Brief Summary
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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.

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

Conditions
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Chronic Musculoskeletal Pain

Intervention / Treatment
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* Other: Tele-yoga therapy
* Other: Primary care


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Chronic musculoskeletal pain, Randomized controlled trial, Tele-Yoga Therapy