NCT04466605

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 30, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

July 6, 2020

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

July 9, 2020

Completed
1 day until next milestone

First Posted

Study publicly available on registry

July 10, 2020

Completed
Last Updated

July 10, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

July 9, 2020

Last Update Submit

July 9, 2020

Conditions

Chronic Musculoskeletal Pain

Keywords

Tele-Yoga TherapyChronic musculoskeletal painRandomized controlled trial

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (2)

  • Global rating of change in pain

    From baseline to 6-week post interventiona

  • Intervention specific satisfaction

    From baseline to 6-week post interventiona

Study Arms (2)

Tele-Yoga Therapy

EXPERIMENTAL

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

Usual Care

ACTIVE COMPARATOR

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

Interventions

Tele-yoga therapyOTHER

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

Tele-Yoga Therapy
Primary careOTHER

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

Usual Care

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

NMP Medical Research Institute

Jaipur, Rajasthan, India

Location

MeSH Terms

Interventions

Primary Health Care

Intervention Hierarchy (Ancestors)

Comprehensive Health CarePatient Care ManagementHealth Services Administration

Study Officials

  • Naveen Meghwal

    NMP Medical Research Institute, India

    PRINCIPAL INVESTIGATOR

  • Neha Sharma

    Aarogyam UK

    STUDY DIRECTOR

  • Bhavna Pandya

    Aarogyam UK

    STUDY CHAIR

  • Abhimanyu Kumar

    Dr. Sarvepalli Radhakrishnan Rajasthan Ayurved University

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 9, 2020

First Posted

July 10, 2020

Study Start

March 30, 2020

Primary Completion

June 30, 2020

Study Completion

July 6, 2020

Last Updated

July 10, 2020

Record last verified: 2020-07

Locations

IN(1)