NCT04628130

Brief Summary

Chronic pain is a major health issue with substantial economic burden.To support chronic pain patients during the COVID-19 pandemic, yoga based self-managed intervention was delivered through tele-health platform. Project was designed as community-based program, creating new social networks for patients, health care providers and academics. Platform to deliver intervention and data collection was AiM COVID mobile app. Our objective was to determine the efficacy of Yoga based self-management intervention for people living with chronic pain pain intensity, disability and health related quality of life.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
42

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Sep 2020

Shorter than P25 for all trials

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 17, 2020

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 5, 2020

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

November 9, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 9, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 13, 2020

Completed
Last Updated

November 13, 2020

Status Verified

November 1, 2020

Enrollment Period

2 months

First QC Date

November 9, 2020

Last Update Submit

November 9, 2020

Conditions

Outcome Measures

Primary Outcomes (3)

  • Pain intensity and disability

    Pain intensity and related disability was measured through Brief Pain Inventory

    From baseline to 6 week post intervention

  • Health Related Quality of Life

    Quality of life was measured through 36-Item Short-Form Survey

    From baseline to 6 week post intervention

  • Self-efficacy of pain

    Self efficacy was measure through Pain Self-Efficacy Questionnaire

    From baseline to 6 week post intervention

Interventions

Yoga based self managed practices personalised to chronic pain patients

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Community based project in partnership with community organisation, health care providers and academic included chronic pain patients for yoga self management therapy.

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 (2)

Aarogyam UK

Leicester, Leicestershire, United Kingdom

Location

Patanjali Yog Peeth (UK) Trust

Glasgow, Scotland, United Kingdom

Location

MeSH Terms

Conditions

Chronic Pain

Interventions

Yoga

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Mind-Body TherapiesComplementary TherapiesTherapeuticsSpiritual TherapiesExercise Movement TechniquesPhysical Therapy Modalities

Study Officials

  • Neha Sharma

    Aarogyam UK

    PRINCIPAL INVESTIGATOR
  • Deepa Modi

    East Park Medical Centre, NHS trust, Leicester

    STUDY CHAIR
  • Vishwesh Kulkarni

    University of Warwick

    STUDY DIRECTOR
  • Sunita Poddar

    Patanjali Yog Peeth (UK) Trust

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 9, 2020

First Posted

November 13, 2020

Study Start

September 17, 2020

Primary Completion

November 5, 2020

Study Completion

November 9, 2020

Last Updated

November 13, 2020

Record last verified: 2020-11

Locations