NCT04457388

Brief Summary

Chronic pain is highly prevalent and associated with a large symptom burden, that is had been more concerning during Covid-19 outbreak and lockdown. Benefits of yoga in chronic pain management are very well known. With this background we developed Tele-Yoga therapy program and evaluated the success of this single arm study.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
18

participants targeted

Target at below P25 for not_applicable chronic-pain

Timeline
Completed

Started Mar 2020

Shorter than P25 for not_applicable chronic-pain

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 25, 2020

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 15, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 15, 2020

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

June 30, 2020

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 7, 2020

Completed
Last Updated

July 8, 2020

Status Verified

July 1, 2020

Enrollment Period

3 months

First QC Date

June 30, 2020

Last Update Submit

July 7, 2020

Conditions

Keywords

Tele-Yoga TherapyChronic Pain

Outcome Measures

Primary Outcomes (1)

  • Pain Intensity

    visual-analogic scale (VAS), using pain level from "no pain" (0) to "worst imaginable pain" (10)

    From baseline to 6-week post intervention

Secondary Outcomes (3)

  • Pain Disability

    From baseline to 6-week post intervention

  • Anxiety

    From Baseline to 6-week post intervention

  • Depression

    From baseline to 6-week post intervention

Study Arms (1)

Tele-Yoga Therapy

EXPERIMENTAL

Individualised Yoga therapy based on participant's clinical condition and personal needs. Twice a week sessions were carried out by trained and experienced Yoga therapist via video conference with each therapy for individualized based on each participant.

Other: Tele-Yoga Therapy

Interventions

Yoga practices combining with joint loosening exercises (Sukshma Vyayama), postures (Asana), breathing exercises (Pranayama), relaxation techniques and chanting ( A, U, M, and AUM { ૐ}) syllable chants meditation. Each session ended with home practice exercises given to the participants to practice everyday.

Tele-Yoga Therapy

Eligibility Criteria

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

You may qualify if:

  • Chronic pain for at least 3 months
  • Having access to internet and video calls

You may not qualify if:

  • Pregnant or breast-feeding women,
  • Patients not willing to give written consent
  • Patients with severe psychiatric or personality disorder
  • Malignancy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Aarogyam UK

Leicester, Leicestershire, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Neha Sharma

    Aarogyam UK

    PRINCIPAL INVESTIGATOR
  • Dipa Modi

    Aarogyam UK

    STUDY CHAIR
  • Bhavna Pandya

    Aarogyam UK

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 30, 2020

First Posted

July 7, 2020

Study Start

March 25, 2020

Primary Completion

June 15, 2020

Study Completion

June 15, 2020

Last Updated

July 8, 2020

Record last verified: 2020-07

Locations