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Clinical Trials/NCT04466605
NCT04466605
Completed
Not Applicable

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

Aarogyam UK1 site in 1 country64 target enrollmentStarted: March 30, 2020Last updated:

Overview

Phase
Not Applicable
Status
Completed
Sponsor
Aarogyam UK
Enrollment
64
Locations
1
Primary Endpoint
Interference of pain

Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

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

Outcomes

Primary Outcomes

Interference of pain

Time Frame: From baseline to 6-week post intervention

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

Severity of pain

Time Frame: From baseline to 6-week post intervention

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)

Secondary Outcomes

  • Global rating of change in pain(From baseline to 6-week post interventiona)
  • Intervention specific satisfaction(From baseline to 6-week post interventiona)

Investigators

Sponsor
Aarogyam UK
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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