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

Chronic Musculoskeletal Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04466605
• Other study ID #: AU/NMP/0921
• Status: Completed
• Phase: N/A
• Start date: March 30, 2020
• Est. completion date: July 6, 2020

Study information

• Verified date: July 2020
• Source: Aarogyam UK
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 64
• Est. completion date: July 6, 2020
• Est. primary completion date: June 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Musculoskeletal Pain
• Musculoskeletal Pain

Intervention

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

Locations

Country	Name	City	State
India	NMP Medical Research Institute	Jaipur	Rajasthan

Sponsors (3)

Lead Sponsor	Collaborator
Aarogyam UK	Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University, NMP Medical Research Institute

Country where clinical trial is conducted

India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	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
Secondary	Intervention specific satisfaction	10 point scale was used to assess intervention-specific satisfaction	From baseline to 6-week post interventiona